Trial Outcomes & Findings for Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma (NCT NCT01345019)

NCT ID: NCT01345019

Last Updated: 2022-11-08

Results Overview

A skeletal-related event (SRE) is defined as one of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression. Time to first on-study SRE is defined as the time interval (in days) from the randomization date to the date of first occurrence of on-study SRE. If there was no known event, and the participant was monitored for any one of the four SRE components, time to first on-study SRE was censored at the end of the treatment phase date or the primary analysis data cut-off date, whichever came first.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1718 participants
• Primary outcome timeframe: From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively.
• Results posted on: 2022-11-08

Participant Flow

This study was conducted at 259 centers across 29 countries in Europe, North America, Asia, Australia/New Zealand, and Japan. Participants were enrolled from 17 May 2012 to 29 March 2016.

Randomization was stratified according to: * intent to undergo autologous peripheral blood stem cell (PBSC) transplantation * the antimyeloma agent being utilized/planned to be utilized in first-line therapy * stage (International Staging System [ISS]) at diagnosis * previous SRE (yes or no) * region (Japan yes or no)

Participant milestones

Measure	Zoledronic Acid Participants randomized to receive zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneously (SC) once every 4 weeks (Q4W) in the double-blind treatment phase. In the open-label treatment phase, remaining participants received denosumab 120 mg SC Q4W.	Denosumab Participants randomized to receive denosumab 120 mg subcutaneously (SC) plus placebo to zoledronic acid intravenously once every 4 weeks (Q4W) in the double-blind treatment phase. In the open-label treatment phase, remaining participants received denosumab 120 mg SC Q4W.
Blinded Treatment Phase STARTED	859	859
Blinded Treatment Phase Received Treatment	852	850
Blinded Treatment Phase COMPLETED	541	555
Blinded Treatment Phase NOT COMPLETED	318	304
Open Label Treatment Phase STARTED	418	426
Open Label Treatment Phase COMPLETED	227	233
Open Label Treatment Phase NOT COMPLETED	191	193

Reasons for withdrawal

Measure	Zoledronic Acid Participants randomized to receive zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneously (SC) once every 4 weeks (Q4W) in the double-blind treatment phase. In the open-label treatment phase, remaining participants received denosumab 120 mg SC Q4W.	Denosumab Participants randomized to receive denosumab 120 mg subcutaneously (SC) plus placebo to zoledronic acid intravenously once every 4 weeks (Q4W) in the double-blind treatment phase. In the open-label treatment phase, remaining participants received denosumab 120 mg SC Q4W.
Blinded Treatment Phase Death	147	137
Blinded Treatment Phase Withdrawal by Subject	103	112
Blinded Treatment Phase Completed Survival Follow-up	21	9
Blinded Treatment Phase Disease Progression	12	10
Blinded Treatment Phase Adverse Event	6	13
Blinded Treatment Phase Administrative Decision	10	8
Blinded Treatment Phase Noncompliance	5	3
Blinded Treatment Phase Ineligibility Determined	1	6
Blinded Treatment Phase Protocol Deviation	5	0
Blinded Treatment Phase Other, Not Specified	2	3
Blinded Treatment Phase Lost to Follow-up	6	3
Open Label Treatment Phase Death	49	48
Open Label Treatment Phase Withdrawal by Subject	49	47
Open Label Treatment Phase Adverse Event	30	51
Open Label Treatment Phase Administrative Decision	30	15
Open Label Treatment Phase Disease Progression	17	18
Open Label Treatment Phase Noncompliance	5	4
Open Label Treatment Phase Lost to Follow-up	1	2
Open Label Treatment Phase Pregnancy	1	0
Open Label Treatment Phase Other, Not Specified	9	7
Open Label Treatment Phase Protocol Violation	0	1

Baseline Characteristics

Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma

Baseline characteristics by cohort

Measure	Zoledronic Acid n=859 Participants Participants randomized to receive zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneously once every 4 weeks in the double-blind treatment phase.	Denosumab n=859 Participants Participants randomized to receive denosumab 120 mg subcutaneously plus placebo to zoledronic acid intravenously once every 4 weeks in the double-blind treatment phase.	Total n=1718 Participants Total of all reporting groups
Age, Continuous	63.3 years STANDARD_DEVIATION 10.5 • n=5 Participants	63.5 years STANDARD_DEVIATION 10.6 • n=7 Participants	63.4 years STANDARD_DEVIATION 10.6 • n=5 Participants
Age, Customized < 65 years	464 Participants n=5 Participants	472 Participants n=7 Participants	936 Participants n=5 Participants
Age, Customized ≥ 65 years	395 Participants n=5 Participants	387 Participants n=7 Participants	782 Participants n=5 Participants
Sex: Female, Male Female	386 Participants n=5 Participants	397 Participants n=7 Participants	783 Participants n=5 Participants
Sex: Female, Male Male	473 Participants n=5 Participants	462 Participants n=7 Participants	935 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	35 Participants n=5 Participants	35 Participants n=7 Participants	70 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	819 Participants n=5 Participants	823 Participants n=7 Participants	1642 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized White	699 Participants n=5 Participants	711 Participants n=7 Participants	1410 Participants n=5 Participants
Race/Ethnicity, Customized Asian	101 Participants n=5 Participants	107 Participants n=7 Participants	208 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	36 Participants n=5 Participants	29 Participants n=7 Participants	65 Participants n=5 Participants
Race/Ethnicity, Customized Other	19 Participants n=5 Participants	10 Participants n=7 Participants	29 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Multiracial	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Missing	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 (Fully active)	259 Participants n=5 Participants	263 Participants n=7 Participants	522 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 1 (Restricted but ambulatory)	413 Participants n=5 Participants	400 Participants n=7 Participants	813 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 2 (Ambulatory but unable to work)	187 Participants n=5 Participants	196 Participants n=7 Participants	383 Participants n=5 Participants
Skeletal Related Event History Any Skeletal Related Event	577 participants n=5 Participants	567 participants n=7 Participants	1144 participants n=5 Participants
Skeletal Related Event History Pathological fracture	463 participants n=5 Participants	479 participants n=7 Participants	942 participants n=5 Participants
Skeletal Related Event History Spinal cord compression	115 participants n=5 Participants	92 participants n=7 Participants	207 participants n=5 Participants
Skeletal Related Event History Radiation therapy to bone	139 participants n=5 Participants	118 participants n=7 Participants	257 participants n=5 Participants
Skeletal Related Event History Surgery to bone	144 participants n=5 Participants	142 participants n=7 Participants	286 participants n=5 Participants
Summary of Randomization Stratifications Intent to undergo PBSC transplantation: Yes	465 participants n=5 Participants	465 participants n=7 Participants	930 participants n=5 Participants
Summary of Randomization Stratifications Intent to undergo PBSC transplantation: No	394 participants n=5 Participants	394 participants n=7 Participants	788 participants n=5 Participants
Summary of Randomization Stratifications Anti-myeloma agent utilized/planned: Novel	821 participants n=5 Participants	819 participants n=7 Participants	1640 participants n=5 Participants
Summary of Randomization Stratifications Anti-myeloma agent utilized/planned: Non-novel	38 participants n=5 Participants	40 participants n=7 Participants	78 participants n=5 Participants
Summary of Randomization Stratifications ISS stage at diagnosis: I	268 participants n=5 Participants	263 participants n=7 Participants	531 participants n=5 Participants
Summary of Randomization Stratifications ISS stage at diagnosis: II	313 participants n=5 Participants	319 participants n=7 Participants	632 participants n=5 Participants
Summary of Randomization Stratifications ISS stage at diagnosis: III	278 participants n=5 Participants	277 participants n=7 Participants	555 participants n=5 Participants
Summary of Randomization Stratifications Previous SRE : Yes	484 participants n=5 Participants	481 participants n=7 Participants	965 participants n=5 Participants
Summary of Randomization Stratifications Previous SRE : No	375 participants n=5 Participants	378 participants n=7 Participants	753 participants n=5 Participants
Summary of Randomization Stratifications Region: Japan	18 participants n=5 Participants	24 participants n=7 Participants	42 participants n=5 Participants
Summary of Randomization Stratifications Region: Non-Japan	841 participants n=5 Participants	835 participants n=7 Participants	1676 participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively.

Population: All randomized participants

A skeletal-related event (SRE) is defined as one of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression. Time to first on-study SRE is defined as the time interval (in days) from the randomization date to the date of first occurrence of on-study SRE. If there was no known event, and the participant was monitored for any one of the four SRE components, time to first on-study SRE was censored at the end of the treatment phase date or the primary analysis data cut-off date, whichever came first.

Outcome measures

Measure	Zoledronic Acid n=859 Participants Participants randomized to receive zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneously once every 4 weeks in the double-blind treatment phase.	Denosumab n=859 Participants Participants randomized to receive denosumab 120 mg subcutaneously plus placebo to zoledronic acid intravenously once every 4 weeks in the double-blind treatment phase.
Time to First On-study Skeletal Related Event	730.0 days Interval 504.0 to 1014.0	695.0 days Interval 448.0 to Could not be estimated due to the low number of events

PRIMARY outcome

Timeframe: From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively.

Population: All randomized participants

A skeletal-related event (SRE) is defined as one of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression.

Outcome measures

Measure	Zoledronic Acid n=859 Participants Participants randomized to receive zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneously once every 4 weeks in the double-blind treatment phase.	Denosumab n=859 Participants Participants randomized to receive denosumab 120 mg subcutaneously plus placebo to zoledronic acid intravenously once every 4 weeks in the double-blind treatment phase.
Percentage of Participants With an On-study Skeletal Related Event	44.6 percentage of participants Interval 41.3 to 47.9	43.8 percentage of participants Interval 40.5 to 47.1

PRIMARY outcome

Timeframe: From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively. The Kaplan-Meier estimate at weeks 25, 49 and 109 is reported.

Population: All randomized participants

A skeletal-related event (SRE) is defined as one of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression.

Outcome measures

Measure	Zoledronic Acid n=859 Participants Participants randomized to receive zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneously once every 4 weeks in the double-blind treatment phase.	Denosumab n=859 Participants Participants randomized to receive denosumab 120 mg subcutaneously plus placebo to zoledronic acid intravenously once every 4 weeks in the double-blind treatment phase.
Kaplan-Meier Estimate of Percentage of Participants With an On-study Skeletal Related Event At Week 25	36.5 percentage of participants Interval 33.3 to 39.9	35.9 percentage of participants Interval 32.7 to 39.3
Kaplan-Meier Estimate of Percentage of Participants With an On-study Skeletal Related Event At Week 49	43.2 percentage of participants Interval 39.7 to 46.8	43.7 percentage of participants Interval 40.2 to 47.3
Kaplan-Meier Estimate of Percentage of Participants With an On-study Skeletal Related Event At Week 109	50.6 percentage of participants Interval 46.6 to 54.6	50.5 percentage of participants Interval 46.6 to 54.5

SECONDARY outcome

Timeframe: From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively.

Population: All randomized participants

A skeletal-related event (SRE) is defined as one of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression. Time to first on-study SRE is defined as the time interval (in days) from the randomization date to the date of first occurrence of on-study SRE. If there was no known event, and the participant was monitored for any one of the four SRE components, time to first on-study SRE was censored at the end of the treatment phase date or the primary analysis data cut-off date, whichever came first.

Outcome measures

Measure	Zoledronic Acid n=859 Participants Participants randomized to receive zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneously once every 4 weeks in the double-blind treatment phase.	Denosumab n=859 Participants Participants randomized to receive denosumab 120 mg subcutaneously plus placebo to zoledronic acid intravenously once every 4 weeks in the double-blind treatment phase.
Time to First On-study Skeletal Related Event - Superiority Analysis	730.0 days Interval 504.0 to 1014.0	695.0 days Interval 448.0 to Could not be estimated due to the low number of events

SECONDARY outcome

Timeframe: From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively.

Population: All randomized participants

A skeletal-related event (SRE) is defined as one of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression. Time to first on-study SRE is defined as the time interval (in days) from the randomization date to the date of first occurrence of on-study SRE. Time to a subsequent SRE is defined, similarly to the time to first on-study SRE, as the time interval from the randomization date to the date of a subsequent occurrence of on-study SRE, which had to be at least 21 days after the previous SRE.

A multiple event analysis was used, which accounts for both the absolute number of SREs and for the time between two consecutive events, and therefore, provides a more sensitive assessment of the risk of experiencing an SRE. The average number of events per patient is reported.

Outcome measures

Measure	Zoledronic Acid n=859 Participants Participants randomized to receive zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneously once every 4 weeks in the double-blind treatment phase.	Denosumab n=859 Participants Participants randomized to receive denosumab 120 mg subcutaneously plus placebo to zoledronic acid intravenously once every 4 weeks in the double-blind treatment phase.
Time to First and Subsequent On-Study Skeletal Related Event - Number of Events Per Patient	0.66 events/patient	0.66 events/patient

SECONDARY outcome

Timeframe: From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively.

Population: All randomized participants

A skeletal-related event (SRE) is defined as one of the following: pathologic fracture (vertebral or non-vertebral), radiation therapy to bone (including the use of radioisotopes), surgery to bone, or spinal cord compression. Time to first on-study SRE is defined as the time interval (in days) from the randomization date to the date of first occurrence of on-study SRE. Time to a subsequent SRE is defined, similarly to the time to first on-study SRE, as the time interval from the randomization date to the date of a subsequent occurrence of on-study SRE, which had to be at least 21 days after the previous SRE.

A multiple event analysis was used, which accounts for both the absolute number of SREs and for the time between two consecutive events, and therefore, provides a more sensitive assessment of the risk of experiencing an SRE. The total number of events is reported.

Outcome measures

Measure	Zoledronic Acid n=859 Participants Participants randomized to receive zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneously once every 4 weeks in the double-blind treatment phase.	Denosumab n=859 Participants Participants randomized to receive denosumab 120 mg subcutaneously plus placebo to zoledronic acid intravenously once every 4 weeks in the double-blind treatment phase.
Time to First and Subsequent On-Study Skeletal Related Event - Number of Events	565 skeletal-related events	565 skeletal-related events

SECONDARY outcome

Timeframe: From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively.

Population: All randomized participants

Overall survival was defined as the time interval (in days) from the randomization date to the date of death. If a participant was still alive at the primary analysis data cut-off date or was lost to follow-up by the primary analysis data cut-off date, survival time was censored at their last contact date or the primary analysis data cut-off date, whichever was first.

Outcome measures

Measure	Zoledronic Acid n=859 Participants Participants randomized to receive zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneously once every 4 weeks in the double-blind treatment phase.	Denosumab n=859 Participants Participants randomized to receive denosumab 120 mg subcutaneously plus placebo to zoledronic acid intravenously once every 4 weeks in the double-blind treatment phase.
Overall Survival	NA days Not estimable, the median survival and 95% CI were not reached	1507.0 days The 95% CI was not estimable as there were no participants in the risk set who survived at the median time

SECONDARY outcome

Timeframe: From randomization until the primary analysis data cut-off date of 19 July 2016 (per protocol); median time on study was 17.6 and 17.3 months in each treatment group respectively.

Population: All randomized participants

Outcome measures

Measure	Zoledronic Acid n=859 Participants Participants randomized to receive zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneously once every 4 weeks in the double-blind treatment phase.	Denosumab n=859 Participants Participants randomized to receive denosumab 120 mg subcutaneously plus placebo to zoledronic acid intravenously once every 4 weeks in the double-blind treatment phase.
Percentage of Participants Who Died	15.0 percentage of participants Interval 12.6 to 17.4	14.1 percentage of participants Interval 11.8 to 16.4

Adverse Events

DB: Zoledronic Acid

Serious events: 447 serious events

Other events: 778 other events

Deaths: 0 deaths

DB: Denosumab

Serious events: 434 serious events

Other events: 757 other events

Deaths: 0 deaths

OL: Zoledronic Acid / Denosumab

Serious events: 159 serious events

Other events: 313 other events

Deaths: 0 deaths

OL: Denosumab / Denosumab

Serious events: 156 serious events

Other events: 312 other events

Deaths: 0 deaths

Serious adverse events

Measure	DB: Zoledronic Acid n=852 participants at risk Participants received zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneously once every 4 weeks (Q4W) in the double-blind (DB) treatment phase.	DB: Denosumab n=850 participants at risk Participants received denosumab 120 mg subcutaneously plus placebo to zoledronic acid intravenously once every 4 weeks (Q4W) in the double-blind (DB) treatment phase.	OL: Zoledronic Acid / Denosumab n=418 participants at risk Participants who received zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneously (SC) once every 4 weeks (Q4W) in the double-blind treatment phase received denosumab 120 mg SC Q4W in the open-label (OL) treatment phase.	OL: Denosumab / Denosumab n=426 participants at risk Participants who received denosumab 120 mg subcutaneously (SC) plus placebo to zoledronic acid intravenously once every 4 weeks (Q4W) in the double-blind treatment phase received denosumab 120 mg SC Q4W in the open-label (OL) treatment phase.
Nervous system disorders Haemorrhagic stroke	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Hemiparesis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Hypoaesthesia	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Hemiplegia	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Ischaemic cerebral infarction	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Ischaemic stroke	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Lacunar infarction	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Loss of consciousness	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Lumbosacral radiculopathy	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Nerve degeneration	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Neuropathy peripheral	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Paralysis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Paraparesis	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Paraplegia	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Erysipelas	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Paresis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Polyneuropathy	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Presyncope	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Radiculopathy	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Sciatica	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Seizure	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Seizure like phenomena	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Spinal cord compression	0.94% 8/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.47% 4/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Subarachnoid haemorrhage	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Syncope	1.1% 9/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.82% 7/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.47% 2/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Transient ischaemic attack	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Product Issues Device breakage	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Product Issues Device failure	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Product Issues Device occlusion	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Psychiatric disorders Anxiety	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Psychiatric disorders Completed suicide	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Psychiatric disorders Confusional state	0.35% 3/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.59% 5/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Psychiatric disorders Delirium	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.47% 4/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.47% 2/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Psychiatric disorders Depression	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Psychiatric disorders Disorientation	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Psychiatric disorders Major depression	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Psychiatric disorders Mental status changes	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Psychiatric disorders Mutism	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Psychiatric disorders Psychotic disorder	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Psychiatric disorders Suicide attempt	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Renal and urinary disorders Acute kidney injury	2.8% 24/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	2.0% 17/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.9% 8/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.47% 2/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Renal and urinary disorders Bladder perforation	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Renal and urinary disorders Chronic kidney disease	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Renal and urinary disorders Cystitis haemorrhagic	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Renal and urinary disorders Dysuria	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Renal and urinary disorders Haematuria	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Renal and urinary disorders Nephrolithiasis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Renal and urinary disorders Renal colic	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Renal and urinary disorders Renal disorder	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Renal and urinary disorders Renal failure	0.82% 7/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.47% 4/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.4% 6/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Renal and urinary disorders Renal impairment	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Renal and urinary disorders Ureteric obstruction	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Renal and urinary disorders Ureterolithiasis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Renal and urinary disorders Urinary retention	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.48% 2/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Reproductive system and breast disorders Adenomyosis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Reproductive system and breast disorders Scrotal oedema	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Reproductive system and breast disorders Testicular mass	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Blood and lymphatic system disorders Agranulocytosis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Blood and lymphatic system disorders Anaemia	3.1% 26/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.4% 12/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.2% 5/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.9% 8/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Blood and lymphatic system disorders Autoimmune haemolytic anaemia	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Blood and lymphatic system disorders Bicytopenia	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Blood and lymphatic system disorders Bone marrow failure	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Blood and lymphatic system disorders Febrile neutropenia	2.9% 25/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	2.7% 23/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.7% 7/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.4% 6/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Blood and lymphatic system disorders Haemolytic anaemia	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Blood and lymphatic system disorders Hyperviscosity syndrome	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Blood and lymphatic system disorders Leukopenia	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.48% 2/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Blood and lymphatic system disorders Neutropenia	1.5% 13/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.47% 4/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.96% 4/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.70% 3/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Blood and lymphatic system disorders Pancytopenia	0.47% 4/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.72% 3/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Blood and lymphatic system disorders Thrombocytopenia	1.4% 12/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.1% 9/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.48% 2/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.6% 7/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Acute coronary syndrome	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.72% 3/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Acute myocardial infarction	0.70% 6/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Angina pectoris	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Angina unstable	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.48% 2/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Atrial fibrillation	1.2% 10/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.47% 4/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.48% 2/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Atrial flutter	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Atrial tachycardia	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Bradycardia	0.47% 4/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Cardiac amyloidosis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Cardiac arrest	1.3% 11/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.71% 6/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Cardiac disorder	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Cardiac failure	0.82% 7/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.3% 11/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.72% 3/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.94% 4/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Cardiac failure acute	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Cardiac failure chronic	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Cardiac failure congestive	0.59% 5/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.59% 5/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.70% 3/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Cardio-respiratory arrest	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Cardiopulmonary failure	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Cardiovascular insufficiency	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Coronary artery disease	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Left ventricular failure	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Mitral valve stenosis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Myocardial infarction	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.47% 2/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Myocardial ischaemia	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Myocarditis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Palpitations	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Pericarditis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Sinus bradycardia	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Sinus node dysfunction	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Sinus tachycardia	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Supraventricular tachycardia	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Tachyarrhythmia	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Tachycardia	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Tricuspid valve incompetence	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Congenital, familial and genetic disorders Aplasia	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Ear and labyrinth disorders Vertigo	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Ear and labyrinth disorders Vertigo positional	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Endocrine disorders Adrenal insufficiency	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Endocrine disorders Hypercalcaemia of malignancy	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Endocrine disorders Hyperparathyroidism primary	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Endocrine disorders Steroid withdrawal syndrome	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Eye disorders Cataract	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.48% 2/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Eye disorders Diplopia	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Eye disorders Exophthalmos	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Eye disorders Extraocular muscle paresis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Abdominal discomfort	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Abdominal distension	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Abdominal hernia	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Abdominal incarcerated hernia	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Abdominal pain	0.59% 5/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.96% 4/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Abdominal pain upper	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Abdominal wall haematoma	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Chronic gastritis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Colitis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Colitis ischaemic	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Constipation	0.47% 4/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.48% 2/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Diarrhoea	1.2% 10/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.1% 9/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.94% 4/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Diarrhoea haemorrhagic	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Duodenal ulcer	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Dysphagia	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Enteritis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Gastritis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Gastritis erosive	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Gastrointestinal amyloidosis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.59% 5/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Gastrointestinal perforation	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Gingivitis ulcerative	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Hiatus hernia	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Ileus	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.48% 2/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Inguinal hernia	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.70% 3/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Intestinal haemorrhage	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Intestinal obstruction	0.35% 3/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.48% 2/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Large intestine perforation	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Large intestine polyp	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.47% 2/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Mechanical ileus	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Melaena	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Nausea	0.47% 4/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.47% 4/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Oesophagitis	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Pancreatitis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Proctitis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Rectal haemorrhage	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.47% 4/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Stomatitis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Subileus	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Umbilical hernia	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Vomiting	1.3% 11/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.82% 7/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.72% 3/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.70% 3/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
General disorders Asthenia	0.82% 7/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.2% 5/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
General disorders Chest pain	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
General disorders Chills	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
General disorders Death	0.35% 3/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
General disorders Disease progression	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
General disorders Fatigue	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.48% 2/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
General disorders Gait disturbance	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
General disorders General physical health deterioration	1.2% 10/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.2% 10/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.48% 2/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.4% 6/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
General disorders Generalised oedema	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
General disorders Hyperpyrexia	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
General disorders Hyperthermia	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
General disorders Localised oedema	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
General disorders Malaise	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
General disorders Mucosal ulceration	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
General disorders Multiple organ dysfunction syndrome	0.70% 6/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.59% 5/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.72% 3/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
General disorders Non-cardiac chest pain	0.59% 5/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.47% 4/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.47% 2/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
General disorders Oedema peripheral	0.35% 3/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.59% 5/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.48% 2/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
General disorders Performance status decreased	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
General disorders Pyrexia	3.3% 28/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	2.8% 24/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.48% 2/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.94% 4/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
General disorders Sudden cardiac death	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
General disorders Sudden death	0.59% 5/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Hepatobiliary disorders Acute hepatic failure	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Hepatobiliary disorders Bile duct stenosis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Hepatobiliary disorders Cholangitis acute	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Hepatobiliary disorders Cholecystitis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Hepatobiliary disorders Cholelithiasis	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.48% 2/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Hepatobiliary disorders Drug-induced liver injury	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Hepatobiliary disorders Hepatitis toxic	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Immune system disorders Acute graft versus host disease	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Immune system disorders Acute graft versus host disease in intestine	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Immune system disorders Anaphylactic reaction	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Immune system disorders Hypersensitivity	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Abscess bacterial	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Adenoviral haemorrhagic cystitis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Appendicitis	0.35% 3/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Arthritis bacterial	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Arthritis infective	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Atypical pneumonia	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Bacteraemia	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Bacterial infection	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Bacterial pyelonephritis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Bacterial sepsis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Bronchiolitis	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Bronchitis	0.82% 7/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.3% 11/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.96% 4/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.47% 2/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Bursitis infective	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Cellulitis	0.59% 5/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.47% 4/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.94% 4/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Cellulitis orbital	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Cholecystitis infective	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Chronic sinusitis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Clostridium bacteraemia	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Clostridium difficile colitis	0.47% 4/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.71% 6/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.47% 2/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Clostridium difficile infection	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Creutzfeldt-Jakob disease	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Cystitis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Cytomegalovirus chorioretinitis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Cytomegalovirus infection	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Device related infection	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Diarrhoea infectious	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Diverticulitis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Encephalitis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Escherichia sepsis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Escherichia urinary tract infection	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Extradural abscess	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Febrile infection	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Folliculitis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Gastroenteritis	0.35% 3/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.47% 2/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Gastroenteritis viral	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Gingivitis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Herpes zoster	1.1% 9/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.59% 5/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Human herpesvirus 6 infection	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Infection	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Infection in an immunocompromised host	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Infection reactivation	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Influenza	0.70% 6/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.2% 10/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.72% 3/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.2% 5/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Intervertebral discitis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Lower respiratory tract infection	1.4% 12/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.59% 5/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Lower respiratory tract infection fungal	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Lower respiratory tract infection viral	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Lung infection	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.48% 2/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Meningitis meningococcal	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Meningitis pneumococcal	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Necrotising fasciitis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Neutropenic infection	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Neutropenic sepsis	0.35% 3/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Osteomyelitis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Otitis media	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Parainfluenzae virus infection	0.35% 3/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Perineal abscess	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Periodontitis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Peritonitis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Peritonsillar abscess	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Pneumococcal sepsis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Pneumocystis jirovecii infection	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Pneumocystis jirovecii pneumonia	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Pneumonia	9.6% 82/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	9.3% 79/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	8.1% 34/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	7.3% 31/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Pneumonia bacterial	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Pneumonia klebsiella	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Pneumonia legionella	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Pneumonia pneumococcal	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Pneumonia respiratory syncytial viral	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Pneumonia staphylococcal	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Pneumonia viral	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Post procedural infection	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Post procedural sepsis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Postoperative wound infection	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Pseudomonal sepsis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Pulmonary mycosis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Respiratory tract infection	0.94% 8/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.82% 7/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.9% 8/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.2% 5/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Respiratory tract infection fungal	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Respiratory tract infection viral	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Salmonellosis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Scrotal abscess	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Sepsis	2.8% 24/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	2.2% 19/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.9% 8/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	2.6% 11/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Sepsis syndrome	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Septic necrosis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Septic shock	0.82% 7/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.71% 6/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.7% 7/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.47% 2/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Sinusitis	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Spinal cord infection	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Staphylococcal bacteraemia	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Staphylococcal sepsis	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Staphylococcal skin infection	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Tonsillitis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Tracheobronchitis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Upper respiratory tract infection	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.82% 7/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.48% 2/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.47% 2/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Urinary tract infection	1.1% 9/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.71% 6/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.48% 2/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Urinary tract infection bacterial	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Urosepsis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Varicella	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Viral infection	0.35% 3/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Viral myositis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Wound infection	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Abdominal injury	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Anastomotic leak	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Bone contusion	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Brain contusion	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Concussion	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Fall	0.70% 6/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.70% 3/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Femoral neck fracture	0.82% 7/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Hand fracture	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Head injury	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Hip fracture	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Humerus fracture	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Joint dislocation	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.94% 8/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.47% 4/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Patella fracture	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Rib fracture	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.47% 2/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.70% 3/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Sternal fracture	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Subdural haematoma	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.59% 5/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.71% 6/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Transfusion related complication	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Investigations Alanine aminotransferase increased	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Investigations Aspartate aminotransferase increased	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Investigations Bilirubin conjugated increased	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Investigations Blood bilirubin increased	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Investigations Blood creatine increased	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Investigations Blood creatinine increased	0.35% 3/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Investigations Blood electrolytes abnormal	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Investigations Blood immunoglobulin G increased	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Investigations Blood immunoglobulin M increased	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Investigations Blood lactate dehydrogenase increased	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Investigations Body temperature increased	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Investigations Bone marrow plasmacyte count increased	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Investigations C-reactive protein increased	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Investigations Chest X-ray abnormal	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Investigations Eastern Cooperative Oncology Group performance status worsened	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Investigations Haemoglobin decreased	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Investigations Heart rate irregular	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Investigations Light chain analysis increased	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Investigations Liver function test abnormal	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Investigations Monoclonal immunoglobulin present	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Investigations Neutrophil count decreased	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Investigations Platelet count decreased	0.70% 6/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.47% 2/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Investigations Weight decreased	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Investigations White blood cell count decreased	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Metabolism and nutrition disorders Cachexia	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Metabolism and nutrition disorders Decreased appetite	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Metabolism and nutrition disorders Dehydration	1.4% 12/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.2% 10/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.72% 3/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Metabolism and nutrition disorders Electrolyte imbalance	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Metabolism and nutrition disorders Failure to thrive	0.35% 3/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Metabolism and nutrition disorders Fluid imbalance	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Metabolism and nutrition disorders Gout	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Metabolism and nutrition disorders Haemosiderosis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Metabolism and nutrition disorders Hypercalcaemia	0.94% 8/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.70% 3/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Metabolism and nutrition disorders Hyperproteinaemia	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Metabolism and nutrition disorders Hyperuricaemia	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Metabolism and nutrition disorders Hypocalcaemia	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.94% 8/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.48% 2/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.47% 2/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Metabolism and nutrition disorders Hypoglycaemia	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Metabolism and nutrition disorders Hypokalaemia	0.82% 7/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.47% 2/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Metabolism and nutrition disorders Hyponatraemia	0.35% 3/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Metabolism and nutrition disorders Lactic acidosis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Metabolism and nutrition disorders Tumour lysis syndrome	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Arthralgia	0.59% 5/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Back pain	1.9% 16/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.1% 9/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Bone pain	0.82% 7/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.72% 3/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Flank pain	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Joint effusion	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Muscular weakness	0.35% 3/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Myalgia	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Neck pain	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	1.5% 13/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	2.1% 18/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	2.6% 11/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	2.8% 12/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Pain in extremity	0.59% 5/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Pathological fracture	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Vertebral lesion	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.72% 3/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basosquamous carcinoma of skin	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer recurrent	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myelomonocytic leukaemia	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer metastatic	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of pleura	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of renal pelvis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm of orbit	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine tumour	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer stage I	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paraproteinaemia	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell leukaemia	0.47% 4/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.47% 2/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	1.9% 16/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	2.1% 18/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.72% 3/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	2.3% 10/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma recurrent	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasmacytoma	0.47% 4/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.82% 7/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.2% 5/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.35% 3/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Basilar migraine	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Brain injury	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Cauda equina syndrome	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Cerebral haemorrhage	0.47% 4/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.48% 2/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Cerebral ischaemia	0.35% 3/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Cerebral vasoconstriction	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Cerebrovascular accident	0.59% 5/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.59% 5/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Cognitive disorder	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Coma	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Depressed level of consciousness	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Dizziness	0.47% 4/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Encephalopathy	0.35% 3/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.48% 2/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Epilepsy	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Generalised tonic-clonic seizure	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Haemorrhage intracranial	0.35% 3/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.48% 2/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Aspiration	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Bronchopneumopathy	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.47% 4/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.47% 4/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.72% 3/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.70% 3/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.2% 10/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.59% 5/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.48% 2/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.47% 2/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.35% 3/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.35% 3/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.35% 3/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Nasal discomfort	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Non-cardiogenic pulmonary oedema	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.47% 4/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.71% 6/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.71% 6/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.48% 2/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Productive cough	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Pulmonary artery thrombosis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.5% 13/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.9% 16/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.2% 5/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.70% 3/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.48% 2/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.70% 3/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.3% 11/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.47% 4/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.96% 4/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.47% 2/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Stridor	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Skin and subcutaneous tissue disorders Drug eruption	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Skin and subcutaneous tissue disorders Erythema multiforme	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Skin and subcutaneous tissue disorders Keloid scar	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Skin and subcutaneous tissue disorders Purpura	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Skin and subcutaneous tissue disorders Rash	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Skin and subcutaneous tissue disorders Skin disorder	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Surgical and medical procedures Cataract operation	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Surgical and medical procedures Fistula repair	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Surgical and medical procedures Haematopoietic stem cell mobilisation	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Surgical and medical procedures Internal fixation of fracture	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Surgical and medical procedures Intra-uterine contraceptive device removal	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Surgical and medical procedures Knee arthroplasty	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Surgical and medical procedures Rehabilitation therapy	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Vascular disorders Aortic aneurysm	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Vascular disorders Aortic aneurysm rupture	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Vascular disorders Aortic dissection	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Vascular disorders Aortic dissection rupture	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Vascular disorders Aortic thrombosis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Vascular disorders Circulatory collapse	0.47% 4/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Vascular disorders Deep vein thrombosis	0.94% 8/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.3% 11/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.48% 2/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Vascular disorders Essential hypertension	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Vascular disorders Haematoma	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Vascular disorders Hypertension	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.47% 4/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Vascular disorders Hypotension	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Vascular disorders Hypovolaemic shock	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Vascular disorders Orthostatic hypotension	0.35% 3/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Vascular disorders Peripheral artery aneurysm	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Vascular disorders Peripheral ischaemia	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.48% 2/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Vascular disorders Superior vena cava syndrome	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Vascular disorders Thrombophlebitis superficial	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Vascular disorders Thrombosis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Vascular disorders Vasospasm	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Blood and lymphatic system disorders Acquired haemophilia with anti FVIII, XI, or XIII	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Blood and lymphatic system disorders Anaemia of malignant disease	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Blood and lymphatic system disorders Cytopenia	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Blood and lymphatic system disorders Platelet disorder	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Blood and lymphatic system disorders Thrombocytosis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Acute left ventricular failure	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Arrhythmia	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Cardiac tamponade	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Cardiac valve disease	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Cardiomyopathy	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Left ventricular dysfunction	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Pericardial effusion	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Cardiac disorders Ventricular arrhythmia	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Congenital, familial and genetic disorders Odontogenic cyst	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Endocrine disorders Adrenocortical insufficiency acute	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Endocrine disorders Hyperthyroidism	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Eye disorders Ulcerative keratitis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Eye disorders Vision blurred	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Anal fissure	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Appendiceal mucocoele	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Crohn's disease	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Dyspepsia	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Gastrointestinal pain	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Gingival bleeding	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Jejunal perforation	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Large intestinal haemorrhage	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Obstructive pancreatitis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Retroperitoneal mass	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Small intestinal perforation	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Toothache	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
General disorders Oedema	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.47% 2/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
General disorders Systemic inflammatory response syndrome	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Hepatobiliary disorders Bile duct obstruction	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Hepatobiliary disorders Cholecystitis chronic	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Hepatobiliary disorders Gallbladder rupture	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Hepatobiliary disorders Hepatic failure	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Hepatobiliary disorders Hepatitis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Hepatobiliary disorders Hepatotoxicity	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Hepatobiliary disorders Jaundice cholestatic	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Immune system disorders Serum sickness	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Abdominal abscess	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Abscess jaw	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Abscess neck	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Abscess soft tissue	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.48% 2/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Acute sinusitis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Bacterial parotitis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.48% 2/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Campylobacter gastroenteritis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Candida infection	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Device related sepsis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Empyema	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Endocarditis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Enterocolitis bacterial	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Epiglottitis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Gangrene	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Gastroenteritis norovirus	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Gastroenteritis salmonella	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Gastrointestinal infection	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Hepatitis B	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Herpes virus infection	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Herpes zoster cutaneous disseminated	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Infected dermal cyst	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Large intestine infection	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Meningitis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Meningitis cryptococcal	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Metapneumovirus infection	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Nasopharyngitis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Opportunistic infection	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Otitis externa	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Parvovirus B19 infection	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Pleural infection	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Pneumonia fungal	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Pneumonia haemophilus	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Pneumonia pseudomonal	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Pneumonia streptococcal	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Pseudomembranous colitis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Pulmonary sepsis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Soft tissue infection	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Urinary tract infection fungal	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Vascular device infection	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Compression fracture	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Facial bones fracture	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Incarcerated incisional hernia	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Injury	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Limb fracture	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Poisoning	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Post procedural fever	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Procedural nausea	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Pulmonary contusion	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Skin laceration	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Investigations Blood immunoglobulin A increased	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Investigations Influenza A virus test positive	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Investigations Light chain analysis abnormal	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Investigations Plasma cells increased	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Investigations Plasma cells present	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Investigations Protein urine present	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Investigations White blood cell count increased	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Metabolism and nutrition disorders Obesity	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Metabolism and nutrition disorders Steroid diabetes	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Bone lesion	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Bone swelling	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Mobility decreased	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Osteolysis	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute leukaemia	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.47% 2/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute lymphocytic leukaemia	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute lymphocytic leukaemia recurrent	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anaplastic large-cell lymphoma	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone marrow tumour cell infiltration	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma multiforme	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oropharyngeal cancer	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Spinal cord neoplasm	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Brain oedema	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Cerebral atrophy	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Cerebral haematoma	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Cerebral infarction	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Cerebrovascular disorder	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Cervical cord compression	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Dementia	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Encephalitis post varicella	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Headache	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Intracranial mass	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Myelopathy	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Parkinson's disease	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Product Issues Device dislocation	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Psychiatric disorders Adjustment disorder	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Psychiatric disorders Drug dependence	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Psychiatric disorders Organic brain syndrome	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Psychiatric disorders Psychiatric decompensation	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Renal and urinary disorders Bladder obstruction	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Renal and urinary disorders Hydronephrosis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Renal and urinary disorders Nephropathy toxic	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Renal and urinary disorders Oliguria	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Asphyxia	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Pleural disorder	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Pleural thickening	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.23% 2/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Surgical and medical procedures Autologous haematopoietic stem cell transplant	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 2/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Vascular disorders Aortic stenosis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Vascular disorders Arterial disorder	0.12% 1/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Vascular disorders Hypertensive urgency	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.12% 1/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Vascular disorders Venous thrombosis	0.00% 0/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.

Other adverse events

Measure	DB: Zoledronic Acid n=852 participants at risk Participants received zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneously once every 4 weeks (Q4W) in the double-blind (DB) treatment phase.	DB: Denosumab n=850 participants at risk Participants received denosumab 120 mg subcutaneously plus placebo to zoledronic acid intravenously once every 4 weeks (Q4W) in the double-blind (DB) treatment phase.	OL: Zoledronic Acid / Denosumab n=418 participants at risk Participants who received zoledronic acid 4 mg intravenously plus placebo to denosumab subcutaneously (SC) once every 4 weeks (Q4W) in the double-blind treatment phase received denosumab 120 mg SC Q4W in the open-label (OL) treatment phase.	OL: Denosumab / Denosumab n=426 participants at risk Participants who received denosumab 120 mg subcutaneously (SC) plus placebo to zoledronic acid intravenously once every 4 weeks (Q4W) in the double-blind treatment phase received denosumab 120 mg SC Q4W in the open-label (OL) treatment phase.
Gastrointestinal disorders Constipation	25.1% 214/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	24.4% 207/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	4.5% 19/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	6.3% 27/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Blood and lymphatic system disorders Anaemia	21.7% 185/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	24.5% 208/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	12.2% 51/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	14.6% 62/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Blood and lymphatic system disorders Febrile neutropenia	9.6% 82/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	10.5% 89/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	2.2% 9/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.47% 2/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Blood and lymphatic system disorders Neutropenia	19.5% 166/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	20.4% 173/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	9.6% 40/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	12.0% 51/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Blood and lymphatic system disorders Thrombocytopenia	17.7% 151/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	20.5% 174/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	6.5% 27/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	6.3% 27/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Abdominal pain	5.8% 49/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	9.2% 78/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	3.8% 16/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	3.1% 13/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Diarrhoea	35.3% 301/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	35.8% 304/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	17.5% 73/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	13.4% 57/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Dyspepsia	7.3% 62/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	7.1% 60/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	2.9% 12/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	2.6% 11/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Nausea	32.2% 274/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	33.4% 284/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	7.7% 32/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	8.2% 35/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Stomatitis	6.2% 53/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	7.4% 63/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.2% 5/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.9% 8/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Vomiting	18.7% 159/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	17.3% 147/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	4.3% 18/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	4.5% 19/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
General disorders Asthenia	15.0% 128/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	13.2% 112/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	6.2% 26/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	4.2% 18/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
General disorders Fatigue	25.2% 215/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	24.2% 206/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	10.3% 43/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	8.9% 38/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
General disorders Mucosal inflammation	6.5% 55/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	8.9% 76/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.2% 5/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.70% 3/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
General disorders Oedema peripheral	17.3% 147/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	17.9% 152/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	6.9% 29/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	3.3% 14/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
General disorders Pyrexia	24.6% 210/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	21.4% 182/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	7.2% 30/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	10.3% 44/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Bronchitis	8.5% 72/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	8.5% 72/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	7.4% 31/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	7.5% 32/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Herpes zoster	8.0% 68/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	7.3% 62/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	3.1% 13/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.2% 5/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Nasopharyngitis	9.3% 79/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	9.9% 84/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	10.0% 42/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	8.9% 38/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Respiratory tract infection	6.2% 53/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	6.6% 56/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	6.0% 25/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	6.1% 26/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Upper respiratory tract infection	14.9% 127/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	16.8% 143/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	14.8% 62/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	13.6% 58/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Urinary tract infection	6.0% 51/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	7.4% 63/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	4.1% 17/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	4.5% 19/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Lumbar vertebral fracture	8.5% 72/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	8.2% 70/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.24% 1/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Rib fracture	8.2% 70/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	8.1% 69/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.48% 2/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.70% 3/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Injury, poisoning and procedural complications Thoracic vertebral fracture	8.8% 75/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	11.2% 95/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.23% 1/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Investigations Blood creatinine increased	9.4% 80/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	4.2% 36/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	3.6% 15/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	2.1% 9/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Investigations Platelet count decreased	6.5% 55/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	6.5% 55/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	2.4% 10/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	3.3% 14/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Investigations Weight decreased	7.2% 61/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	7.2% 61/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	2.9% 12/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	2.1% 9/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Metabolism and nutrition disorders Decreased appetite	19.5% 166/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	16.5% 140/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	2.9% 12/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	2.8% 12/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Metabolism and nutrition disorders Hypocalcaemia	11.6% 99/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	16.6% 141/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	6.5% 27/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	7.0% 30/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Metabolism and nutrition disorders Hypokalaemia	16.4% 140/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	15.2% 129/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	6.2% 26/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	6.1% 26/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Metabolism and nutrition disorders Hypomagnesaemia	6.1% 52/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	4.6% 39/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.7% 7/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	2.1% 9/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Metabolism and nutrition disorders Hypophosphataemia	5.6% 48/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	6.9% 59/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	3.6% 15/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	2.8% 12/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Arthralgia	13.8% 118/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	15.4% 131/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	10.5% 44/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	8.5% 36/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Back pain	21.2% 181/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	22.8% 194/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	11.0% 46/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	13.1% 56/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Bone pain	12.3% 105/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	11.6% 99/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	3.8% 16/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	3.1% 13/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Muscle spasms	5.9% 50/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	7.4% 63/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	6.7% 28/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	6.3% 27/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	9.6% 82/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	8.5% 72/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	4.8% 20/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	5.4% 23/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Myalgia	6.5% 55/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	5.9% 50/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	3.6% 15/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.4% 6/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Pain in extremity	16.2% 138/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	14.9% 127/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	6.9% 29/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	6.6% 28/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Dizziness	11.0% 94/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	10.8% 92/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	4.5% 19/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	3.3% 14/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Headache	10.3% 88/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	11.8% 100/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	2.9% 12/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	4.5% 19/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Hypoaesthesia	5.5% 47/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	6.1% 52/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	2.6% 11/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	2.1% 9/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Neuropathy peripheral	17.3% 147/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	15.8% 134/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	4.1% 17/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	3.3% 14/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Paraesthesia	8.6% 73/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	8.2% 70/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	2.9% 12/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	2.6% 11/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Nervous system disorders Peripheral sensory neuropathy	8.6% 73/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	9.4% 80/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	2.9% 12/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.2% 5/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Psychiatric disorders Anxiety	8.5% 72/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	7.2% 61/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.96% 4/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.6% 7/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Psychiatric disorders Depression	7.7% 66/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	5.5% 47/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.96% 4/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.9% 8/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Psychiatric disorders Insomnia	15.8% 135/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	15.5% 132/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	4.8% 20/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	3.5% 15/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Cough	20.0% 170/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	18.7% 159/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	12.2% 51/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	11.0% 47/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Dyspnoea	11.3% 96/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	9.8% 83/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	5.3% 22/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	5.9% 25/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.4% 46/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	7.6% 65/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	3.1% 13/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	2.8% 12/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Skin and subcutaneous tissue disorders Alopecia	5.6% 48/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	6.6% 56/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.00% 0/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	0.94% 4/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Skin and subcutaneous tissue disorders Pruritus	6.0% 51/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	6.4% 54/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.4% 6/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	2.8% 12/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Skin and subcutaneous tissue disorders Rash	12.0% 102/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	15.5% 132/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	4.1% 17/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	4.0% 17/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Vascular disorders Hypertension	8.2% 70/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	7.4% 63/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	3.1% 13/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	3.8% 16/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Vascular disorders Hypotension	4.6% 39/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	5.9% 50/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.4% 6/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.6% 7/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Blood and lymphatic system disorders Leukopenia	4.8% 41/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	5.5% 47/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	2.4% 10/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	2.3% 10/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Abdominal pain upper	5.2% 44/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	4.9% 42/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	2.2% 9/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.4% 6/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Gastrointestinal disorders Toothache	5.3% 45/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	5.9% 50/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	6.5% 27/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	3.8% 16/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
General disorders Pain	4.6% 39/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	5.3% 45/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.2% 5/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	3.8% 16/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Influenza	3.9% 33/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	3.1% 26/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	5.5% 23/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	5.4% 23/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Infections and infestations Pneumonia	5.9% 50/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	4.8% 41/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	4.8% 20/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	3.1% 13/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	5.2% 44/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	4.9% 42/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	1.7% 7/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	3.1% 13/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	2.8% 24/852 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	4.5% 38/850 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	5.3% 22/418 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.	8.5% 36/426 • DB (double-blind treatment phase): adverse events (AEs) were from 1st dose of study drug to the later of 30 days after last dose or end of treatment phase. OL (open-label treatment phase): AEs were from 1st dose of OL study drug to end of study. Median months on study drug: 18.4 (zoledronic acid [ZA]) and 19.4 (Denosumab [Dmab]) in DB; 23.2 (ZA/Dmab) and 23.0 (Dmab/Dmab) in OL.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: medinfo@amgen.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER