Trial Outcomes & Findings for A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis (NCT NCT02016716)

NCT ID: NCT02016716

Last Updated: 2018-11-08

Results Overview

Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

294 participants

Primary outcome timeframe

Baseline and month 6

Results posted on

2018-11-08

Participant Flow

This study was conducted at 11 centers: 7 in Poland, 2 in the Czech Republic, and 2 in the United States. The first participant enrolled on 03 December 2013 and the last participant enrolled on 07 March 2014.

Eligible participants were randomized in a 22:5:22:5 ratio to receive * romosozumab 90 mg/mL * placebo 90 mg/mL * romosozumab 70 mg/mL * placebo 70 mg/mL For efficacy analyses the 2 placebo groups were combined, for safety analyses the data were reported separately.

Participant milestones

Participant milestones
Measure	Placebo Participants received matching placebo (either administered as 2 subcutaneous (SC) injections of 1.17 mL or 3 SC injections of 1.0 mL) every month for 6 months.	Romosozumab 70 mg/mL Participants received 210 mg romosozumab monthly, administered as 3 subcutaneous 1 mL injections of a 70 mg/mL solution, for 6 months.	Romosozumab 90 mg/mL Participants received 210 mg romosozumab monthly, administered as 2 subcutaneous 1.17 mL injections of a 90 mg/mL solution, for 6 months.
Overall Study STARTED	53	118	123
Overall Study Received Study Treatment	53	118	123
Overall Study COMPLETED	47	110	117
Overall Study NOT COMPLETED	6	8	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received matching placebo (either administered as 2 subcutaneous (SC) injections of 1.17 mL or 3 SC injections of 1.0 mL) every month for 6 months.	Romosozumab 70 mg/mL Participants received 210 mg romosozumab monthly, administered as 3 subcutaneous 1 mL injections of a 70 mg/mL solution, for 6 months.	Romosozumab 90 mg/mL Participants received 210 mg romosozumab monthly, administered as 2 subcutaneous 1.17 mL injections of a 90 mg/mL solution, for 6 months.
Overall Study Withdrawal by Subject	5	5	5
Overall Study Protocol-specified Criteria	0	1	0
Overall Study Lost to Follow-up	1	2	1

Baseline Characteristics

Participants with available data

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=53 Participants Participants received matching placebo (either administered as 2 subcutaneous (SC) injections of 1.17 mL or 3 SC injections of 1.0 mL) every month for 6 months.	Romosozumab 70 mg/mL n=118 Participants Participants received 210 mg romosozumab monthly, administered as 3 subcutaneous 1 mL injections of a 70 mg/mL solution, for 6 months.	Romosozumab 90 mg/mL n=123 Participants Participants received 210 mg romosozumab monthly, administered as 2 subcutaneous 1.17 mL injections of a 90 mg/mL solution, for 6 months.	Total n=294 Participants Total of all reporting groups
Age, Continuous	68.4 years STANDARD_DEVIATION 8.0 • n=53 Participants	67.4 years STANDARD_DEVIATION 7.1 • n=118 Participants	67.7 years STANDARD_DEVIATION 7.6 • n=123 Participants	67.7 years STANDARD_DEVIATION 7.5 • n=294 Participants
Age, Customized < 65 years	23 Participants n=53 Participants	46 Participants n=118 Participants	46 Participants n=123 Participants	115 Participants n=294 Participants
Age, Customized ≥ 65 years	30 Participants n=53 Participants	72 Participants n=118 Participants	77 Participants n=123 Participants	179 Participants n=294 Participants
Sex: Female, Male Female	53 Participants n=53 Participants	118 Participants n=118 Participants	123 Participants n=123 Participants	294 Participants n=294 Participants
Sex: Female, Male Male	0 Participants n=53 Participants	0 Participants n=118 Participants	0 Participants n=123 Participants	0 Participants n=294 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=53 Participants	6 Participants n=118 Participants	9 Participants n=123 Participants	17 Participants n=294 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	51 Participants n=53 Participants	112 Participants n=118 Participants	114 Participants n=123 Participants	277 Participants n=294 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=53 Participants	0 Participants n=118 Participants	0 Participants n=123 Participants	0 Participants n=294 Participants
Race/Ethnicity, Customized Asian	0 Participants n=53 Participants	2 Participants n=118 Participants	0 Participants n=123 Participants	2 Participants n=294 Participants
Race/Ethnicity, Customized Black (or African American)	0 Participants n=53 Participants	1 Participants n=118 Participants	0 Participants n=123 Participants	1 Participants n=294 Participants
Race/Ethnicity, Customized White	53 Participants n=53 Participants	115 Participants n=118 Participants	123 Participants n=123 Participants	291 Participants n=294 Participants
Lumbar Spine Bone Mineral Density (BMD) T-score	-2.842 T-score STANDARD_DEVIATION 1.033 • n=53 Participants	-2.965 T-score STANDARD_DEVIATION 0.960 • n=118 Participants	-3.029 T-score STANDARD_DEVIATION 0.687 • n=123 Participants	-2.970 T-score STANDARD_DEVIATION 0.871 • n=294 Participants
Total Hip BMD T-score	-2.057 T-score STANDARD_DEVIATION 0.634 • n=53 Participants	-1.819 T-score STANDARD_DEVIATION 0.673 • n=118 Participants	-1.828 T-score STANDARD_DEVIATION 0.649 • n=123 Participants	-1.866 T-score STANDARD_DEVIATION 0.660 • n=294 Participants
Femoral Neck BMD T-score	-2.304 T-score STANDARD_DEVIATION 0.517 • n=53 Participants	-2.139 T-score STANDARD_DEVIATION 0.611 • n=118 Participants	-2.018 T-score STANDARD_DEVIATION 0.593 • n=123 Participants	-2.118 T-score STANDARD_DEVIATION 0.595 • n=294 Participants
Serum Procollagen Type 1 N-telopeptide (P1NP)	49.0 μg/L n=53 Participants • Participants with available data	53.0 μg/L n=117 Participants • Participants with available data	50.0 μg/L n=123 Participants • Participants with available data	51.0 μg/L n=293 Participants • Participants with available data
Serum Type 1 Collagen C-telopeptide (CTX)	426.5 ng/L n=52 Participants • Participants with available data	440.0 ng/L n=117 Participants • Participants with available data	402.0 ng/L n=123 Participants • Participants with available data	426.0 ng/L n=292 Participants • Participants with available data

PRIMARY outcome

Timeframe: Baseline and month 6

Population: All randomized participants who had a baseline and a month 6 lumbar spine DXA BMD measurement

Bone mineral density was measured by dual-energy X-ray absorptiometry (DXA).

Outcome measures

Outcome measures
Measure	Placebo n=46 Participants Participants received matching placebo (either administered as 2 subcutaneous (SC) injections of 1.17 mL or 3 SC injections of 1.0 mL) every month for 6 months.	Romosozumab 70 mg/mL n=110 Participants Participants received 210 mg romosozumab monthly, administered as 3 subcutaneous 1 mL injections of a 70 mg/mL solution, for 6 months.	Romosozumab 90 mg/mL n=117 Participants Participants received 210 mg romosozumab monthly, administered as 2 subcutaneous 1.17 mL injections of a 90 mg/mL solution, for 6 months.
Percent Change From Baseline in Bone Mineral Density (BMD) at the Lumbar Spine	0.8 percent change Interval -0.4 to 2.1	9.6 percent change Interval 8.8 to 10.4	9.2 percent change Interval 8.4 to 10.0

SECONDARY outcome

Timeframe: Baseline and month 6

Population: All randomized participants who had a baseline and month 6 hip DXA BMD measurement.

Total hip BMD was measured using DXA. The analysis was based on an ANCOVA model adjusted for treatment and baseline total hip BMD T-score.

Outcome measures

Outcome measures
Measure	Placebo n=46 Participants Participants received matching placebo (either administered as 2 subcutaneous (SC) injections of 1.17 mL or 3 SC injections of 1.0 mL) every month for 6 months.	Romosozumab 70 mg/mL n=110 Participants Participants received 210 mg romosozumab monthly, administered as 3 subcutaneous 1 mL injections of a 70 mg/mL solution, for 6 months.	Romosozumab 90 mg/mL n=116 Participants Participants received 210 mg romosozumab monthly, administered as 2 subcutaneous 1.17 mL injections of a 90 mg/mL solution, for 6 months.
Percent Change From Baseline in Total Hip BMD	-0.0 percent change Interval -0.9 to 0.8	3.9 percent change Interval 3.4 to 4.4	3.4 percent change Interval 2.9 to 4.0

SECONDARY outcome

Timeframe: Baseline and month 6

Population: All randomized participants who had a baseline and month 6 femoral neck DXA BMD measurement.

Femoral neck BMD was measured using DXA. The analysis was based on an ANCOVA model adjusted for treatment and baseline femoral neck BMD T-score.

Outcome measures

Outcome measures
Measure	Placebo n=46 Participants Participants received matching placebo (either administered as 2 subcutaneous (SC) injections of 1.17 mL or 3 SC injections of 1.0 mL) every month for 6 months.	Romosozumab 70 mg/mL n=110 Participants Participants received 210 mg romosozumab monthly, administered as 3 subcutaneous 1 mL injections of a 70 mg/mL solution, for 6 months.	Romosozumab 90 mg/mL n=116 Participants Participants received 210 mg romosozumab monthly, administered as 2 subcutaneous 1.17 mL injections of a 90 mg/mL solution, for 6 months.
Percent Change From Baseline in Femoral Neck BMD	-0.5 percent change Interval -1.5 to 0.5	3.1 percent change Interval 2.5 to 3.8	2.6 percent change Interval 2.0 to 3.3

SECONDARY outcome

Timeframe: Baseline, month 1, month 3, and month 6

Population: All randomized participants who had a baseline and at least one postbaseline measurement for P1NP, and with available data at each time point.

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Participants received matching placebo (either administered as 2 subcutaneous (SC) injections of 1.17 mL or 3 SC injections of 1.0 mL) every month for 6 months.	Romosozumab 70 mg/mL n=115 Participants Participants received 210 mg romosozumab monthly, administered as 3 subcutaneous 1 mL injections of a 70 mg/mL solution, for 6 months.	Romosozumab 90 mg/mL n=120 Participants Participants received 210 mg romosozumab monthly, administered as 2 subcutaneous 1.17 mL injections of a 90 mg/mL solution, for 6 months.
Percent Change From Baseline in N-Terminal Propeptide Type 1 Procollagen (P1NP) Month 1	2.000 percent change Interval -5.797 to 16.129	96.296 percent change Interval 67.143 to 159.341	97.435 percent change Interval 69.259 to 126.179
Percent Change From Baseline in N-Terminal Propeptide Type 1 Procollagen (P1NP) Month 3	-9.601 percent change Interval -21.503 to 2.922	23.960 percent change Interval -1.587 to 46.667	16.216 percent change Interval -10.39 to 50.0
Percent Change From Baseline in N-Terminal Propeptide Type 1 Procollagen (P1NP) Month 6	-12.500 percent change Interval -27.5 to 14.286	-2.885 percent change Interval -28.07 to 18.421	-3.604 percent change Interval -22.222 to 27.273

SECONDARY outcome

Timeframe: Baseline, month 1, month 3, and month 6

Population: All randomized participants who had a baseline and at least one postbaseline measurement for CTX and with available data at each time point.

Outcome measures

Outcome measures
Measure	Placebo n=51 Participants Participants received matching placebo (either administered as 2 subcutaneous (SC) injections of 1.17 mL or 3 SC injections of 1.0 mL) every month for 6 months.	Romosozumab 70 mg/mL n=115 Participants Participants received 210 mg romosozumab monthly, administered as 3 subcutaneous 1 mL injections of a 70 mg/mL solution, for 6 months.	Romosozumab 90 mg/mL n=120 Participants Participants received 210 mg romosozumab monthly, administered as 2 subcutaneous 1.17 mL injections of a 90 mg/mL solution, for 6 months.
Percent Change From Baseline in Serum C-Telopeptide (CTX) Month 1	0.282 percent change Interval -16.183 to 12.874	-23.158 percent change Interval -42.943 to -9.967	-21.456 percent change Interval -35.602 to -7.246
Percent Change From Baseline in Serum C-Telopeptide (CTX) Month 3	-5.687 percent change Interval -20.666 to 15.566	-11.219 percent change Interval -35.206 to 9.484	-5.473 percent change Interval -24.139 to 26.386
Percent Change From Baseline in Serum C-Telopeptide (CTX) Month 6	-8.120 percent change Interval -26.935 to 10.059	-25.780 percent change Interval -43.573 to -8.216	-17.305 percent change Interval -37.566 to 6.405

Adverse Events

Placebo 70 mg

Serious events: 4 serious events

Other events: 9 other events

Deaths: 0 deaths

Placebo 90 mg/mL

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Romosozumab 70 mg/mL

Serious events: 7 serious events

Other events: 24 other events

Deaths: 0 deaths

Romosozumab 90 mg/mL

Serious events: 3 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Placebo 70 mg n=26 participants at risk Participants received matching placebo administered as 3 subcutaneous injections of 1.0 mL every month for 6 months.	Placebo 90 mg/mL n=26 participants at risk Participants received matching placebo administered as 2 subcutaneous injections of 1.17 mL every month for 6 months.	Romosozumab 70 mg/mL n=119 participants at risk Participants received 210 mg romosozumab monthly, administered as 3 subcutaneous 1 mL injections of a 70 mg/mL solution, for 6 months.	Romosozumab 90 mg/mL n=123 participants at risk Participants received 210 mg romosozumab monthly, administered as 2 subcutaneous 1.17 mL injections of a 90 mg/mL solution, for 6 months.
General disorders Asthenia	0.00% 0/26 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.7% 2/26 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.4% 4/119 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.3% 4/123 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Injection site erythema	0.00% 0/26 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/26 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.7% 2/119 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.7% 7/123 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
General disorders Injection site pain	0.00% 0/26 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/26 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.9% 7/119 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	2.4% 3/123 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Nasopharyngitis	11.5% 3/26 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/26 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.6% 9/119 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	15.4% 19/123 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Upper respiratory tract infection	3.8% 1/26 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.7% 2/26 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.84% 1/119 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.6% 2/123 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Infections and infestations Urinary tract infection	0.00% 0/26 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	3.8% 1/26 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.84% 1/119 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	5.7% 7/123 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Injury, poisoning and procedural complications Fall	7.7% 2/26 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/26 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.7% 2/119 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.6% 2/123 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/26 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	7.7% 2/26 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.7% 2/119 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.6% 2/123 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Nervous system disorders Headache	11.5% 3/26 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	0.00% 0/26 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.7% 2/119 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.	1.6% 2/123 • Adverse events are reported from the first dose of study drug until 90 days after last dose (9 months overall). One participant was randomized to the placebo group but incorrectly received 1 dose of romosozumab 70 mg/mL and was included in the romosozumab 70 mg/mL group for analysis of adverse events. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

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