Trial Outcomes & Findings for Efficacy and Safety of Intravenous Neridronic Acid in Complex Regional Pain Syndrome (CRPS) (NCT NCT03560986)

NCT ID: NCT03560986

Last Updated: 2020-08-05

Results Overview

In the Baseline Phase and in Treatment Period A/Follow-up Period 1, participants were asked to assessed their average CRPS-related pain on an 11-point numerical rating scale (NRS) - from 0 = "no pain" to 10 = "pain as bad as you can imagine" and report it once daily (in the evening, 24-hour recall) in an electronic diary. Changes from baseline (average for the Baseline Phase) to the weekly average for Week 12 were calculated.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 267 participants
• Primary outcome timeframe: From the Baseline Phase (Day -7 to Day -1) to Week 12
• Results posted on: 2020-08-05

Participant Flow

First participant enrollment on 31 May 2018. After a pooled interim analysis of primary endpoint data of studies KF7013-04 and KF7013-02 (NCT03530345), recruitment was stopped as interim results indicated futility. Last participant's last assessment was on 01 Aug 2019.

267 participants were enrolled (signed consent), 100 were allocated to treatment, and 99 received study medication. Of 167 participants not allocated, 99 did not meet inclusion/met exclusion criteria, 3 were lost to follow-up, 14 withdrew consent, 1 experienced adverse events, and 50 were not allocated for other reasons (study termination).

Participant milestones

Measure	Neridronic Acid - Treatment Period A * Treatment Period A: Neridronic acid 100 mg - 4 intravenous infusions within 10 days; Follow-up Period 1 until 26 weeks. * Treatment Period B: Neridronic acid 100 mg - 4 intravenous infusions within 10 days; Follow-up Period 2 until 52 weeks.	Placebo - Treatment Period A * Treatment Period A: Matching placebo - 4 intravenous infusions within 10 days; Follow-up Period 1 until 26 weeks. * Treatment Period B: Neridronic acid 100 mg - 4 intravenous infusions within 10 days; Follow-up Period 2 until 52 weeks.
Treatment Period A/Follow-up Period 1 STARTED	48	51
Treatment Period A/Follow-up Period 1 Treatment Period A Completers	45	45
Treatment Period A/Follow-up Period 1 COMPLETED	12	13
Treatment Period A/Follow-up Period 1 NOT COMPLETED	36	38
Treatment Period B/Follow-up Period 2 STARTED	9	8
Treatment Period B/Follow-up Period 2 Treatment Period B Completers	8	8
Treatment Period B/Follow-up Period 2 COMPLETED	1	0
Treatment Period B/Follow-up Period 2 NOT COMPLETED	8	8

Reasons for withdrawal

Measure	Neridronic Acid - Treatment Period A * Treatment Period A: Neridronic acid 100 mg - 4 intravenous infusions within 10 days; Follow-up Period 1 until 26 weeks. * Treatment Period B: Neridronic acid 100 mg - 4 intravenous infusions within 10 days; Follow-up Period 2 until 52 weeks.	Placebo - Treatment Period A * Treatment Period A: Matching placebo - 4 intravenous infusions within 10 days; Follow-up Period 1 until 26 weeks. * Treatment Period B: Neridronic acid 100 mg - 4 intravenous infusions within 10 days; Follow-up Period 2 until 52 weeks.
Treatment Period A/Follow-up Period 1 Withdrawal by Subject	3	1
Treatment Period A/Follow-up Period 1 Lost to Follow-up	1	1
Treatment Period A/Follow-up Period 1 Protocol Violation	0	1
Treatment Period A/Follow-up Period 1 Disc. before end of Follow-up Period 1	32	35
Treatment Period B/Follow-up Period 2 Adverse Event	1	0
Treatment Period B/Follow-up Period 2 Withdrawal by Subject	0	1
Treatment Period B/Follow-up Period 2 Disc. before end of Follow-up Period 2	7	7

Baseline Characteristics

Efficacy and Safety of Intravenous Neridronic Acid in Complex Regional Pain Syndrome (CRPS)

Baseline characteristics by cohort

Measure	Neridronic Acid - Treatment Period A n=48 Participants Neridronic acid 400 mg administered by 4 intravenous infusions within 10 Days in Treatment Period A.	Placebo - Treatment Period A n=51 Participants Matching placebo administered by 4 intravenous infusions within 10 Days in Treatment Period A.	Total n=99 Participants Total of all reporting groups
Age, Continuous	49.5 years STANDARD_DEVIATION 12.7 • n=5 Participants	50.4 years STANDARD_DEVIATION 12.6 • n=7 Participants	50.0 years STANDARD_DEVIATION 12.6 • n=5 Participants
Age, Customized <18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized From 18 to <65 years	42 Participants n=5 Participants	46 Participants n=7 Participants	88 Participants n=5 Participants
Age, Customized From 65 to <85 years	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Age, Customized 85 years and above	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	36 Participants n=7 Participants	71 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	42 Participants n=5 Participants	44 Participants n=7 Participants	86 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Canada	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	37 Participants n=5 Participants	36 Participants n=7 Participants	73 Participants n=5 Participants
Region of Enrollment Czechia	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United Kingdom	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment Slovakia	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
CRPS type CRPS Type I	38 Participants n=5 Participants	33 Participants n=7 Participants	71 Participants n=5 Participants
CRPS type CRPS Type II	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
CRPS type Unknown CRPS Type	5 Participants n=5 Participants	9 Participants n=7 Participants	14 Participants n=5 Participants
Time since onset of CRPS symptoms	12.88 months n=5 Participants	11.80 months n=7 Participants	12.33 months n=5 Participants
Time since diagnosis of CRPS	5.92 months n=5 Participants	5.83 months n=7 Participants	5.83 months n=5 Participants

PRIMARY outcome

Timeframe: From the Baseline Phase (Day -7 to Day -1) to Week 12

Population: Full Analysis Set; all participants treated in Treatment Period A with all data available at the time of last participant out following premature study termination.

In the Baseline Phase and in Treatment Period A/Follow-up Period 1, participants were asked to assessed their average CRPS-related pain on an 11-point numerical rating scale (NRS) - from 0 = "no pain" to 10 = "pain as bad as you can imagine" and report it once daily (in the evening, 24-hour recall) in an electronic diary.

Changes from baseline (average for the Baseline Phase) to the weekly average for Week 12 were calculated.

Outcome measures

Measure	Neridronic Acid - Treatment Period A n=48 Participants Neridronic acid 100 mg - 4 intravenous infusions within 10 Days	Placebo - Treatment Period A n=51 Participants Matching placebo - 4 intravenous infusions within 10 Days
Change From Baseline to Week 12 in the Average Pain Intensity Score (Weekly Average of Pain Values Recorded Daily in the Electronic Diary)	-1.28 units on a scale Standard Error 0.270	-1.71 units on a scale Standard Error 0.268

SECONDARY outcome

Timeframe: From baseline (Visit 2 [Day 1]) to Visit 11 (Week 26)

Population: Data were not collected or analyzed because a confirmatory testing strategy was not performed as pre-specified in the protocol that secondary endpoints would only be tested if neridronic acid was superior to placebo on the primary outcome measure. A confirmatory or descriptive analysis was not performed due to early study termination.

11-point NRS - from 0 = "no pain" to 10 = "pain as bad as you can imagine" - reported at the visits on a tablet computer (24-hour recall). Changes from baseline to Week 26 were planned to be analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline (Visit 2 [Day 1]) to Visit 8 (Week 12)

Population: Data were not collected or analyzed because a confirmatory testing strategy was not performed as pre-specified in the protocol that secondary endpoints would only be tested if neridronic acid was superior to placebo on the primary outcome measure. A confirmatory or descriptive analysis was not performed due to early study termination.

11-point NRS - from 0 = "no pain" to 10 = "pain as bad as you can imagine" - reported at the visits on a tablet computer (24-hour recall).

The number of participants with response at Week 12 was planned to be determined.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline (Visit 2 [Day 1]) to Visit 11 (Week 26)

Population: Data were not collected or analyzed because a confirmatory testing strategy was not performed as pre-specified in the protocol that secondary endpoints would only be tested if neridronic acid was superior to placebo on the primary outcome measure. A confirmatory or descriptive analysis was not performed due to early study termination.

11-point NRS - from 0 = "no pain" to 10 = "pain as bad as you can imagine" - reported at the visits on a tablet computer (24-hour recall). The number of participants with response at Week 26 was planned to be determined.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline (Visit 2 [Day 1]) to Visit 8 (Week 12)

Population: Data were not collected or analyzed because a confirmatory testing strategy was not performed as pre-specified in the protocol that secondary endpoints would only be tested if neridronic acid was superior to placebo on the primary outcome measure. A confirmatory or descriptive analysis was not performed due to early study termination.

Dynamic mechanical allodynia: a tactile stimulus is applied in a single sweeping motion (1 cm to 2 cm length) on the skin on the affected limb. The participants are asked to judge the stimulus intensity by means of an NRS (0 to 10). "0" in this case means "no pain". Each "pricking", "stinging" or "burning" sensation is defined as a painful sensation, which should always be evaluated by giving a value greater than "0". "10" corresponds to the individual maximum pain imaginable. Change from baseline was planned to analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline (Visit 2 [Day 1]) to Visit 8 (Week 12)

Population: Data were not collected or analyzed because a confirmatory testing strategy was not performed as pre-specified in the protocol that secondary endpoints would only be tested if neridronic acid was superior to placebo on the primary outcome measure. A confirmatory or descriptive analysis was not performed due to early study termination.

Pressure pain threshold: using a pressure algometer (contact area 1 cm2), the threshold for pressure-induced pain is measured on the thenar muscle/abductor hallucis muscle in 3 series of slowly increasing stimulus intensities (at a rate of about 50 kPa/s). The threshold is then determined as the arithmetic mean of the 3 series (in kPa).

The ratio of the thresholds of the affected limb versus the unaffected limb was planned to be calculated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From baseline (Visit 2 [Day 1]) to Visit 8 (Week 12)

Population: Data were not collected or analyzed because a confirmatory testing strategy was not performed as pre-specified in the protocol that secondary endpoints would only be tested if neridronic acid was superior to placebo on the primary outcome measure. A confirmatory or descriptive analysis was not performed due to early study termination.

In participants with the CRPS sign of edema on the CRPS severity score at baseline, circumference of the hand or foot will be measured by the investigator with measurement tape using the figure-of-eight method at both the affected limb and the contralateral unaffected limb. Each measurement will be performed 3 times. The average of the 3 measurements will be used for further analysis.

The ratio of the averages of the affected limb versus the unaffected limb was planned to be calculated and used for the determination of the change from baseline.

Outcome measures

Outcome data not reported

Adverse Events

Baseline to Week 26: Placebo TPA

Serious events: 3 serious events

Other events: 40 other events

Deaths: 0 deaths

Baseline to Week 26: Neridronic Acid TPA

Serious events: 2 serious events

Other events: 40 other events

Deaths: 0 deaths

Week 26 to Week 52: Placebo TPA

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Week 26 to Week 52: Placebo TPA, Neridronic Acid TPB

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Week 26 to Week 52: Neridronic Acid TPA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Week 26 to Week 52: Neridronic Acid TPA, Neridronic Acid TPB

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Baseline to Week 26: Placebo TPA n=51 participants at risk In Treatment Period A, participants received matching placebo - 4 intravenous infusions within 10 Days; Follow-up Period 1 until 26 weeks.	Baseline to Week 26: Neridronic Acid TPA n=48 participants at risk In Treatment Period A, participants received neridronic acid 100 mg - 4 intravenous infusions within 10 days; Follow-up Period 1 until 26 weeks.	Week 26 to Week 52: Placebo TPA n=43 participants at risk Participants with placebo treatment in Treatment Period A/Follow-up Period 1 were followed up without administration of study medication until 52 weeks in Follow-up Period 2.	Week 26 to Week 52: Placebo TPA, Neridronic Acid TPB n=8 participants at risk Participants who had completed treatment with placebo in Treatment Period A/Follow-up Period 1 received neridronic acid treatment (100 mg - 4 intravenous infusions within 10 days) in Treatment Period B/Follow-up Period 2 until 52 weeks.	Week 26 to Week 52: Neridronic Acid TPA n=39 participants at risk Participants who had completed treatment with neridronic acid treatment in Treatment Period A/Follow-up Period 1 were followed up without administration of study medication until 52 weeks in Follow-up Period 2.	Week 26 to Week 52: Neridronic Acid TPA, Neridronic Acid TPB n=9 participants at risk Participants who had completed treatment with neridronic acid in Treatment Period A/Follow-up Period 1 received re-treatment with neridronic acid 100 mg - 4 intravenous infusions within 10 days; Follow-up Period 2 until 52 weeks.
Renal and urinary disorders Nephrolithiasis	0.00% 0/51 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	2.1% 1/48 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Cardiac disorders Silent myocardial infarction	0.00% 0/51 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	2.1% 1/48 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Infections and infestations Urinary tract infection	0.00% 0/51 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	2.1% 1/48 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	11.1% 1/9 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Metabolism and nutrition disorders Decreased appetite	2.0% 1/51 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/48 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Nervous system disorders Dysaesthesia	2.0% 1/51 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/48 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Injury, poisoning and procedural complications Overdose	2.0% 1/51 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/48 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Eye disorders Retinal detachment	2.0% 1/51 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/48 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Injury, poisoning and procedural complications Fall	0.00% 0/51 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/48 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	12.5% 1/8 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).

Other adverse events

Measure	Baseline to Week 26: Placebo TPA n=51 participants at risk In Treatment Period A, participants received matching placebo - 4 intravenous infusions within 10 Days; Follow-up Period 1 until 26 weeks.	Baseline to Week 26: Neridronic Acid TPA n=48 participants at risk In Treatment Period A, participants received neridronic acid 100 mg - 4 intravenous infusions within 10 days; Follow-up Period 1 until 26 weeks.	Week 26 to Week 52: Placebo TPA n=43 participants at risk Participants with placebo treatment in Treatment Period A/Follow-up Period 1 were followed up without administration of study medication until 52 weeks in Follow-up Period 2.	Week 26 to Week 52: Placebo TPA, Neridronic Acid TPB n=8 participants at risk Participants who had completed treatment with placebo in Treatment Period A/Follow-up Period 1 received neridronic acid treatment (100 mg - 4 intravenous infusions within 10 days) in Treatment Period B/Follow-up Period 2 until 52 weeks.	Week 26 to Week 52: Neridronic Acid TPA n=39 participants at risk Participants who had completed treatment with neridronic acid treatment in Treatment Period A/Follow-up Period 1 were followed up without administration of study medication until 52 weeks in Follow-up Period 2.	Week 26 to Week 52: Neridronic Acid TPA, Neridronic Acid TPB n=9 participants at risk Participants who had completed treatment with neridronic acid in Treatment Period A/Follow-up Period 1 received re-treatment with neridronic acid 100 mg - 4 intravenous infusions within 10 days; Follow-up Period 2 until 52 weeks.
Gastrointestinal disorders Diarrhoea	3.9% 2/51 • Number of events 2 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	4.2% 2/48 • Number of events 2 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	12.5% 1/8 • Number of events 2 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Gastrointestinal disorders Nausea	15.7% 8/51 • Number of events 12 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	4.2% 2/48 • Number of events 2 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	25.0% 2/8 • Number of events 5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	11.1% 1/9 • Number of events 4 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Gastrointestinal disorders Vomiting	3.9% 2/51 • Number of events 2 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/48 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	12.5% 1/8 • Number of events 3 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
General disorders Acute phase reaction	9.8% 5/51 • Number of events 6 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	16.7% 8/48 • Number of events 10 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	25.0% 2/8 • Number of events 9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
General disorders Fatigue	2.0% 1/51 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	6.2% 3/48 • Number of events 3 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
General disorders Influenza like illness	0.00% 0/51 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	8.3% 4/48 • Number of events 4 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
General disorders Oedema peripheral	0.00% 0/51 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	4.2% 2/48 • Number of events 2 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
General disorders Pain	2.0% 1/51 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	6.2% 3/48 • Number of events 3 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
General disorders Pyrexia	3.9% 2/51 • Number of events 2 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	2.1% 1/48 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Infections and infestations Laryngitis	3.9% 2/51 • Number of events 2 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/48 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Infections and infestations Nasopharyngitis	3.9% 2/51 • Number of events 2 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	4.2% 2/48 • Number of events 2 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	11.1% 1/9 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Infections and infestations Sinusitis	0.00% 0/51 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	4.2% 2/48 • Number of events 2 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Infections and infestations Urinary tract infection	2.0% 1/51 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	8.3% 4/48 • Number of events 4 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	11.1% 1/9 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Infections and infestations Viral upper respiratory tract infection	2.0% 1/51 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	4.2% 2/48 • Number of events 2 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Investigations Lipase increased	2.0% 1/51 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	6.2% 3/48 • Number of events 3 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Investigations Urine albumin/creatinine ratio increased	2.0% 1/51 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	10.4% 5/48 • Number of events 5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Metabolism and nutrition disorders Hyperglycaemia	3.9% 2/51 • Number of events 4 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	2.1% 1/48 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	12.5% 1/8 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Metabolism and nutrition disorders Vitamin D deficiency	9.8% 5/51 • Number of events 5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	6.2% 3/48 • Number of events 3 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Musculoskeletal and connective tissue disorders Arthralgia	5.9% 3/51 • Number of events 3 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	6.2% 3/48 • Number of events 3 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	12.5% 1/8 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	11.1% 1/9 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Musculoskeletal and connective tissue disorders Back pain	3.9% 2/51 • Number of events 2 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	6.2% 3/48 • Number of events 4 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Musculoskeletal and connective tissue disorders Bone pain	5.9% 3/51 • Number of events 5 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	2.1% 1/48 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	11.1% 1/9 • Number of events 2 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Musculoskeletal and connective tissue disorders Muscle spasms	3.9% 2/51 • Number of events 2 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	4.2% 2/48 • Number of events 3 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/51 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	6.2% 3/48 • Number of events 3 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Musculoskeletal and connective tissue disorders Pain in extremity	3.9% 2/51 • Number of events 2 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	8.3% 4/48 • Number of events 8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	11.1% 1/9 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Musculoskeletal and connective tissue disorders Tendonitis	3.9% 2/51 • Number of events 2 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/48 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Nervous system disorders Complex regional pain syndrome	5.9% 3/51 • Number of events 4 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	2.1% 1/48 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	11.1% 1/9 • Number of events 2 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Nervous system disorders Dizziness	5.9% 3/51 • Number of events 3 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	2.1% 1/48 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Nervous system disorders Headache	9.8% 5/51 • Number of events 8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	6.2% 3/48 • Number of events 3 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Nervous system disorders Paraesthesia	2.0% 1/51 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	4.2% 2/48 • Number of events 3 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Nervous system disorders Taste disorder	3.9% 2/51 • Number of events 2 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/48 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Psychiatric disorders Anxiety	0.00% 0/51 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	4.2% 2/48 • Number of events 2 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Psychiatric disorders Insomnia	3.9% 2/51 • Number of events 2 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	2.1% 1/48 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Vascular disorders Hypertension	2.0% 1/51 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	4.2% 2/48 • Number of events 2 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/51 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/48 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	12.5% 1/8 • Number of events 3 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	11.1% 1/9 • Number of events 2 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Immune system disorders Hypersensitivity	0.00% 0/51 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/48 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	12.5% 1/8 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Blood and lymphatic system disorders Anaemia	0.00% 0/51 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/48 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	12.5% 1/8 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Eye disorders Eye pain	0.00% 0/51 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/48 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	11.1% 1/9 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Infections and infestations Abscess neck	0.00% 0/51 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/48 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	11.1% 1/9 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Infections and infestations Cellulitis	0.00% 0/51 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/48 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	11.1% 1/9 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Infections and infestations Clostridium difficile infection	0.00% 0/51 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/48 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	12.5% 1/8 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Infections and infestations Lyme disease	0.00% 0/51 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/48 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	12.5% 1/8 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Infections and infestations Infection protozoal	0.00% 0/51 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/48 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	12.5% 1/8 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Infections and infestations Pneumonia	0.00% 0/51 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/48 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	11.1% 1/9 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Injury, poisoning and procedural complications Fall	0.00% 0/51 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	2.1% 1/48 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	12.5% 1/8 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Injury, poisoning and procedural complications Radius fracture	0.00% 0/51 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/48 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	12.5% 1/8 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Investigations Blood immunoglobulin G decreased	0.00% 0/51 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/48 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	12.5% 1/8 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Renal and urinary disorders Renal pain	0.00% 0/51 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/48 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	11.1% 1/9 • Number of events 3 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Respiratory, thoracic and mediastinal disorders Cough	2.0% 1/51 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/48 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/43 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	11.1% 1/9 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).
Infections and infestations Diverticulitis	2.0% 1/51 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/48 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	2.3% 1/43 • Number of events 1 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/8 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/39 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).	0.00% 0/9 • Adverse events were documented from the time of enrollment (i.e., the time the informed consent form was signed) up to the time of the last protocol scheduled contact, i.e., date of last visit/contact (could be a phone call, e.g., in case of withdrawal). Only treatment emergent adverse events (TEAEs, i.e., those reported from baseline (after first administration of study medication) are reported in the tables below. Participants with TEAEs may be presented in 2 of 6 reporting groups depending on the time the TEAEs were reported. * Treatment Period A/Follow-up Period 1 (TPA): Baseline to Week 26 (Placebo or neridronic acid). * Treatment Period B/Follow-up Period 2 (TPB): Week 26 to Week 52 (follow-up without study medication administration) or Week 26 to Week 52 (participants with neridronic acid treatment after placebo and those receiving re-treatment with neridronic acid).

Additional Information

Director Clinical Trials

Grünenthal GmbH

Phone: +49 241 569

Email: Clinical-Trials@grunenthal.com

Results disclosure agreements

• Principal investigator is a sponsor employee The sponsor reserves the right to review any proposed full publication or poster or presentation of the results of this study by the coordinating or other investigator before they are submitted for publication or public disclosure. Neither the sponsor nor the coordinating investigator has the right to prohibit publication or public disclosure. Publication or public disclosure can be postponed for patent purposes.
• Publication restrictions are in place

Restriction type: OTHER