Trial Outcomes & Findings for Comparison of Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia® in Postmenopausal Women With Osteoporosis (NCT NCT05345691)

Results Overview

To demonstrate equivalent efficacy between Bmab 1000 and Prolia® based on percentage change from baseline at Week 52 in lumbar spine BMD

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

479 participants

Primary outcome timeframe

Baseline and Week 52

Results posted on

2025-09-09

Participant Flow

The study was conducted at 42 sites across 4 countries, and enrolled 479 subjects

Participant milestones

Participant milestones
Measure	Part 1: Bmab 1000; Part 2: Bmab 1000-Bmab 1000 Part 1: Patients were randomly assigned at the baseline/randomization visit (Week 0/Day 1) to receive either Bmab 1000 or Prolia using a 1:1 allocation ratio. Part 2: All patients who completed Part 1 underwent the re-randomization process prior to the study drug administration at Week 52. Patients in the Prolia arm were randomly assigned in a 1:1 ratio to receive either Bmab 1000 or Prolia, to obtain data after a single switch in patients who had been treated with Prolia. To maintain the study blinding, the patients in the original Bmab 1000 arm also underwent the re-randomization procedure; however, they continued to receive Bmab 1000 treatment in Part 2	Part 1: Prolia®; Part 2: Prolia®-Bmab 1000 Part 1: Patients were randomly assigned at the baseline/randomization visit (Week 0/Day 1) to receive either Bmab 1000 or Prolia using a 1:1 allocation ratio. Part 2: All patients who completed Part 1 underwent the re-randomization process prior to the study drug administration at Week 52. Patients in the Prolia arm were randomly assigned in a 1:1 ratio to receive either Bmab 1000 or Prolia, to obtain data after a single switch in patients who had been treated with Prolia. To maintain the study blinding, the patients in the original Bmab 1000 arm also underwent the re-randomization procedure; however, they continued to receive Bmab 1000 treatment in Part 2	Part 1: Not Applicable; Part 2: Prolia®-Prolia® Part 1: Patients were randomly assigned at the baseline/randomization visit (Week 0/Day 1) to receive either Bmab 1000 or Prolia using a 1:1 allocation ratio. Part 2: All patients who completed Part 1 underwent the re-randomization process prior to the study drug administration at Week 52. Patients in the Prolia arm were randomly assigned in a 1:1 ratio to receive either Bmab 1000 or Prolia, to obtain data after a single switch in patients who had been treated with Prolia. To maintain the study blinding, the patients in the original Bmab 1000 arm also underwent the re-randomization procedure; however, they continued to receive Bmab 1000 treatment in Part 2
Part 1 STARTED	238	240	0
Part 1 COMPLETED	218	208	0
Part 1 NOT COMPLETED	20	32	0
Part 2 STARTED	218	104	104
Part 2 COMPLETED	216	103	103
Part 2 NOT COMPLETED	2	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia® in Postmenopausal Women With Osteoporosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bmab 1000 n=238 Participants Bmab 1000: 60 mg administered as a single subcutaneous (SC) injection once every 6 months.	Prolia®: n=241 Participants Prolia®: 60 mg administered as a single SC injection once every 6 months	Total n=479 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	84 Participants n=5 Participants	88 Participants n=7 Participants	172 Participants n=5 Participants
Age, Categorical >=65 years	154 Participants n=5 Participants	153 Participants n=7 Participants	307 Participants n=5 Participants
Age, Continuous	66.7 years STANDARD_DEVIATION 5.55 • n=5 Participants	66.5 years STANDARD_DEVIATION 5.77 • n=7 Participants	66.6 years STANDARD_DEVIATION 5.66 • n=5 Participants
Sex: Female, Male Female	238 Participants n=5 Participants	241 Participants n=7 Participants	479 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	237 participants n=5 Participants	241 participants n=7 Participants	478 participants n=5 Participants
Race/Ethnicity, Customized Japanese	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment United Kingdom	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment Europe	235 participants n=5 Participants	238 participants n=7 Participants	473 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 52

Population: Full analysis set

To demonstrate equivalent efficacy between Bmab 1000 and Prolia® based on percentage change from baseline at Week 52 in lumbar spine BMD

Outcome measures

Outcome measures
Measure	Bmab 1000 and Prolia n=237 Participants Bmab 1000: 60 mg administered as a single SC (subcutaneous) injection once every 6 months.	Prolia® n=235 Participants Prolia®: 60 mg administered as a single SC injection once every 6 months	Prolia®:-Prolia (Prolia in Double-blind Active-controlled Period)
Percentage Change in Lumbar Spine BMD (Bone Mineral Density)	1.698 Percent change Standard Error 0.5115	1.440 Percent change Standard Error 0.5089	—

SECONDARY outcome

Timeframe: Baseline to Week 26

Population: Modified Full Analysis Set

To demonstrate pharmacodynamic equivalence between Bmab 1000 and Prolia® based on AUEC of the bone resorption marker sCTX from baseline to week 26

Outcome measures

Outcome measures
Measure	Bmab 1000 and Prolia n=179 Participants Bmab 1000: 60 mg administered as a single SC (subcutaneous) injection once every 6 months.	Prolia® n=173 Participants Prolia®: 60 mg administered as a single SC injection once every 6 months	Prolia®:-Prolia (Prolia in Double-blind Active-controlled Period)
AUEC (Area Under the Effect Curve) of the Bone Resorption Marker sCTX (Serum C-terminal Telopeptide of Type 1 Collagen)	127 day*pg/mL Standard Deviation 85.2	123 day*pg/mL Standard Deviation 77.3	—

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: Full Analysis Set

To demonstrate equivalent efficacy between Bmab 1000 and Prolia® based on percentage change from baseline at Week 26 in lumbar spine BMD

Outcome measures

Outcome measures
Measure	Bmab 1000 and Prolia n=237 Participants Bmab 1000: 60 mg administered as a single SC (subcutaneous) injection once every 6 months.	Prolia® n=235 Participants Prolia®: 60 mg administered as a single SC injection once every 6 months	Prolia®:-Prolia (Prolia in Double-blind Active-controlled Period)
Percentage Change in Lumbar Spine BMD	3.872 Percent change Standard Error 0.7885	3.699 Percent change Standard Error 0.7860	—

SECONDARY outcome

Timeframe: Baseline upto week 26

Population: Full Analysis Set

To demonstrate equivalent efficacy between Bmab 1000 and Prolia® based on percentage change from baseline, at Week 26 and Week 52 in lumbar spine BMD

Outcome measures

Outcome measures
Measure	Bmab 1000 and Prolia n=237 Participants Bmab 1000: 60 mg administered as a single SC (subcutaneous) injection once every 6 months.	Prolia® n=235 Participants Prolia®: 60 mg administered as a single SC injection once every 6 months	Prolia®:-Prolia (Prolia in Double-blind Active-controlled Period)
Percentage Change in Total Hip BMD by DXA (Dual-energy X-ray Absorptiometry)	1.698 Percent change Standard Error 0.5115	1.440 Percent change Standard Error 0.5089	—

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: Modified Full Analysis Set

To compare bone turnover between Bmab 1000 and Prolia® based on P1NP after the first dose

Outcome measures

Outcome measures
Measure	Bmab 1000 and Prolia n=178 Participants Bmab 1000: 60 mg administered as a single SC (subcutaneous) injection once every 6 months.	Prolia® n=177 Participants Prolia®: 60 mg administered as a single SC injection once every 6 months	Prolia®:-Prolia (Prolia in Double-blind Active-controlled Period)
Serum Concentrations of P1NP (Procollagen Type 1 N-terminal Propeptide)	69.4 ng/ml Standard Deviation 161	42.9 ng/ml Standard Deviation 94	—

SECONDARY outcome

Timeframe: Baseline up to Week 78

To compare safety and tolerability of 2 administrations of Bmab 1000 and Prolia® 6 months apart

Outcome measures

Outcome measures
Measure	Bmab 1000 and Prolia n=218 Participants Bmab 1000: 60 mg administered as a single SC (subcutaneous) injection once every 6 months.	Prolia® n=104 Participants Prolia®: 60 mg administered as a single SC injection once every 6 months	Prolia®:-Prolia n=104 Participants (Prolia in Double-blind Active-controlled Period)
Incidence of TEAEs (Treatment-emergent Adverse Events) up to 6 Months After the Second Dose	55 Participants	29 Participants	27 Participants

SECONDARY outcome

Timeframe: Week 78 (Transition Period)

Population: Safety Analysis Set for Transition Period

To compare immunogenicity between Bmab 1000 and Prolia®

Outcome measures

Outcome measures
Measure	Bmab 1000 and Prolia n=218 Participants Bmab 1000: 60 mg administered as a single SC (subcutaneous) injection once every 6 months.	Prolia® n=104 Participants Prolia®: 60 mg administered as a single SC injection once every 6 months	Prolia®:-Prolia n=104 Participants (Prolia in Double-blind Active-controlled Period)
Incidence of ADA (Anti-drug Antibody)	46 Participants	13 Participants	14 Participants

SECONDARY outcome

Timeframe: Baseline up to Week 52 (Double-blind Active-controlled Period)

Population: Safety Analysis Set

To compare immunogenicity between Bmab 1000 and Prolia®

Outcome measures

Outcome measures
Measure	Bmab 1000 and Prolia n=238 Participants Bmab 1000: 60 mg administered as a single SC (subcutaneous) injection once every 6 months.	Prolia® n=240 Participants Prolia®: 60 mg administered as a single SC injection once every 6 months	Prolia®:-Prolia (Prolia in Double-blind Active-controlled Period)
Incidence of ADA (Anti-drug Antibody)	215 Participants	205 Participants	—

SECONDARY outcome

Timeframe: Baseline up to Week 52 (Double-blind Active-controlled Period)

To compare immunogenicity between Bmab 1000 and Prolia®

Outcome measures

Outcome measures
Measure	Bmab 1000 and Prolia n=238 Participants Bmab 1000: 60 mg administered as a single SC (subcutaneous) injection once every 6 months.	Prolia® n=240 Participants Prolia®: 60 mg administered as a single SC injection once every 6 months	Prolia®:-Prolia (Prolia in Double-blind Active-controlled Period)
Incidence of NAb (Neutralizing Antibody) up to Week 52	7 Participants	5 Participants	—

SECONDARY outcome

Timeframe: Week 52

To demonstrate equivalent efficacy between Bmab 1000 and Prolia® based on percentage change from baseline, at Week 26 and Week 52 in lumbar spine BMD

Outcome measures

Outcome measures
Measure	Bmab 1000 and Prolia n=237 Participants Bmab 1000: 60 mg administered as a single SC (subcutaneous) injection once every 6 months.	Prolia® n=235 Participants Prolia®: 60 mg administered as a single SC injection once every 6 months	Prolia®:-Prolia (Prolia in Double-blind Active-controlled Period)
Percentage Change in Total Hip BMD by DXA (Dual-energy X-ray Absorptiometry)	2.224 Percent change Standard Error 0.5532	2.132 Percent change Standard Error 0.5513	—

SECONDARY outcome

Timeframe: Week 78 (Transition Period)

Population: Safety Analysis Set for Transition Period

To compare immunogenicity between Bmab 1000 and Prolia®

Outcome measures

Outcome measures
Measure	Bmab 1000 and Prolia n=218 Participants Bmab 1000: 60 mg administered as a single SC (subcutaneous) injection once every 6 months.	Prolia® n=104 Participants Prolia®: 60 mg administered as a single SC injection once every 6 months	Prolia®:-Prolia n=104 Participants (Prolia in Double-blind Active-controlled Period)
Incidence of NAb (Neutralizing Antibody) up to Week 52	3 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 78

Population: Full Analysis Set for Transition Period

To demonstrate equivalent efficacy between Bmab 1000 and Prolia® based on percentage change from baseline at Week 78 in Hip BMD

Outcome measures

Outcome measures
Measure	Bmab 1000 and Prolia n=216 Participants Bmab 1000: 60 mg administered as a single SC (subcutaneous) injection once every 6 months.	Prolia® n=103 Participants Prolia®: 60 mg administered as a single SC injection once every 6 months	Prolia®:-Prolia n=103 Participants (Prolia in Double-blind Active-controlled Period)
Percentage Change From Baseline in Hip BMD	4.011 Percent change Standard Deviation 2.7744	4.052 Percent change Standard Deviation 3.4300	3.483 Percent change Standard Deviation 2.6155

SECONDARY outcome

Timeframe: Week 78

Population: Full Analysis Set for Transition Period

To demonstrate equivalent efficacy between Bmab 1000 and Prolia® based on percentage change from baseline at Week 78 in Femoral BMD

Outcome measures

Outcome measures
Measure	Bmab 1000 and Prolia n=216 Participants Bmab 1000: 60 mg administered as a single SC (subcutaneous) injection once every 6 months.	Prolia® n=103 Participants Prolia®: 60 mg administered as a single SC injection once every 6 months	Prolia®:-Prolia n=103 Participants (Prolia in Double-blind Active-controlled Period)
Percentage Change From Baseline in Femoral BMD	3.666 Percent change Standard Deviation 3.6640	3.333 Percent change Standard Deviation 3.5021	2.834 Percent change Standard Deviation 3.9551

SECONDARY outcome

Timeframe: baseline to Week 26

Population: Modified Full Analysis Set

To compare minimum Concentration (Cmin) of sCTX between Bmab 1000 and Prolia®

Outcome measures

Outcome measures
Measure	Bmab 1000 and Prolia n=236 Participants Bmab 1000: 60 mg administered as a single SC (subcutaneous) injection once every 6 months.	Prolia® n=227 Participants Prolia®: 60 mg administered as a single SC injection once every 6 months	Prolia®:-Prolia (Prolia in Double-blind Active-controlled Period)
Minimum Concentration (Cmin) of sCTX	41.5 pg/mL Standard Deviation 18.2	41.1 pg/mL Standard Deviation 17.8	—

SECONDARY outcome

Timeframe: Weeks 26

Population: Modified Full Analysis Set

Serum Concentrations of Denosumab

Outcome measures

Outcome measures
Measure	Bmab 1000 and Prolia n=185 Participants Bmab 1000: 60 mg administered as a single SC (subcutaneous) injection once every 6 months.	Prolia® n=178 Participants Prolia®: 60 mg administered as a single SC injection once every 6 months	Prolia®:-Prolia (Prolia in Double-blind Active-controlled Period)
Denosumab Concentrations at Weeks 26	53.6 ng/mL Standard Deviation 119	40.7 ng/mL Standard Deviation 88.1	—

SECONDARY outcome

Timeframe: Weeks 52

Population: Modified Full Analysis Set

Serum Concentrations of Denosumab

Outcome measures

Outcome measures
Measure	Bmab 1000 and Prolia n=178 Participants Bmab 1000: 60 mg administered as a single SC (subcutaneous) injection once every 6 months.	Prolia® n=177 Participants Prolia®: 60 mg administered as a single SC injection once every 6 months	Prolia®:-Prolia (Prolia in Double-blind Active-controlled Period)
Denosumab Concentrations at Weeks 52	69.4 ng/mL Standard Deviation 161	42.9 ng/mL Standard Deviation 94.0	—

SECONDARY outcome

Timeframe: Weeks 78

Population: Modified Full Analysis Set

Serum Concentrations of Denosumab

Outcome measures

Outcome measures
Measure	Bmab 1000 and Prolia n=176 Participants Bmab 1000: 60 mg administered as a single SC (subcutaneous) injection once every 6 months.	Prolia® n=79 Participants Prolia®: 60 mg administered as a single SC injection once every 6 months	Prolia®:-Prolia n=83 Participants (Prolia in Double-blind Active-controlled Period)
Denosumab Concentrations at Weeks 78	87.6 ng/mL Standard Deviation 223	72.1 ng/mL Standard Deviation 174	66.2 ng/mL Standard Deviation 111

SECONDARY outcome

Timeframe: Week 52

Population: Full Analysis Set

To demonstrate equivalent efficacy between Bmab 1000 and Prolia® based on percentage change from baseline at Week 52 in Femoral BMD

Outcome measures

Outcome measures
Measure	Bmab 1000 and Prolia n=237 Participants Bmab 1000: 60 mg administered as a single SC (subcutaneous) injection once every 6 months.	Prolia® n=235 Participants Prolia®: 60 mg administered as a single SC injection once every 6 months	Prolia®:-Prolia (Prolia in Double-blind Active-controlled Period)
Percentage Change From Baseline in Femoral BMD	2.138 Percent change Standard Error 0.8042	1.767 Percent change Standard Error 0.7999	—

Adverse Events

Bmab 1000

Serious events: 15 serious events

Other events: 144 other events

Deaths: 0 deaths

Prolia®:

Serious events: 2 serious events

Other events: 72 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Sarika S Deodhar

Biocon Biologics Limited

Phone: 0802808

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee On Protocol signature page, investigator (PI) declares by signing that "I will not disclose information regarding this clinical investigation or publish results of the investigation without authorization from Biocon Biologics UK Limited."
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	Bmab 1000 n=218 participants at risk Bmab 1000: 60 mg administered as a single SC (subcutaneous) injection once every 6 months.	Prolia®: n=104 participants at risk Prolia®: 60 mg administered as a single SC injection once every 6 months
Gastrointestinal disorders Abdominal pain	0.46% 1/218 • Number of events 1 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	0.00% 0/104 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Gastrointestinal disorders Gastric ulcer	0.46% 1/218 • Number of events 1 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	0.00% 0/104 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Gastrointestinal disorders Inflammatory bowel disease	0.46% 1/218 • Number of events 1 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	0.00% 0/104 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Infections and infestations Urosepsis	0.46% 1/218 • Number of events 1 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	0.00% 0/104 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Infections and infestations Vestibular neuronitis	0.46% 1/218 • Number of events 1 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	0.00% 0/104 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	0.46% 1/218 • Number of events 1 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	0.00% 0/104 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.46% 1/218 • Number of events 1 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	0.00% 0/104 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.46% 1/218 • Number of events 1 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	0.00% 0/104 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive lobular breast carcinoma	0.00% 0/218 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	0.96% 1/104 • Number of events 1 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Nervous system disorders Dizziness	0.92% 2/218 • Number of events 2 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	0.00% 0/104 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Reproductive system and breast disorders Endometrial hyperplasia	0.46% 1/218 • Number of events 1 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	0.00% 0/104 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Reproductive system and breast disorders Ovarian cyst	0.46% 1/218 • Number of events 1 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	0.00% 0/104 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Cardiac disorders Atrial fibrillation	0.00% 0/218 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	0.96% 1/104 • Number of events 1 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Ear and labyrinth disorders Ear inflammation	0.46% 1/218 • Number of events 1 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	0.00% 0/104 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Ear and labyrinth disorders Noninfective mastoiditis	0.46% 1/218 • Number of events 1 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	0.00% 0/104 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Eye disorders Cataract	0.46% 1/218 • Number of events 1 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	0.00% 0/104 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
General disorders Non-cardiac chest pain	0.46% 1/218 • Number of events 1 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	0.00% 0/104 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Injury, poisoning and procedural complications Arterial injury	0.46% 1/218 • Number of events 1 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	0.00% 0/104 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Renal and urinary disorders Ureterolithiasis	0.46% 1/218 • Number of events 1 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	0.00% 0/104 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Respiratory, thoracic and mediastinal disorders Allergic sinusitis	0.46% 1/218 • Number of events 1 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	0.00% 0/104 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.

Other adverse events
Measure	Bmab 1000 n=218 participants at risk Bmab 1000: 60 mg administered as a single SC (subcutaneous) injection once every 6 months.	Prolia®: n=104 participants at risk Prolia®: 60 mg administered as a single SC injection once every 6 months
Infections and infestations Bronchitis	3.2% 7/218 • Number of events 8 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	1.9% 2/104 • Number of events 2 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Infections and infestations COVID-19	4.6% 10/218 • Number of events 10 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	6.7% 7/104 • Number of events 8 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Infections and infestations Cystitis	1.4% 3/218 • Number of events 4 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	3.8% 4/104 • Number of events 4 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Infections and infestations Laryngitis	2.3% 5/218 • Number of events 5 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	0.96% 1/104 • Number of events 1 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Infections and infestations Nasopharyngitis	6.0% 13/218 • Number of events 16 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	7.7% 8/104 • Number of events 8 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Infections and infestations Pharyngitis	3.2% 7/218 • Number of events 10 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	0.00% 0/104 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Infections and infestations Sinusitis	0.00% 0/218 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	5.8% 6/104 • Number of events 6 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Infections and infestations Upper respiratory tract infection	8.3% 18/218 • Number of events 21 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	11.5% 12/104 • Number of events 14 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Infections and infestations Urinary tract infection	6.4% 14/218 • Number of events 14 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	1.9% 2/104 • Number of events 2 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Musculoskeletal and connective tissue disorders Arthralgia	4.6% 10/218 • Number of events 12 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	4.8% 5/104 • Number of events 7 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Musculoskeletal and connective tissue disorders Back pain	5.5% 12/218 • Number of events 12 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	2.9% 3/104 • Number of events 3 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Musculoskeletal and connective tissue disorders Myalgia	0.92% 2/218 • Number of events 2 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	2.9% 3/104 • Number of events 3 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Musculoskeletal and connective tissue disorders Osteoarthritis	5.0% 11/218 • Number of events 13 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	0.96% 1/104 • Number of events 1 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Musculoskeletal and connective tissue disorders Pain in extremity	2.3% 5/218 • Number of events 7 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	0.00% 0/104 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Nervous system disorders Dizziness	2.8% 6/218 • Number of events 6 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	3.8% 4/104 • Number of events 5 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Nervous system disorders Headache	5.0% 11/218 • Number of events 12 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	4.8% 5/104 • Number of events 6 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Metabolism and nutrition disorders Hypercholesterolaemia	3.2% 7/218 • Number of events 7 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	7.7% 8/104 • Number of events 8 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Investigations Blood parathyroid hormone increased	0.92% 2/218 • Number of events 3 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	2.9% 3/104 • Number of events 3 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
Vascular disorders Hypertension	3.2% 7/218 • Number of events 7 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	3.8% 4/104 • Number of events 4 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.
General disorders Injection site erythema	1.4% 3/218 • Number of events 4 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.	2.9% 3/104 • Number of events 4 • 0- 78 weeks All Deaths, Serious Adverse Events, and Other Adverse Events were described. For Other adverse Events, a threshold of 2% was used. Only one Death was reported during part 1 of the study. Total no. of patients at risk for all-cause mortality is different as compared to the participant at risk for SAEs and other AEs reported throughout the study. Throughout the study is defined as all patients who received Bmab1000 throughout the study or Prolia throughout the study i.e. up to week 78.