Postmenopausal Women With OsteoporosisPhase 3DEVOTENCT05345691
Comparison of Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia® in Postmenopausal Women With Osteoporosis
A Phase 3 study testing Bmab 1000 and Prolia® in people with Postmenopausal Women With Osteoporosis, run by Biocon Biologics UK Ltd at 1 site in United Kingdom.
Trial summary
This is a randomized, double-blind, multicenter, parallel-arm, Phase 3 study to compare the efficacy, PK (Pharmacokinetic), PD (Pharmacodynamic), safety, and immunogenicity of Bmab 1000 and Prolia® in postmenopausal women with osteoporosis Read more about this study
- Who is it for?
- Ages 55 to 80 years, women only
- Conditions the study is for
- Postmenopausal Women With Osteoporosis
- What is being tested?
- Bmab 1000 and Prolia®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 479 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 May 2022to 12 Jun 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women, aged ≥55 and <80 years at screening. Postmenopausal is defined as 12 months of spontaneous amenorrhea with serum FSH (follicle-stimulating hormone) levels ≥40 mIU/mL at screening or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
- Evidence of osteoporosis as assessed by lumbar spine (L1-L4) absolute BMD corresponding to a T-score classification ≤-2.5 and ≥-4.0.
- At least 3 vertebrae in the L1-L4 region and at least one hip joint are evaluable by DXA at screening.
- Patients with body weight ≥50 to <90 kg at screening.
Who cannot join
- Patients with T-score of <-4.0 at the lumbar spine, total hip, or femoral neck.
- Known history of previous exposure to denosumab (Prolia®, Xgeva®, or any biosimilar denosumab).
- For prior or ongoing use of any osteoporosis treatment (other than calcium and vitamin D supplements) following points to be considered for the washout periods prior to the screening visit:
- Oral bisphosphonate i. Ineligible if used for 3 or more years cumulatively ii. If used for <3 years, a gap of at least 1 year since the last dose is required at the screening visit b. Dose received any time
- Systemic glucocorticosteroids
- Patients with ongoing serious infections
Show all 17Show fewer
- Evidence of any of the following per the patient's history, DXA, or X-ray review and/or current disease:
- Patient in bed rest for 2 or more weeks during the last 3 months prior to screening
- Current hyperthyroidism or hypothyroidism
- History and/or current hyperparathyroidism or hypoparathyroidism
- Current hypocalcemia or hypercalcemia based on albumin-adjusted serum calcium
- Any bone disease including bone metastasis or metabolic disease (except for osteoporosis), eg, osteomalacia or osteogenesis imperfecta, rheumatoid arthritis, Paget's disease, ALP (alkaline phosphatase) elevation (at investigator's discretion), Cushing's disease, clinically significant hyperprolactinemia (at investigator's discretion), fibrous dysplasia, malabsorption syndrome which may interfere with the interpretation of the results
- History and/or presence of one severe or 3 or more moderate vertebral fractures
- History and/or presence of hip fracture or bilateral hip replacement
- Presence of an active healing fracture according to assessment of investigator
- History of severe skeletal pain with bisphosphonates which, as per the investigator, is a risk to her participation in the trial
- Oral/dental or periodontal conditions:
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
PPD Global Ltd, Granta Park, Great Abington,
Cambridge, UK, CB21 6GQ
About this study
Official title: A Randomized, Double-Blind, Multicenter, Parallel-Arm Phase 3 Study to Compare the Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia® in Postmenopausal Women With Osteoporosis
This is a randomized, double-blind, multicenter, parallel-arm, Phase 3 study to compare the efficacy, PK (Pharmacokinetic), PD (Pharmacodynamic), safety, and immunogenicity of Bmab 1000 and Prolia® in postmenopausal women with osteoporosis
Read the detailed description
The study will consist of 3 study periods: Screening period; Part 1, double-blind active-controlled period; and Part 2, transition period. In the double-blind active-controlled period, eligible Patients will be randomized in a 1:1 ratio to receive either Bmab 1000 or Prolia®. Prior to dosing At Week 52, patients in Prolia® treatment group will be randomized again in a 1:1 ratio to either continue on Prolia® or be transitioned to Bmab 1000. To maintain the study blinding, the patients in the original Bmab 1000 arm will also go through the re-randomization procedure; however, they will continue to receive Bmab 1000. The interventions (Bmab 1000 or Prolia®) will be administered subcutaneously every 6 months. End-of-study visit will be at Week 78 post randomization (Month 18).
- Conditions
- Postmenopausal Women With Osteoporosis
- Being tested
- Bmab 1000, Prolia®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bmab 1000Biological
60 mg administered as a single SC (subcutaneous) injection once every 6 months.
Prolia®Biological
60 mg administered as a single SC injection once every 6 months
| Study group | Role | What they receive |
|---|---|---|
| Bmab 1000 | Experimental | Not described Receives: Biological: Bmab 1000 |
| Prolia®: | Active comparator | Not described Receives: Biological: Prolia® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Lumbar Spine BMD (Bone Mineral Density)
To demonstrate equivalent efficacy between Bmab 1000 and Prolia® based on percentage change from baseline at Week 52 in lumbar spine BMD
Measured: Baseline and Week 52
Secondary outcomes (17)
AUEC (Area Under the Effect Curve) of the Bone Resorption Marker sCTX (Serum C-terminal Telopeptide of Type 1 Collagen)
To demonstrate pharmacodynamic equivalence between Bmab 1000 and Prolia® based on AUEC of the bone resorption marker sCTX from baseline to week 26
Measured: Baseline to Week 26
Percentage Change in Lumbar Spine BMD
To demonstrate equivalent efficacy between Bmab 1000 and Prolia® based on percentage change from baseline at Week 26 in lumbar spine BMD
Measured: Baseline and Week 26
Percentage Change in Total Hip BMD by DXA (Dual-energy X-ray Absorptiometry)
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
Measured: Baseline upto week 26
Serum Concentrations of P1NP (Procollagen Type 1 N-terminal Propeptide)
To compare bone turnover between Bmab 1000 and Prolia® based on P1NP after the first dose
Measured: Baseline up to Week 52
Incidence of TEAEs (Treatment-emergent Adverse Events) up to 6 Months After the Second Dose
To compare safety and tolerability of 2 administrations of Bmab 1000 and Prolia® 6 months apart
Measured: Baseline up to Week 78
Incidence of ADA (Anti-drug Antibody)
To compare immunogenicity between Bmab 1000 and Prolia®
Measured: Week 78 (Transition Period)
Incidence of ADA (Anti-drug Antibody)
To compare immunogenicity between Bmab 1000 and Prolia®
Measured: Baseline up to Week 52 (Double-blind Active-controlled Period)
Incidence of NAb (Neutralizing Antibody) up to Week 52
To compare immunogenicity between Bmab 1000 and Prolia®
Measured: Baseline up to Week 52 (Double-blind Active-controlled Period)
Percentage Change in Total Hip BMD by DXA (Dual-energy X-ray Absorptiometry)
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
Measured: Week 52
Incidence of NAb (Neutralizing Antibody) up to Week 52
To compare immunogenicity between Bmab 1000 and Prolia®
Measured: Week 78 (Transition Period)
Percentage Change From Baseline in Hip BMD
To demonstrate equivalent efficacy between Bmab 1000 and Prolia® based on percentage change from baseline at Week 78 in Hip BMD
Measured: Week 78
Percentage Change From Baseline in Femoral BMD
To demonstrate equivalent efficacy between Bmab 1000 and Prolia® based on percentage change from baseline at Week 78 in Femoral BMD
Measured: Week 78
Minimum Concentration (Cmin) of sCTX
To compare minimum Concentration (Cmin) of sCTX between Bmab 1000 and Prolia®
Measured: baseline to Week 26
Denosumab Concentrations at Weeks 26
Serum Concentrations of Denosumab
Measured: Weeks 26
Denosumab Concentrations at Weeks 52
Serum Concentrations of Denosumab
Measured: Weeks 52
Denosumab Concentrations at Weeks 78
Serum Concentrations of Denosumab
Measured: Weeks 78
Percentage Change From Baseline in Femoral BMD
To demonstrate equivalent efficacy between Bmab 1000 and Prolia® based on percentage change from baseline at Week 52 in Femoral BMD
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start24 May 2022
- Primary completion12 Jun 2024
- Study completion12 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal Women With OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 479 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocon Biologics UK Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345691
- Sponsor's protocol ID
- B1000-PMO-03-G-02
- Acronym
- DEVOTE
- Status last verified
- Aug 2025
- First submitted
- 12 Apr 2022
- Last updated
- 9 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Krishnan A, Bp S, Mehta G, Ramaswamy S, Chakraborty S, Mandal S. From anti-drug antibody incidence to clinical relevance: interpreting highly sensitive immunogenicity assays in biosimilars. Bioanalysis. 2026 Aug 26:1-14. doi: 10.1080/17576180.2026.2715917. Online ahead of print.
PubMed 42643157Eastell R, Orwoll E, Cosman F, Plebanski R, Kumar K, Marwah A, Deodhar SS, Wolff-Holz E, Loganathan S. Efficacy, pharmacodynamics, pharmacokinetics, safety, and immunogenicity of Bmab 1000 vs reference denosumab: 78-wk results from a randomized, double-blind, multicenter, parallel-arm Phase 3 trial (DEVOTE) in women with postmenopausal osteoporosis. JBMR Plus. 2026 Apr 11;10(6):ziag062. doi: 10.1093/jbmrpl/ziag062. eCollection 2026 Jun.
PubMed 42110973
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Multicenter, Parallel-Arm Phase 3 Study to Compare the Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia® in Postmenopausal Women With Osteoporosis
- ClinicalTrials.gov ID
- NCT05345691
- Acronym / sponsor ID
- DEVOTE / B1000-PMO-03-G-02
- Conditions
- Postmenopausal Women With Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 479 participants (actual)
- Lead sponsor
- Biocon Biologics UK LtdIndustry (pharma, biotech, devices)
- Study start
- 24 May 2022 (actual)
- Primary completion
- 12 Jun 2024 (actual)
- Study completion
- 12 Jun 2024 (actual)
- First posted
- 26 Apr 2022 (actual)
- Results
- Posted 19 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, multicenter, parallel-arm, Phase 3 study to compare the efficacy, PK (Pharmacokinetic), PD (Pharmacodynamic), safety, and immunogenicity of Bmab 1000 and Prolia® in postmenopausal women with osteoporosis
Detailed description
The study will consist of 3 study periods: Screening period; Part 1, double-blind active-controlled period; and Part 2, transition period. In the double-blind active-controlled period, eligible Patients will be randomized in a 1:1 ratio to receive either Bmab 1000 or Prolia®. Prior to dosing At Week 52, patients in Prolia® treatment group will be randomized again in a 1:1 ratio to either continue on Prolia® or be transitioned to Bmab 1000. To maintain the study blinding, the patients in the original Bmab 1000 arm will also go through the re-randomization procedure; however, they will continue to receive Bmab 1000. The interventions (Bmab 1000 or Prolia®) will be administered subcutaneously every 6 months. End-of-study visit will be at Week 78 post randomization (Month 18).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bmab 1000 | Experimental | Biological: Bmab 1000 |
| Prolia®: | Active comparator | Biological: Prolia® |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Postmenopausal women, aged ≥55 and <80 years at screening. Postmenopausal is defined as 12 months of spontaneous amenorrhea with serum FSH (follicle-stimulating hormone) levels ≥40 mIU/mL at screening or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
- Evidence of osteoporosis as assessed by lumbar spine (L1-L4) absolute BMD corresponding to a T-score classification ≤-2.5 and ≥-4.0.
- At least 3 vertebrae in the L1-L4 region and at least one hip joint are evaluable by DXA at screening.
- Patients with body weight ≥50 to <90 kg at screening.
Key exclusion criteria (17 listed)
- Patients with T-score of <-4.0 at the lumbar spine, total hip, or femoral neck.
- Known history of previous exposure to denosumab (Prolia®, Xgeva®, or any biosimilar denosumab).
- For prior or ongoing use of any osteoporosis treatment (other than calcium and vitamin D supplements) following points to be considered for the washout periods prior to the screening visit:
- Systemic glucocorticosteroids
- Patients with ongoing serious infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bmab 100060 mg administered as a single SC (subcutaneous) injection once every 6 months. | Biological | Bmab 1000 |
| Prolia®60 mg administered as a single SC injection once every 6 months | Biological | Prolia®: |
Primary outcome
Percentage Change in Lumbar Spine BMD (Bone Mineral Density)
Time frame: Baseline and Week 52
To demonstrate equivalent efficacy between Bmab 1000 and Prolia® based on percentage change from baseline at Week 52 in lumbar spine BMD
17 secondary outcomes
AUEC (Area Under the Effect Curve) of the Bone Resorption Marker sCTX (Serum C-terminal Telopeptide of Type 1 Collagen)
Time frame: Baseline to Week 26
Percentage Change in Lumbar Spine BMD
Time frame: Baseline and Week 26
Percentage Change in Total Hip BMD by DXA (Dual-energy X-ray Absorptiometry)
Time frame: Baseline upto week 26
Serum Concentrations of P1NP (Procollagen Type 1 N-terminal Propeptide)
Time frame: Baseline up to Week 52
Incidence of TEAEs (Treatment-emergent Adverse Events) up to 6 Months After the Second Dose
Time frame: Baseline up to Week 78
Incidence of ADA (Anti-drug Antibody)
Time frame: Week 78 (Transition Period)
Incidence of ADA (Anti-drug Antibody)
Time frame: Baseline up to Week 52 (Double-blind Active-controlled Period)
Incidence of NAb (Neutralizing Antibody) up to Week 52
Time frame: Baseline up to Week 52 (Double-blind Active-controlled Period)
Percentage Change in Total Hip BMD by DXA (Dual-energy X-ray Absorptiometry)
Time frame: Week 52
Incidence of NAb (Neutralizing Antibody) up to Week 52
Time frame: Week 78 (Transition Period)
Percentage Change From Baseline in Hip BMD
Time frame: Week 78
Percentage Change From Baseline in Femoral BMD
Time frame: Week 78
Minimum Concentration (Cmin) of sCTX
Time frame: baseline to Week 26
Denosumab Concentrations at Weeks 26
Time frame: Weeks 26
Denosumab Concentrations at Weeks 52
Time frame: Weeks 52
Denosumab Concentrations at Weeks 78
Time frame: Weeks 78
Percentage Change From Baseline in Femoral BMD
Time frame: Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42643157Krishnan A, Bp S, Mehta G, Ramaswamy S, Chakraborty S, Mandal S. From anti-drug antibody incidence to clinical relevance: interpreting highly sensitive immunogenicity assays in biosimilars. Bioanalysis. 2026 Aug 26:1-14. doi: 10.1080/17576180.2026.2715917. Online ahead of print.
- Derived from this study: PubMed 42110973Eastell R, Orwoll E, Cosman F, Plebanski R, Kumar K, Marwah A, Deodhar SS, Wolff-Holz E, Loganathan S. Efficacy, pharmacodynamics, pharmacokinetics, safety, and immunogenicity of Bmab 1000 vs reference denosumab: 78-wk results from a randomized, double-blind, multicenter, parallel-arm Phase 3 trial (DEVOTE) in women with postmenopausal osteoporosis. JBMR Plus. 2026 Apr 11;10(6):ziag062. doi: 10.1093/jbmrpl/ziag062. eCollection 2026 Jun.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bmab 1000 and Prolia® in people with Postmenopausal Women With Osteoporosis, run by Biocon Biologics UK Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in Lumbar Spine BMD (Bone Mineral Density) (time frame: Baseline and Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05345691, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.