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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
479
PPD Global Ltd, Granta Park, Great Abington,
Cambridge, UK, United Kingdom
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
Time frame: Baseline and Week 52
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline up to Week 78
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Incidence of ADA (Anti-drug Antibody)
To compare immunogenicity between Bmab 1000 and Prolia®
Time frame: Week 78 (Transition Period)
Incidence of ADA (Anti-drug Antibody)
To compare immunogenicity between Bmab 1000 and Prolia®
Time frame: 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®
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)
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
Time frame: Week 52
Incidence of NAb (Neutralizing Antibody) up to Week 52
To compare immunogenicity between Bmab 1000 and Prolia®
Time frame: 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
Time frame: 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
Time frame: Week 78
Minimum Concentration (Cmin) of sCTX
To compare minimum Concentration (Cmin) of sCTX between Bmab 1000 and Prolia®
Time frame: baseline to Week 26
Denosumab Concentrations at Weeks 26
Serum Concentrations of Denosumab
Time frame: Weeks 26
Denosumab Concentrations at Weeks 52
Serum Concentrations of Denosumab
Time frame: Weeks 52
Denosumab Concentrations at Weeks 78
Serum Concentrations of Denosumab
Time frame: 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
Time frame: Week 52