This study will be conducted to assess the efficacy, pharmacodynamic (PD), safety, tolerability, and immunogenicity of RGB -14- P compared to US-licensed Prolia® in participants with postmenopausal osteoporosis, in a comparative manner.
This is a randomized, double-blind, multicentre, multiple fixed-dose, 2-arm parallel-group study that includes 2 periods as: 1. Main period (52 weeks), consists of Treatment Period 1 (26 weeks) and Treatment Period 2 (26 weeks). On Day 1 of Treatment Period 1, prior to dosing, participants will be randomized in a 1:1 ratio to receive either RGB-14-P or Prolia®. 2. Transition Period: consists of Treatment Period 3 (26 weeks). On Day 1 of Treatment Period 3 (Week 52), a subset of participants who received Prolia® during the Main Period will be re-randomized 1:1 to receive either a dose RGB-14-P or Prolia® in a double-blinded manner. A subset of participants continuing in the Transition Period who received RGB-14-P during the Main Period will continue to receive a dose of RGB-14- P but will also follow the randomization procedure to maintain blinding. All participants will receive the study drugs on 2 occasions (Weeks 0 and 26), on Day 1 of Treatment Periods 1 and 2. Participants continuing to the Transition Period will receive the study drugs on a third-occasion (Week 52), Day 1 of Treatment Period 3. One Treatment Period will take 6 months (26 weeks, 183 days).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
473
Percentage Change From Baseline (%CfB) in Lumbar Spine Bone Mineral Density (BMD)
Percentage change from baseline in lumbar bone BMD was assessed. BMD at the lumbar spine was measured by dual-energy x-ray absorptiometry (DXA). This outcome measure was assessed for main period.
Time frame: Week 52
Area Under the Effective Curve (AUEC) After the First Dose Until Day 183 of %CfB in Serum Type I Collagen C-telopeptide (sCTX)
The AUEC of %CfB in sCTX of RGB-14-P was assessed as part of pharmacodynamics parameter with US-licensed Prolia® in female participants was demonstrated with postmenopausal osteoporosis. This outcome measure was assessed for main period only.
Time frame: Week 26
%CfB in Total Hip BMD
%CfB in total hip BMD was assessed.
Time frame: Weeks 26, 52 and 78
%CfB in Lumbar Spine BMD
%CfB in lumbar spine BMD was assessed.
Time frame: Weeks 26 and 78
%CfB in Femoral Neck BMD
%CfB in femoral neck BMD was assessed by DXA.
Time frame: Weeks 26, 52 and 78
Number of Participants With Vertebral Fragility Fracture
Number of participants with vertebral fragility fracture was assessed. Information on vertebral fractures was centrally collected through the evaluation of lateral thoraco-lumbar spine X-ray.
Time frame: Weeks 52 and 78
Number of Participants With Non-vertebral Fragility Fracture
Number of participants with non-vertebral fragility fracture was assessed. Information on non-vertebral fractures was centrally collected through the evaluation of lateral thoraco-lumbar spine X-ray.
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Miami, Florida, United States
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Miami Lakes, Florida, United States
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Decatur, Georgia, United States
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Las Vegas, Nevada, United States
Medical Center Hera EOOD - Rheumatology Office
Sofia, Sofia-Grad, Bulgaria
Medical Center Medconsult Pleven
Pleven, Bulgaria
UMHAT Kaspela
Plovdiv, Bulgaria
DKC "Sveti Georgi"
Plovdiv, Bulgaria
UMHAT Kaspela (Endocrinology/metabolic disease)
Plovdiv, Bulgaria
UMHAT Pulmed - Reumathology
Plovdiv, Bulgaria
...and 49 more locations
Time frame: Weeks 52 and 78
%CfB in Serum Procollagen Type 1 N Terminal Propeptide (P1NP)
%CfB in serum P1NP was assessed as part of pharmacodynamics parameter with US-licensed Prolia® in female participants with postmenopausal osteoporosis.
Time frame: Weeks 4, 26, 52 and 78
%CfB in Serum Type I Collagen C-telopeptide (sCTX)
%CfB in sCTX was assessed as part of pharmacodynamics parameter with US-licensed Prolia® was assessed in female participants with postmenopausal osteoporosis.
Time frame: Weeks 4, 26, 52 and 78
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
The safety and tolerability of RGB-14-P with US-licensed Prolia® in female participants with postmenopausal osteoporosis was assessed.
Time frame: Main Period: From screening (Weeks -5 to 0) to Week 52; Transition Period: From Week 52 to Week 78
Number of Participants With Anti-drug Antibodies (ADAs)
Number of participants with positive ADAs was assessed.
Time frame: Weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78
Number of Participants With Neutralizing Antibodies
Number of participants with positive neutralizing antibodies was assessed.
Time frame: Weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78
Titre of ADAs
The immunogenicity of RGB -14- P with US-licensed Prolia® in female participants with postmenopausal osteoporosis was assessed.
Time frame: Weeks 0, 2, 4, 26, 28, 30, 52, 54, 56 and 78