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Study of TST002 Injection in Postmenopausal Women With Osteoporosis or Low Bone Mass

StatusNot Yet Recruiting
PhasePhase 2
Started
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Record History

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  1. Sponsor changed: Suzhou Transcenta Therapeutics Co., Ltd. to Transcenta Therapeutics (Hangzhou) Co., Ltd.
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a randomized, double-blind, placebo- and active-controlled Phase II study evaluating the efficacy and safety of TST002 injection (a humanized monoclonal antibody) in postmenopausal women with osteoporosis or low bone mass, aged 45-80 years. Approximately 110 participants will be randomized 1:1:1:1:1 (stratified by baseline BMD T-score) to one of five arms: TST002 400 mg every 8 weeks (Q8W), TST002 800 mg Q8W, TST002 1200 mg every 12 weeks (Q12W), placebo, or open-label denosumab 60 mg subcutaneously every 24 weeks. The study includes a screening period (Day -28 to Day -1), a main study period (Week 0-24), and an extension period (Week 25-52), with all participants followed through Week 52 (Day 365). The primary objective is to evaluate the effect of repeated IV TST002 infusions on lumbar spine bone mineral density (BMD). Secondary objectives include characterization of pharmacokinetics, pharmacodynamics, immunogenicity, safety, and tolerability.
Trial Details
NCT Number NCT07806331
Lead Sponsor Transcenta Therapeutics (Hangzhou) Co., Ltd.
Conditions
(from sponsor)		 Postmenopausal Osteoporosis, Low Bone Mass
Related terms Osteoporosis, Postmenopausal, Sclerosteosis
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov