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

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
Primary Purpose: Efficacy and safety evaluation of TST002 in postmenopausal osteoporosisand low bone mass.Design: 5‐arm, randomized, double‐blind (denosumab arm open‐label), placebo‐ andactive‐comparator (denosumab)‐controlled, parallel‐group study with stratified blockrandomization by screening BMD T‐score (Stratum 1: T‐score ≥ ‐2.00; Stratum 2: T‐score <‐2.00 at all sites). Enrollment capped at <20% Stratum 1 participants per arm.All participants receive daily calcium (600‐1200 mg elemental) and vitamin D (725‐1450IU) supplementation from screening through study end, with an optional vitamin D loadingdose for those with baseline 25(OH)D 20‐40 ng/mL.Unblinding: Primary analysis after all participants complete Week 24 is performed by anunblinded CRO team; investigators, participants, and the CRO study team (except for theopen‐label denosumab arm) remain blinded until final study unblinding
Epistemonikos ID: 61966c5d9108b5ede2f8cfd13774aacc0ba4b571
First added on: Sep 09, 2026