Health TrialsbyHealthPanel

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

ConditionsPostmenopausal OsteoporosisLow Bone Mass
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age45-80
SponsorTranscenta Therapeutics (Hangzhou) Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntary signed informed consent; able to walk freely; willing/able to complete all study procedures.

BMI 18.0-30.0 kg/m² (inclusive); body weight ≥45 kg.

Postmenopausal women aged 45-80 years (inclusive) at screening, postmenopausal ≥2 years (≥12 consecutive months without spontaneous vaginal bleeding/spotting).

BMD T-score <-2.00 at lumbar spine (L1-L4 total), total hip, or femoral neck at screening; OR history of fragility fracture with T-score <-1.00 at one of these sites (central imaging read).

Disqualifiers

BMD T-score ≤-3.50 at lumbar spine, total hip, or femoral neck at screening.

Prior hip fracture.

≥2 vertebral fractures on screening lateral spine X-ray (investigator-assessed).

Known skeletal, endocrine, or rheumatic disease that could confound results (e.g., Paget's disease, osteomalacia, osteopetrosis, osteogenesis imperfecta, sclerosteosis, rheumatoid arthritis, ankylosing spondylitis, Cushing's disease, hyperprolactinemia, uncontrolled thyroid disease, hyper-/hypoparathyroidism, or CN VIII compression hearing loss).

Trial design

Design model

Single group

Treatments tested in this trial

  • Denosumab

    Drug

    Active comparator

  • Placebo

    Drug

    Vehicle Placebo

Treatment groups

110 Participants
are divided into 5 treatment groups
Group A: TST002 400 mg Q12WExperimental treatment 1 intervention
Group B: TST002 800 mg Q12WExperimental treatment 1 intervention
Group C: TST002 1200 mg Q12WExperimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention
Group E: DenosumabActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent change from baseline in lumbar spine Bone Mineral Density (BMD)

Lumbar spine (L1-L4) bone mineral density, central imaging read (DXA)

Time frame
Baseline to Week 24

Secondary outcomes

1

Percent change from baseline in lumbar spine Bone Mineral Density (BMD)

Central imaging read (DXA)

Time frame
Weeks 12 and 52
2

Percent change from baseline in total hip Bone Mineral Density (BMD)

Central imaging read (DXA)

Time frame
Weeks 12, 24, and 52
3

Percent change from baseline in femoral neck Bone Mineral Density (BMD)

Central imaging DXA

Time frame
Weeks 12, 24 and 52
4

TST002 plasma concentration

Plasma concentrations at each dosing timepoint

Time frame
Up to 52 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Transcenta Therapeutics (Hangzhou) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

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