Postmenopausal OsteoporosisPhase 2NCT07806331
Study of TST002 Injection in Postmenopausal Women With Osteoporosis or Low Bone Mass
A Phase 2 study testing Denosumab in people with Postmenopausal Osteoporosis and Low Bone Mass, run by Transcenta Therapeutics (Hangzhou) Co., Ltd..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 80 years, women only
- Conditions the study is for
- Postmenopausal Osteoporosis, Low Bone Mass
- What is being tested?
- Denosumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2026to 31 Oct 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- At least 2 contiguous evaluable vertebrae (L1-L4) and at least one evaluable hip for DXA assessment.
- No disease, per investigator history/exam/workup, likely to significantly affect the study or increase health risk (documented exceptions permitted with justification).
Who cannot join
- 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).
- Prior osteoporosis therapy (incl. trial participation) within protocol-specified washout windows (IV bisphosphonates, oral bisphosphonates, denosumab/cathepsin K inhibitors, tibolone/cinacalcet/calcitonin, teriparatide/PTH analogs, systemic estrogen/SERMs, strontium ranelate/fluoride, hormonal castration therapy, systemic glucocorticoids ≥5 mg/day prednisone-equivalent for >14 days) - see protocol for exact windows per agent.
- History of TMJ disorder, TMJ osteonecrosis, or atypical fracture.
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- Hypercalcemia or hypocalcemia (albumin-corrected) at screening.
- Serum 25(OH)D <20 ng/mL at screening.
- History of MI, or serious cardiac disease (CAD, NYHA class II-IV heart failure) within 6 months before screening.
- History of stroke (cerebral infarction, ischemic or hemorrhagic).
- ALT/AST >3× ULN; ALP >2.5× ULN; total bilirubin or creatinine >1.5× ULN at screening.
- Multiple myeloma, primary/metastatic bone malignancy, or history of skeletal radiotherapy.
- Malignancy within 5 years before screening (except cured skin squamous/basal cell carcinoma or documented cured in situ cervical cancer, no recurrence ≥3 months before dosing).
- Known hypersensitivity to study drug.
- History of solid organ or bone marrow transplant.
- Positive HIV, syphilis, HCV antibody, or HBsAg at screening; or HBcAb-positive with detectable HBV DNA.
- Active tuberculosis within 6 months before screening.
- Participation in another clinical trial within 30 days or 5 half-lives of the investigational product (whichever longer) before screening.
- Any other condition the investigator judges unsuitable for participation, a safety risk, or interfering with study assessments/completion.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-Blind, Parallel-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of TST002 Injection in Postmenopausal Osteoporosis Patients and Middle-Aged to Older Women With Low Bone Mass
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.
Read the detailed description
Primary Purpose: Efficacy and safety evaluation of TST002 in postmenopausal osteoporosis and low bone mass.
Design: 5-arm, randomized, double-blind (denosumab arm open-label), placebo- and active-comparator (denosumab)-controlled, parallel-group study with stratified block randomization 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 (725-1450 IU) supplementation from screening through study end, with an optional vitamin D loading dose for those with baseline 25(OH)D 20-40 ng/mL.
Unblinding: Primary analysis after all participants complete Week 24 is performed by an unblinded CRO team; investigators, participants, and the CRO study team (except for the open-label denosumab arm) remain blinded until final study unblinding
- Conditions
- Postmenopausal Osteoporosis, Low Bone Mass
- Being tested
- Denosumab, Placebo
- Keywords
- TST002, bone mineral density, postmenopausal osteoporosis, low bone mass, sclerostin, monoclonal antibody, DXA
- Medical subject headings
- Osteoporosis, Postmenopausal, Sclerosteosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenosumabDrug
Active comparator
PlaceboDrug
Vehicle Placebo
| Study group | Role | What they receive |
|---|---|---|
| TST002 400 mg Q12W | Experimental | IV infusion 400 mg on D1(W0), W8, W16, W24, W32, W40, W48; placebo infusion at W12, W24, W36, W48 Receives: Drug: Placebo |
| TST002 800 mg Q12W | Experimental | IV infusion 800 mg on D1(W0), W8, W16, W24, W32, W40, W48; placebo infusion at W12, W24, W36, W48 Receives: Drug: Placebo |
| TST002 1200 mg Q12W | Experimental | TST002 1200 mg D1(W0), W12, W24, W36, W48; placebo infusion at W12, W24, W36, W48 Receives: Drug: Placebo |
| Placebo | Placebo comparator | IV placebo on D1(W0), W12, W24, W36, W48; crosses over to open-label TST002 in extension phase (dose per primary analysis) Receives: Drug: Denosumab |
| Denosumab | Active comparator | Denosumab 60 mg subcutaneous injection at D1(W0) and W24 (open-label) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change from baseline in lumbar spine Bone Mineral Density (BMD)
Lumbar spine (L1-L4) bone mineral density, central imaging read (DXA)
Measured: Baseline to Week 24
Secondary outcomes (19)
Percent change from baseline in lumbar spine Bone Mineral Density (BMD)
Central imaging read (DXA)
Measured: Weeks 12 and 52
Percent change from baseline in total hip Bone Mineral Density (BMD)
Central imaging read (DXA)
Measured: Weeks 12, 24, and 52
Percent change from baseline in femoral neck Bone Mineral Density (BMD)
Central imaging DXA
Measured: Weeks 12, 24 and 52
TST002 plasma concentration
Plasma concentrations at each dosing timepoint
Measured: Up to 52 weeks
Percent change from baseline in bone turnover markers
P1NP, β-CTX, OC, BSAP, TRACP-5b, and total sclerostin
Measured: Up to 52 weeks
Anti-drug antibody (ADA) positivity rate
Immunogenicity - proportion positive and time to first positive
Measured: Up to 52 weeks
Incidence of adverse events
AEs, vital signs, physical exam, and clinically significant lab abnormalities (CTCAE v6.0 graded)
Measured: Up to 52 weeks
TST002 Concentration-time
Area under curve (AUC)
Measured: Up to 52 weeks
TST002 Peak Plasma Concentration
Cmax
Measured: Up to 52 weeks
TST002 Trough Concentrations
Ctrough
Measured: Up to 52 weeks
TST002 Half-life
T1/2
Measured: Up to 52 weeks
TST002 Systemic Clearance
CL
Measured: Up to 52 weeks
TST002 Volume of Distribution
Vd
Measured: Out to 52 weeks
TST002 Effects on total Sclerostin
Pharmacodynamic effects
Measured: Up to 52 weeks
TST002 Effects on total P1NP
Pharmacodynamic effects of Serum N-terminal propeptide of procollagen type 1
Measured: Up to 52 weeks
TST002 Effects on total B-CTX
Pharmacodynamic effects of Beta-C-terminal telopeptide
Measured: Out to 52 weeks
TST002 Effects on total OC
Pharmacodynamic effects of osteocalcin
Measured: Out to 52 weeks
TST002 Effects on total BSAP
Pharmacodynamic effects of Bone-specific alkaline phosphatase
Measured: Up to 52 weeks
TST002 Effects on total TRACP-5b
Pharmacodynamic effects of Tartrate-Resistant Acid Phosphatase 5b
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start31 Oct 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Double-blind (Participant, Investigator) TST002 doses or placebo; denosumab arm open-label
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Transcenta Therapeutics (Hangzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806331
- Sponsor's protocol ID
- TST002-1001
- Status last verified
- Sep 2026
- First submitted
- 20 Aug 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Original informed consent forms for trial participants do not explicitly cover secondary research use or broad data sharing