Can a new antibody rebuild bone in osteoporosis?
NCT ID NCT07806331
First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time
Summary
This phase II trial tests an investigational drug called TST002 in postmenopausal women aged 45 to 80 who have osteoporosis or low bone mass. The study compares three different doses of TST002 against a placebo and an existing osteoporosis drug, denosumab. The main goal is to see whether TST002 can increase bone mineral density in the spine over 24 weeks, with follow-up to one year. Researchers also track safety, side effects, and how the drug behaves in the body.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TST002, an investigational humanized monoclonal antibody given by intravenous infusion
- What this could lead to
- If TST002 works, it could offer a new treatment option to strengthen bones and reduce fracture risk in postmenopausal women with osteoporosis or low bone mass.
- What could go wrong
- This is an early-phase trial with a small number of participants, so the drug may not prove effective or safe. Possible risks include infusion reactions and effects on bone metabolism, which the study will monitor.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 110 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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45 to 80 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Voluntary signed informed consent; able to walk freely; willing/able to complete all study procedures. 2. BMI 18.0-30.0 kg/m² (inclusive); body weight ≥45 kg. 3. Postmenopausal women aged 45-80 years (inclusive) at screening, postmenopausal ≥2 years (≥12 consecutive months without spontaneous vaginal bleeding/spotting). 4. 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). 5. At least 2 contiguous evaluable vertebrae (L1-L4) and at least one evaluable hip for DXA assessment. 6. No disease, per investigator history/exam/workup, likely to significantly affect the study or increase health risk (documented exceptions permitted with justification). Exclusion Criteria: 1. BMD T-score ≤-3.50 at lumbar spine, total hip, or femoral neck at screening. 2. Prior hip fracture. 3. ≥2 vertebral fractures on screening lateral spine X-ray (investigator-assessed). 4. 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). 5. 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. 6. History of TMJ disorder, TMJ osteonecrosis, or atypical fracture. 7. Hypercalcemia or hypocalcemia (albumin-corrected) at screening. 8. Serum 25(OH)D \<20 ng/mL at screening. 9. History of MI, or serious cardiac disease (CAD, NYHA class II-IV heart failure) within 6 months before screening. 10. History of stroke (cerebral infarction, ischemic or hemorrhagic). 11. ALT/AST \>3× ULN; ALP \>2.5× ULN; total bilirubin or creatinine \>1.5× ULN at screening. 12. Multiple myeloma, primary/metastatic bone malignancy, or history of skeletal radiotherapy. 13. 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). 14. Known hypersensitivity to study drug. 15. History of solid organ or bone marrow transplant. 16. Positive HIV, syphilis, HCV antibody, or HBsAg at screening; or HBcAb-positive with detectable HBV DNA. 17. Active tuberculosis within 6 months before screening. 18. Participation in another clinical trial within 30 days or 5 half-lives of the investigational product (whichever longer) before screening. 19. Any other condition the investigator judges unsuitable for participation, a safety risk, or interfering with study assessments/completion.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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