Can a new antibody rebuild bone in osteoporosis?

NCT ID NCT07806331

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

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

45 to 80 years

Sex

Female participants only

Healthy volunteers

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

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

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