NCT06898060Not yet recruitingPhase 3
To Evaluate the Efficacy and Safety of Abaloparatide Injection (QLG2128) in the Treatment of Postmenopausal Women With Osteoporosis and at High Risk of Fracture
A Multicenter, Randomized, Open-label, Parallel Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of Abaloparatide Injection (QLG2128) in the Treatment of Postmenopausal Women With Osteoporosis and at High Risk of Fracture
Source: ClinicalTrials.gov · Last updated 27 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The purpose of this study is to evaluate the efficacy and safety of QLG2128 in the treatment of postmenopausal women with osteoporosis and at high risk of fracture.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 282 (estimated)
- First submitted
- 20 Mar 2025
- Start date
- Jun 2025
- Primary completion date
- May 2027
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Diseases
- Osteoporosis
- NCT number
- NCT06898060
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 282
- From Jun 2025 to the primary completion date, May 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received anti-osteoporosis treatment that does not meet protocol requirements；
- Received medication that affects bone metabolism within 4 weeks prior to screening, or is planned to use prohibited drugs/non-drug therapy under the protocol during the study period.
Other illness
- In addition to postmenopausal osteoporosis, the other diseases affecting bone metabolism；
- History of osteosarcoma；
- History of orthostatic hypotension；
Other
- Currently suffering from active urinary calculus；
Who the study is looking for
- Postmenopausal women who can walk freely (≥50 and ≤85 years);
- The patient has a body mass index(BMI) of 17.0 kg/m2 to 30 kg/m2；
- The patient has a bone mineral density T-score≤-2.5 and \> -5.0 at the lumbar spine (L1-L4) or femoral neck or total hip by dual energy x-ray absorptiometry (DXA)；
- The patient has at least one of the following high risk factors of fracture: 1) history of previous fragility fractures; 2) family history of hip fragility fracture; 3) age≥70 years; 4) BMI≤19.0 kg/m2；5) Currently smoking.
- The patient with at least 2 consecutive vertebrae(L1 to L4) and at least 1 hip can be evaluated for BMD.
Age in the registry: 50 years to 85 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.