Status:
NOT_YET_RECRUITING
To Evaluate the Efficacy and Safety of Abaloparatide Injection (QLG2128) in the Treatment of Postmenopausal Women With Osteoporosis and at High Risk of Fracture
Lead Sponsor:
Qilu Pharmaceutical Co., Ltd.
Conditions:
Postmenopausal Women With Osteoporosis
Eligibility:
All Genders
50-85 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- In addition to postmenopausal osteoporosis, the other diseases affecting bone metabolism；
- History of osteosarcoma；
- History of orthostatic hypotension；
- Currently suffering from active urinary calculus；
- 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.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
282 Patients enrolled
Trial Details
Trial ID
NCT06898060
Start Date
June 1 2025
End Date
May 1 2027
Last Update
March 27 2025
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