To Evaluate the Efficacy and Safety of Abaloparatide Injection (QLG2128) in the Treatment of Postmenopausal Women With Osteoporosis and at High Risk of Fracture

Launched by QILU PHARMACEUTICAL CO., LTD. · Mar 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called Abaloparatide (QLG2128) to see how well it works and how safe it is for postmenopausal women who have osteoporosis and are at high risk for fractures. Osteoporosis is a condition that weakens bones, making them more likely to break. The trial is specifically looking for women aged 50 to 85 who can walk independently and have certain bone health measurements indicating they are at risk for fractures. For example, eligible participants need to have a specific level of bone density and at least one factor that increases their fracture risk, such as a history of past fractures or being over 70 years old.

If you or someone you know is interested in participating in this trial, it’s important to know that the study is not yet recruiting participants, so you would need to wait until it starts. Participants will receive the injection of the study medication and will be monitored for safety and effectiveness. There are some health conditions and recent treatments that would exclude someone from joining, so it’s essential to discuss personal health history with a doctor. Overall, this trial aims to find a new way to help improve bone health in women who are particularly vulnerable to fractures.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.