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
Trial Information
Current as of April 26, 2025
Not yet recruiting
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.
About Qilu Pharmaceutical Co., Ltd.
Qilu Pharmaceutical Co., Ltd. is a leading biopharmaceutical company based in China, dedicated to the research, development, manufacturing, and commercialization of innovative therapeutic solutions. With a strong emphasis on quality and efficacy, Qilu specializes in a diverse range of therapeutic areas, including oncology, cardiovascular diseases, and central nervous system disorders. The company is committed to advancing healthcare through cutting-edge clinical trials and a robust pipeline of new drugs, leveraging its state-of-the-art facilities and a talented team of professionals. Qilu Pharmaceutical aims to improve patient outcomes globally by delivering high-quality pharmaceuticals that meet the evolving needs of the healthcare market.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported