Comparing the Safety and Effectiveness of QL1206 and Prolia in Women With Postmenopausal Osteoporosis at High Fracture Risk

What this Trial Is About

Researchers are evaluating the efficacy and safety of two drugs, QL1206 and Prolia4, in postmenopausal women with osteoporosis who are at high risk of fractures. This multicenter, randomized, double-blind study aims to compare these treatments to understand their effects on bone health. It is a Phase 3 trial sponsored by Qilu Pharmaceutical Co., Ltd., focusing on women aged 50 to 85 years with specific bone density measurements and risk factors for fractures. Participants receive either QL1206 or Prolia4 denosumab injections at a dose of 60 mg. These injections are given subcutaneously once every 6 months, for a maximum of two doses during the trial. The study groups are randomly assigned and masked so that neither participants nor researchers know which treatment is given. This design helps provide a clear comparison of the two drugs. During the study, participants will have their bone mineral density BMD measured at the lumbar spine at the start and after 12 months to assess changes. Researchers will monitor safety and treatment effects throughout the trial. Women who join will be asked to attend scheduled visits for injections and assessments. The study is expected to continue until January 2027, providing detailed information on these treatments impact on osteoporosis in this population.

A Comparative Study to Valuating the Efficacy and Safety of QL1206 and Prolia®