A Comparative Study to Valuating the Efficacy and Safety of QL1206 and Prolia®
Recruiting
Phase 3
Interventional Study
Postmenopausal Women With Osteoporosis at High Risk of Fracture
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 50 – 85
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 278 (estimated)
- Sponsor
- Qilu Pharmaceutical Co., Ltd. · Industry
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About This Trial
This study is a multicenter, randomized, double-blind comparative study to valuating the efficacy and safety of QL1206 and Prolia® in postmenopausal women with osteoporosis at high risk of fracture.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Subjects who agree to participate in the study and sign the informed consent form.
* Postmenopausal women who can walk freely, aged 50-85 years (including 50 and 85 years old).
* Subjects whose absolute value of bone mineral density (BMD) in the lumbar or total hip area meets …
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