About this trial
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
Qualifiers
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.
Disqualifiers
In addition to postmenopausal osteoporosis, the other diseases affecting bone metabolism;
History of osteosarcoma;
History of orthostatic hypotension;
Currently suffering from active urinary calculus;
Trial design
Treatments tested in this trial
- QLG2128
- Teriparatide Injection