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.
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.
In addition to postmenopausal osteoporosis, the other diseases affecting bone metabolism；
History of osteosarcoma；
History of orthostatic hypotension；
Currently suffering from active urinary calculus；
Parallel
QLG2128
DrugRecommended dosage is 80 μg subcutaneously once daily，52week
Teriparatide Injection
DrugRecommended dosage is 20μg subcutaneously once daily，52week
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 52 Week
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 52 Week
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 26 Week
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 26 Week
Percent Change in Bone Mineral Density (BMD) of Total Hip, Femoral Neck From Baseline to 26/52 Week
Percent Change in Bone Mineral Density (BMD) of Total Hip, Femoral Neck From Baseline to 26/52 Week
Proportion of Subjects With New Fragility Fractures From Baseline to 26/52 Week
Proportion of Subjects With New Fragility Fractures From Baseline to 26/52 Week
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
