Postmenopausal Women With Osteoporosis
Conditions
Brief summary
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.
Interventions
DRUGQLG2128
Recommended dosage is 80 μg subcutaneously once daily，52week
DRUGTeriparatide Injection
Recommended dosage is 20μg subcutaneously once daily，52week
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 52 Week | Baseline to 52 Week | Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 52 Week |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 26 Week | 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 | 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 | Baseline to 26/52 Week | Proportion of Subjects With New Fragility Fractures From Baseline to 26/52 Week |
Contacts
Primary Contactzhenlin Zhang, Doctor
Outcome results
None listed