DRUG
QLG2128
Recommended dosage is 80 μg subcutaneously once daily,52week
Status
Not yet recruiting
Phase
Phase 3
Enrollment
282
Locations
0
Results
Not posted
Publications
0
Study 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
DRUG
Recommended dosage is 80 μg subcutaneously once daily,52week
DRUG
Recommended dosage is 20μg subcutaneously once daily,52week
Timeline
First posted
Mar 27, 2025
Study start
Jun 2025
Primary completion
May 2027
Study completion
May 2027
Results posted
Not reported
Registry updated
Mar 27, 2025
Outcomes
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 52 Week
Time frame · 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
Time frame · 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
Time frame · 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
Time frame · Baseline to 26/52 Week
Proportion of Subjects With New Fragility Fractures From Baseline to 26/52 Week
Eligibility
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.
Study locations
No country data reported. Showing up to 24 locations stored in the fast local snapshot.
No study locations reported.
Publications
No PMID-linked publications were present in this registry snapshot.
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