To Evaluate the Efficacy and Safety of Abaloparatide Injection (QLG2128) in the Treatment of Postmenopausal Women With Osteoporosis and at High Risk of Fracture
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QLG2128, Teriparatide Injection.
- Who it may be relevant to
- Registry conditions: Postmenopausal Women With Osteoporosis. Basic parameters: 50 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Randomized, Open-label, Parallel Controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of Abaloparatide Injection (QLG2128) in the Treatment of Postmenopausal Women With Osteoporosis and at High Risk of Fracture
Overview
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 QLG2128
Recommended dosage is 80 μg subcutaneously once daily，52week - Drug Teriparatide Injection
Recommended dosage is 20μg subcutaneously once daily，52week
Primary outcome measures
- Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 52 Week [Time frame: Baseline to 52 Week]
Secondary outcome measures (3)
- 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 Total Hip, Femoral Neck 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 [Time frame: Baseline to 26/52 Week]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06898060 · QLG2128-301