To Evaluate the Efficacy and Safety of Abaloparatide Injection (QLG2128) in the Treatment of Postmenopausal Women With Osteoporosis and at High Risk of Fracture

Phase 3

Not yet recruiting

• Conditions: Postmenopausal Women With Osteoporosis
• Interventions: Drug: QLG2128; Drug: Teriparatide Injection

• Registration Number: NCT06898060
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-20
• Study First Submitted QC: 2025-03-20
• Last Update Submitted: 2025-03-20
• Study First Posted: 2025-03-27
• Last Update Posted: 2025-03-27
• Study Start: 2025-06
• Primary Completion: 2027-05
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 282

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QLG2128	QLG2128	-
Teriparatide Injection	Teriparatide Injection	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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