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

NCT06898060 | Not Yet Recruiting Phase 3

• 1 other identifier: QLG2128-301
• Study Type: interventional
• Target: 282
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postmenopausal Women With Osteoporosis

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline to 52 Week

Secondary Outcomes (3)

• 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 Total Hip, Femoral Neck From Baseline to 26/52 Week

  Baseline to 26/52 Week

• Proportion of Subjects With New Fragility Fractures From Baseline to 26/52 Week

  Baseline to 26/52 Week

Study Arms (2)

QLG2128

EXPERIMENTAL

Drug: QLG2128

Teriparatide Injection

ACTIVE COMPARATOR

Drug: Teriparatide Injection

Interventions

QLG2128 DRUG

Recommended dosage is 80 μg subcutaneously once daily，52week

QLG2128

Teriparatide Injection DRUG

Recommended dosage is 20μg subcutaneously once daily，52week

Teriparatide Injection

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

MeSH Terms

Interventions

Teriparatide

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

zhenlin Zhang, Doctor

CONTACT

13621673716; zzl2002@medmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 27, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 27, 2025

Record last verified: 2025-03