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NCT Number: NCT06898060

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

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.

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

QLG2128

Drug

Recommended dosage is 80 μg subcutaneously once daily,52week

Teriparatide Injection

Drug

Recommended dosage is 20μg subcutaneously once daily,52week

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

zhenlin Zhang, Doctor

CONTACT

[email protected]

13621673716

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2025
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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