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NCT06898060 | NOT YET RECRUITING | Postmenopausal Women With Osteoporosis

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

Condition or disease

Postmenopausal Women With Osteoporosis

Intervention/treatment

QLG2128

Teriparatide Injection

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 282 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2025-06
Estimated Primary Completion Date : 2027-05
Estimated Study Completion Date : 2027-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years to 85 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
To Evaluate the Efficacy and Safety of Abaloparatide Injection (QLG2128) in the Treatment of Postmenopausal Women With Osteoporosis and at High Risk of Fracture

Location Details

NCT06898060

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How to Participate

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Locations

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