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

Qilu Pharmaceutical

Status and phase

Not yet enrolling

Phase 3

Conditions

Postmenopausal Women With Osteoporosis

Treatments

Drug: Teriparatide Injection

Drug: QLG2128

Study type

Interventional

Funder types

Industry

Identifiers

NCT06898060

QLG2128-301

Details and patient eligibility

About

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.

Enrollment

282 estimated patients

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

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.