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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50-85
SponsorQilu Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

In addition to postmenopausal osteoporosis, the other diseases affecting bone metabolism;

History of osteosarcoma;

History of orthostatic hypotension;

Currently suffering from active urinary calculus;

Trial design

Treatments tested in this trial

  • QLG2128
  • Teriparatide Injection

Treatment groups

282 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators