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

What Was Tested

This registered phase 3 trial tested Teriparatide.

It had two arms (groups): QLG2128 (experimental) and Teriparatide Injection (active comparator).

The registry classes the interventions as drug.

Who Took Part

282 planned participants were the target.

It was open to people of any sex aged from 50 years up to 85 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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 with at least 2 consecutive vertebrae(L1 to L4) and at least 1 hip can be evaluated for BMD.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: in addition to postmenopausal osteoporosis, the other diseases affecting bone metabolism；; history of osteosarcoma；; history of orthostatic hypotension；.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Teriparatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Teriparatide study did not mask who received what.

It started in 2025-06 with completion listed for 2027-05.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 52 Week (time frame: Baseline to 52 Week).

It also tracked 3 secondary outcomes, for example Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 26 Week, Percent Change in Bone Mineral Density (BMD) of Total Hip, Femoral Neck From Baseline to 26/52 Week and Proportion of Subjects With New Fragility Fractures From Baseline to 26/52 Week.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Teriparatide in 282 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Teriparatide compound page, all human trials.