Current partner codePEPTIDESDE
NCT06898060·Phase 3·INTERVENTIONAL

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

Status

Not yet recruiting

Phase

Phase 3

Enrollment

282

Locations

0

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

QLG2128

Recommended dosage is 80 μg subcutaneously once daily,52week

DRUG

Teriparatide Injection

Recommended dosage is 20μg subcutaneously once daily,52week

Timeline

From registration to results.

  1. First posted

    Mar 27, 2025

  2. Study start

    Jun 2025

  3. Primary completion

    May 2027

  4. Study completion

    May 2027

  5. Results posted

    Not reported

  6. Registry updated

    Mar 27, 2025

Outcomes

What the study measures.

Primary outcomes

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

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

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

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

Eligibility

Who can take part.

Minimum age
50 Years
Maximum age
85 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Teriparatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.