Postmenopausal Women With OsteoporosisPhase 3NCT06898060
To Evaluate the Efficacy and Safety of Abaloparatide Injection (QLG2128) in the Treatment of Postmenopausal Women With Osteoporosis and at High Risk of Fracture
A Phase 3 study testing QLG2128 and Teriparatide Injection in people with Postmenopausal Women With Osteoporosis, run by Qilu Pharmaceutical Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Postmenopausal Women With Osteoporosis
- What is being tested?
- QLG2128 and Teriparatide Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to May 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Conditions
- Postmenopausal Women With Osteoporosis
- Being tested
- QLG2128, Teriparatide Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLG2128Drug
Recommended dosage is 80 μg subcutaneously once daily，52week
Teriparatide InjectionDrug
Recommended dosage is 20μg subcutaneously once daily，52week
| Study group | Role | What they receive |
|---|---|---|
| QLG2128 | Experimental | Not described Receives: Drug: QLG2128 |
| Teriparatide Injection | Active comparator | Not described Receives: Drug: Teriparatide Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 52 Week
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 52 Week
Measured: Baseline to 52 Week
Secondary outcomes (3)
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 26 Week
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 26 Week
Measured: Baseline to 26 Week
Percent Change in Bone Mineral Density (BMD) of Total Hip, Femoral Neck From Baseline to 26/52 Week
Percent Change in Bone Mineral Density (BMD) of Total Hip, Femoral Neck From Baseline to 26/52 Week
Measured: Baseline to 26/52 Week
Proportion of Subjects With New Fragility Fractures From Baseline to 26/52 Week
Proportion of Subjects With New Fragility Fractures From Baseline to 26/52 Week
Measured: Baseline to 26/52 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study startJun 2025 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal Women With OsteoporosisStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 282 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898060
- Sponsor's protocol ID
- QLG2128-301
- Status last verified
- Mar 2025
- First submitted
- 20 Mar 2025
- Last updated
- 27 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06898060
- Acronym / sponsor ID
- QLG2128-301
- Conditions
- Postmenopausal Women With Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 282 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2025 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QLG2128 | Experimental | Drug: QLG2128 |
| Teriparatide Injection | Active comparator | Drug: Teriparatide Injection |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QLG2128Recommended dosage is 80 μg subcutaneously once daily，52week | Drug | QLG2128 |
| Teriparatide InjectionRecommended dosage is 20μg subcutaneously once daily，52week | Drug | Teriparatide Injection |
Primary outcome
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
3 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 Total Hip, Femoral Neck 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
Time frame: Baseline to 26/52 Week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
Related trials for Postmenopausal Women With Osteoporosis
Not yet recruiting
Effects of Sensorimotor Balance Training vs Digitally Augmented Core Stabilization in Women With Osteoporosis
Postmenopausal Osteoporosis
Not yet recruitingPhase 2
Study of TST002 Injection in Postmenopausal Women With Osteoporosis or Low Bone Mass
Postmenopausal Osteoporosis, Low Bone Mass
Not yet recruitingPhase 4
Sequential Treatment With Romosozumab Followed by Denosumab vs. Zoledronic Acid for Gains in HIP BMD
Osteoporosis in Post-menopausal Women
Not yet recruiting
High-Intensity Laser Therapy and Physiotherapy for Bone Health in Postmenopausal Women: A Randomized Trial
Osteoporosis, Postmenopausal, Osteopenia
RecruitingObservational study
Sequential Therapies After Osteoanabolic Treatment
Osteoporosis, Postmenopausal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QLG2128 and Teriparatide Injection in people with Postmenopausal Women With Osteoporosis, run by Qilu Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact zhenlin Zhang, Doctor (13621673716, zzl2002@medmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Bone Mineral Density (BMD) of Lumbar Spine From Baseline to 52 Week (time frame: Baseline to 52 Week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.