Osteoporosis, PostmenopausalPhase 3NCT05215977
Efficacy and Safety of MW031 in PMO Subjects
A Phase 3 study testing MW031 in people with Osteoporosis, Postmenopausal, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
Trial summary
This study is a multicenter, randomized, double-blinded, placebo-controlled Phase III clinical study to evaluate the clinical efficacy and safety of MW031 in Chinese postmenopausal osteoporotic subjects with increased bone fracture risk . Read more about this study
- Who is it for?
- Ages 55 to 80 years, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- MW031
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 448 participants
- Where
- 1 siteChina
- Study dates
- 27 Dec 2019to 27 Sep 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 55 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMD -4.0<T-score ≤-2.5 at either the lumbar spine or total hip or femoral neck
- All subjects must have at least one of following additional the risk factors:history of fracture, parental history of hip fracture, increased bone turnover rate at screening, low body weight, elderly (age≥65year)，current smoker
- Postmenopausal is defined as >2 years postmenopausal, which can be >2 years of spontaneous amenorrhea, or bilateral oophorectomy >2 years after surgery. If bilateral oophorectomy status is unknown, use follicle-stimulating hormone (FSH) levels > 40 mIU/mL to confirm surgical postmenopausal status.
Who cannot join
- Bone/metabolic disease
- Hyperparathyroidism or hypoparathyroidism
- Thyroid condition: Hyperthyroidism or hypothyroidism
- Rheumatoid arthritis
- Malignant tumors
- Malabsorption syndrome
- Oral bisphosphonates
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study, Evaluating the Efficacy and Safety of Recombinant Fully Human Anti-RANKL Monoclonal Antibody in Postmenopausal Osteoporosis Subjects With Increased Bone Fracture Risk
This study is a multicenter, randomized, double-blinded, placebo-controlled Phase III clinical study to evaluate the clinical efficacy and safety of MW031 in Chinese postmenopausal osteoporotic subjects with increased bone fracture risk .
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- MW031, Placebo
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MW031Drug
Also called Recombinant anti-RANKL human monoclonal antibody injection
The active ingredient of MW031 is a recombinant human anti-RANKL monoclonal antibody ,subcutaneous injection of 60 mg (1.0 mL)every 6 months for a maximum of 2 consecutive doses throughout the trial.
Dietary Supplement: Elemental Calcium Oral, at least1000 mg Dietary Supplement: Vitamin D Oral, 400 IU
PlaceboDrug
subcutaneous injection of 60 mg (1.0 mL)every 6 months for a maximum of 2 consecutive doses throughout the trial.
Dietary Supplement: Elemental Calcium Oral, at least1000 mg Dietary Supplement: Vitamin D Oral, 400 IU
| Study group | Role | What they receive |
|---|---|---|
| MW031 | Experimental | MW031 injection(60 mg) was administered subcutaneously once every 6 months for a maximum of 2 consecutive doses throughout the trial, according to the investigator's assessment. Receives: Drug: MW031 |
| placebo | Placebo comparator | Placebo was administered subcutaneously once every 6 months for a maximum of 2 consecutive doses throughout the trial. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine from Baseline up to 12 months
Dual energy x-ray absorptiometry (DXA) is applied for Bone mineral density (BMD) assessment.
Measured: Baseline and Month 12
Secondary outcomes (3)
Percent Change in BMD at the Lumbar Spine from Baseline up to 6 months
Measured: Baseline and Month 6
Percent change in BMD at the total hip, femoral neck from Baseline up to 6 months and 12 months
Measured: Baseline, Month 6 and Month 12
Percent Change in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) and Serum Procollagen Type I N Propeptideserum (s-PINP) from Baseline up to 12 months
Measured: Baseline, Month 1, Month 3, Month 6, Month 9 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start27 Dec 2019
- Primary completion27 Sep 2021
- Study completion27 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- More trials run by Mabwell (Shanghai) Bioscience 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 448 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215977
- Sponsor's protocol ID
- MW031-2019-CP301
- Status last verified
- Oct 2023
- First submitted
- 18 Jan 2022
- Last updated
- 11 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jiang Y, Huo Y, Li Y, Kong X, Wang B, Liu F, Zheng X, Li Y, Yang Y, Xu Y, Xue Q, Hu Z, Xiao Y, Ma W, Guo Y, Yu W, Xia W. Randomized, double-blind, placebo-controlled, multicenter study to evaluate efficacy and safety of the denosumab biosimilar MW031 in Chinese postmenopausal women with osteoporosis. Expert Opin Biol Ther. 2024 Jul;24(7):665-672. doi: 10.1080/14712598.2024.2352587. Epub 2024 May 16.
PubMed 38752402
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study, Evaluating the Efficacy and Safety of Recombinant Fully Human Anti-RANKL Monoclonal Antibody in Postmenopausal Osteoporosis Subjects With Increased Bone Fracture Risk
- ClinicalTrials.gov ID
- NCT05215977
- Acronym / sponsor ID
- MW031-2019-CP301
- Conditions
- Osteoporosis, Postmenopausal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Dec 2019 (actual)
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- 27 Sep 2021 (actual)
- First posted
- 31 Jan 2022 (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.
This study is a multicenter, randomized, double-blinded, placebo-controlled Phase III clinical study to evaluate the clinical efficacy and safety of MW031 in Chinese postmenopausal osteoporotic subjects with increased bone fracture risk .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MW031 | Experimental | Drug: MW031MW031 injection(60 mg) was administered subcutaneously once every 6 months for a maximum of 2 consecutive doses throughout the trial, according to the investigator's assessment. |
| placebo | Placebo comparator | Drug: PlaceboPlacebo was administered subcutaneously once every 6 months for a maximum of 2 consecutive doses throughout the trial. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMD -4.0<T-score ≤-2.5 at either the lumbar spine or total hip or femoral neck
- All subjects must have at least one of following additional the risk factors:history of fracture, parental history of hip fracture, increased bone turnover rate at screening, low body weight, elderly (age≥65year)，current smoker
- Postmenopausal is defined as >2 years postmenopausal, which can be >2 years of spontaneous amenorrhea, or bilateral oophorectomy >2 years after surgery. If bilateral oophorectomy status is unknown, use follicle-stimulating hormone (FSH) levels > 40 mIU/mL to confirm surgical postmenopausal status.
Key exclusion criteria (7 listed)
- Bone/metabolic disease
- Hyperparathyroidism or hypoparathyroidism
- Thyroid condition: Hyperthyroidism or hypothyroidism
- Rheumatoid arthritis
- Malignant tumors
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 |
|---|---|---|
| MW031Also: Recombinant anti-RANKL human monoclonal antibody injectionThe active ingredient of MW031 is a recombinant human anti-RANKL monoclonal antibody ,subcutaneous injection of 60 mg (1.0 mL)every 6 months for a maximum of 2 consecutive doses throughout the trial. Dietary Supplement: Elemental Calcium Oral, at least1000 mg Dietary Supplement: Vitamin D Oral, 400 IU | Drug | MW031 |
| Placebosubcutaneous injection of 60 mg (1.0 mL)every 6 months for a maximum of 2 consecutive doses throughout the trial. Dietary Supplement: Elemental Calcium Oral, at least1000 mg Dietary Supplement: Vitamin D Oral, 400 IU | Drug | placebo |
Primary outcome
Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine from Baseline up to 12 months
Time frame: Baseline and Month 12
Dual energy x-ray absorptiometry (DXA) is applied for Bone mineral density (BMD) assessment.
3 secondary outcomes
Percent Change in BMD at the Lumbar Spine from Baseline up to 6 months
Time frame: Baseline and Month 6
Percent change in BMD at the total hip, femoral neck from Baseline up to 6 months and 12 months
Time frame: Baseline, Month 6 and Month 12
Percent Change in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) and Serum Procollagen Type I N Propeptideserum (s-PINP) from Baseline up to 12 months
Time frame: Baseline, Month 1, Month 3, Month 6, Month 9 and Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2023.
- Derived from this study: PubMed 38752402Jiang Y, Huo Y, Li Y, Kong X, Wang B, Liu F, Zheng X, Li Y, Yang Y, Xu Y, Xue Q, Hu Z, Xiao Y, Ma W, Guo Y, Yu W, Xia W. Randomized, double-blind, placebo-controlled, multicenter study to evaluate efficacy and safety of the denosumab biosimilar MW031 in Chinese postmenopausal women with osteoporosis. Expert Opin Biol Ther. 2024 Jul;24(7):665-672. doi: 10.1080/14712598.2024.2352587. Epub 2024 May 16.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MW031 in people with Osteoporosis, Postmenopausal, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine from Baseline up to 12 months (time frame: Baseline and Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05215977, which also lists 1 linked publication.
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 11 Oct 2023.