Postmenopausal Women OsteoporosisPhase 3NCT06804590
A Study on Efficacy, Safety and Immunogenicity of 9MW0311 in Postmenopausal Women With Osteoporosis
A Phase 3 study testing 9MW0311 and Prolia® in people with Postmenopausal Women Osteoporosis, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
Trial summary
This study is a multicenter, randomized, double-blinded, parallel-group Phase III clinical study to compare the clinical efficacy, safety, and immunogenicity of 9MW0311 and Prolia® in Chinese postmenopausal women with osteoporosis at high risk for fracture. Read more about this study
- Who is it for?
- Ages 50 to 80 years, women only
- Conditions the study is for
- Postmenopausal Women Osteoporosis
- What is being tested?
- 9MW0311 and Prolia®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 16 Nov 2024to 30 Jun 2026
- 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 50 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who can walk freely (≥50 and ≤80 years);
- As measured by DXA, the absolute value of BMD at lumbar spine, femoral neck or total hip was -4.0<T value ≤-2.5;
- Subjects must have at least one of the following other risk factors: 1) history of previous fragility fractures; 2) Either or both parents have a history of hip fragility fracture; 3) Increased bone turnover rate during screening; 4) Low body weight; 5) Old age(≥70); 6) Currently smoking.
- The duration of spontaneous amenorrhea was >2 years or >2 years after bilateral oophorectomy. If the status of bilateral oophorectomy is unknown or if the ovaries are preserved after hysterectomy, follicle stimulating hormone (FSH) levels >40mIU/mL may be used to confirm the status of postoperative menopause.
Who cannot join
- Bone/metabolic disease
- Hyperparathyroidism or hypoparathyroidism
- Thyroid condition: Hyperthyroidism or hypothyroidism
- Rheumatoid arthritis
- Malignant tumors
- Malabsorption syndrome
Show all 25Show fewer
- Liver cirrhosis, active hepatitis B or hepatitis C, and unstable liver disease; serum aspartate aminotransferase and alanine aminotransferase ≥ 2.0 times the upper limit of normal (ULN); alkaline phosphatase or total bilirubin ≥ 1.5 ULN;
- Renal disease - severe impairment of kidney function
- Clinically significant cardiovascular and cerebrovascular diseases (such as myocardial infarction, unstable angina or stroke, NYHA class III or IV heart failure in the 12 months prior to screening) and hematopoietic system disease judged by the investigator;
- Hypercalcemia or hypocalcemia ;
- vitamin D deficiency (25-hydroxyvitamin D, 25OHD <20 ng/mL);
- Oral or dental diseases: previous or current evidence of mandibular osteomyelitis or osteonecrosis; Acute dental or mandibular disease requiring oral surgery; Planning invasive dental surgery; Failure to recover from dental or oral surgery;
- Use of intravenous bisphosphonates within the previous 2 years;
- oral bisphosphonates (used for at least 2 years, or used for less than 2 years but more than 3 months, with the last use occurring <1 year before the screening);
- Use of any of the following drugs within 6 weeks prior to screening that may affect bone metabolism:
- parathyroid hormone (PTH) or PTH derivatives, such as teriparatide;
- anabolic hormones or testosterone;
- glucocorticoids (equivalent dose more than 5mg/ day of prednisone and continuous use for more than 10 days);
- Selective estrogen receptor modulators (SERMs), such as raloxifene;
- Menopausal hormone therapy (such as estrogen, estrogen + progesterone, tibolone);
- Active vitamin D and its analogues (cumulative use of more than 30 days);
- Other bone-active drugs include antiepileptic drugs (except benzodiazepines) and heparin;
- Long-term systemic use of ketoconazole, adrenocorticotropin (ACTH), aluminum, lithium, protease inhibitors, methotrexate, gonadotropin releasing hormone agonists;
- Chinese patent medicines for osteoporosis related treatment are clearly described in the instructions, such as Xianling Gubao capsule (tablet), Gushukang capsule (granule), Jintiange capsule and Qianggu capsule."
- History of more than two vertebral fractures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Parallel-group, Phase III Study to Compare the Clinical Efficacy, Safety, and Immunogenicity of Denosumab Injection 9MW0311 With Prolia® in Postmenopausal Women With Osteoporosis
This study is a multicenter, randomized, double-blinded, parallel-group Phase III clinical study to compare the clinical efficacy, safety, and immunogenicity of 9MW0311 and Prolia® in Chinese postmenopausal women with osteoporosis at high risk for fracture.
Read the detailed description
278 patients are randomized 1:1 to receive 9MW0311 and Prolia® every 6 months for 12 months. The primary efficacy endpoint is the percentage change from baseline in BMD at the lumbar spine(LS) in month 12.
- Conditions
- Postmenopausal Women Osteoporosis
- Being tested
- 9MW0311, Prolia®
- Keywords
- Denosumab, efficacy, MW031, postmenopausal women, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
9MW0311Drug
9MW0311 Denosumab injection(60 mg) was administered subcutaneously once every 6 months for a maximum of 2 consecutive doses throughout the trial.
Prolia®Drug
Prolia® Denosumab injection(60 mg) was administered subcutaneously once every 6 months for a maximum of 2 consecutive doses throughout the trial.
| Study group | Role | What they receive |
|---|---|---|
| 9MW0311 | Experimental | 9MW0311 Denosumab injection(60 mg) Receives: Drug: 9MW0311 |
| Prolia® | Active comparator | Prolia® Denosumab injection(60 mg) Receives: Drug: Prolia® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in lumbar spine(LS)-BMD at Week 53 （Month 12)
Percent Change From Baseline in LS-BMD at Week 53 （Month 12)
Measured: Baseline and 12 months
Secondary outcomes (7)
Percent Change From Baseline in LS-BMD at Week 27 （Month 6)
Percent Change From Baseline in LS-BMD at Week 27 （Month 6)
Measured: Baseline and Month 6
Percent change in BMD at the total hip, femoral neck from Baseline up to week 27 (Month 6) and Week 53 (Month 12 )
Percent change in BMD at the total hip, femoral neck from Baseline up to week 27 (Month 6) and Week 53 (Month 12 )
Measured: Baseline, Month6 and Month 53
Percent Change in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) and Serum type I procollagen N-terminal propeptide (s-PINP) from Baseline up to 12 months
Percent Change in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) and Serum type I procollagen N-terminal propeptide (s-PINP) from Baseline up to 12 months
Measured: Baseline, Month1, Month3, Month6, Month9 and Month 12
Proportion of subjects with new fragility fractures (e.g., vertebrae, hip, non-vertebrae)
Proportion of subjects with new fragility fractures (e.g., vertebrae, hip, non-vertebrae)
Measured: From baseline to Month12
Number of participants with AE, SAE, with abnormal vital signs, abnormal physical examination findings, abnormal oral examination findings, abnormal laboratory tests results and abnormal 12-lead ECG readings
AE, SAE, vital signs, physical examination, oral examination, laboratory examination (blood routine, urine routine/urine sediment, blood biochemistry, coagulation function), 12-lead ECG
Measured: From baseline to Month12
ADA positive rate and ADA titer (if applicable)
ADA positive rate and ADA titer (if applicable)
Measured: Baseline and Month 1, Month3, Month6, Month12
NAb positive rate (if applicable)
NAb positive rate (if applicable)
Measured: Baseline and Month 1, Month3, Month6, Month12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start16 Nov 2024
- Primary completion24 Apr 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal Women OsteoporosisStudies 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
- 280 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
- NCT06804590
- Sponsor's protocol ID
- 9MW0311-2024-CP302
- Status last verified
- Aug 2026
- First submitted
- 9 Dec 2024
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel-group, Phase III Study to Compare the Clinical Efficacy, Safety, and Immunogenicity of Denosumab Injection 9MW0311 With Prolia® in Postmenopausal Women With Osteoporosis
- ClinicalTrials.gov ID
- NCT06804590
- Acronym / sponsor ID
- 9MW0311-2024-CP302
- Conditions
- Postmenopausal Women Osteoporosis
- Keywords
- Denosumab, efficacy, MW031, postmenopausal women, safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Nov 2024 (actual)
- Primary completion
- 24 Apr 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 3 Feb 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.
This study is a multicenter, randomized, double-blinded, parallel-group Phase III clinical study to compare the clinical efficacy, safety, and immunogenicity of 9MW0311 and Prolia® in Chinese postmenopausal women with osteoporosis at high risk for fracture.
Detailed description
278 patients are randomized 1:1 to receive 9MW0311 and Prolia® every 6 months for 12 months. The primary efficacy endpoint is the percentage change from baseline in BMD at the lumbar spine(LS) in month 12.
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 |
|---|---|---|
| 9MW0311 | Experimental | Drug: 9MW03119MW0311 Denosumab injection(60 mg) |
| Prolia® | Active comparator | Drug: Prolia®Prolia® Denosumab injection(60 mg) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women who can walk freely (≥50 and ≤80 years);
- As measured by DXA, the absolute value of BMD at lumbar spine, femoral neck or total hip was -4.0<T value ≤-2.5;
- Subjects must have at least one of the following other risk factors: 1) history of previous fragility fractures; 2) Either or both parents have a history of hip fragility fracture; 3) Increased bone turnover rate during screening; 4) Low body weight; 5) Old age(≥70); 6) Currently smoking.
- The duration of spontaneous amenorrhea was >2 years or >2 years after bilateral oophorectomy. If the status of bilateral oophorectomy is unknown or if the ovaries are preserved after hysterectomy, follicle stimulating hormone (FSH) levels >40mIU/mL may be used to confirm the status of postoperative menopause.
Key exclusion criteria (25 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 |
|---|---|---|
| 9MW03119MW0311 Denosumab injection(60 mg) was administered subcutaneously once every 6 months for a maximum of 2 consecutive doses throughout the trial. | Drug | 9MW0311 |
| Prolia®Prolia® Denosumab injection(60 mg) was administered subcutaneously once every 6 months for a maximum of 2 consecutive doses throughout the trial. | Drug | Prolia® |
Primary outcome
Percent Change From Baseline in lumbar spine(LS)-BMD at Week 53 （Month 12)
Time frame: Baseline and 12 months
Percent Change From Baseline in LS-BMD at Week 53 （Month 12)
7 secondary outcomes
Percent Change From Baseline in LS-BMD at Week 27 （Month 6)
Time frame: Baseline and Month 6
Percent change in BMD at the total hip, femoral neck from Baseline up to week 27 (Month 6) and Week 53 (Month 12 )
Time frame: Baseline, Month6 and Month 53
Percent Change in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) and Serum type I procollagen N-terminal propeptide (s-PINP) from Baseline up to 12 months
Time frame: Baseline, Month1, Month3, Month6, Month9 and Month 12
Proportion of subjects with new fragility fractures (e.g., vertebrae, hip, non-vertebrae)
Time frame: From baseline to Month12
Number of participants with AE, SAE, with abnormal vital signs, abnormal physical examination findings, abnormal oral examination findings, abnormal laboratory tests results and abnormal 12-lead ECG readings
Time frame: From baseline to Month12
ADA positive rate and ADA titer (if applicable)
Time frame: Baseline and Month 1, Month3, Month6, Month12
NAb positive rate (if applicable)
Time frame: Baseline and Month 1, Month3, Month6, Month12
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 7 Aug 2026.
- 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 9MW0311 and Prolia® in people with Postmenopausal Women Osteoporosis, 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 4 inclusion and 25 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 7 Aug 2026. 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. 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 From Baseline in lumbar spine(LS)-BMD at Week 53 （Month 12) (time frame: Baseline and 12 months). 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 7 Aug 2026.