A Study on Efficacy, Safety and Immunogenicity of 9MW0311 in Postmenopausal Women With Osteoporosis

NCT06804590 | Recruiting Phase 3

• 1 other identifier: 9MW0311-2024-CP302
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postmenopausal Women Osteoporosis

Keywords

Denosumab; efficacy; MW031; postmenopausal women; safety

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline and 12 months

Secondary Outcomes (7)

• Percent Change From Baseline in LS-BMD at Week 27 （Month 6)

  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 )

  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

  Baseline, Month1, Month3, Month6, Month9 and Month 12

• Proportion of subjects with new fragility fractures (e.g., vertebrae, hip, non-vertebrae)

  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

  From baseline to Month12

Study Arms (2)

9MW0311

EXPERIMENTAL

9MW0311 Denosumab injection(60 mg)

Drug: 9MW0311

Prolia®

ACTIVE COMPARATOR

Prolia® Denosumab injection(60 mg)

Drug: Prolia®

Interventions

9MW0311 DRUG

9MW0311 Denosumab injection(60 mg) was administered subcutaneously once every 6 months for a maximum of 2 consecutive doses throughout the trial.

9MW0311

Prolia® DRUG

Prolia® Denosumab injection(60 mg) was administered subcutaneously once every 6 months for a maximum of 2 consecutive doses throughout the trial.

Prolia®

Eligibility Criteria

• Age: 50 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Bone/metabolic disease
• Hyperparathyroidism or hypoparathyroidism
• Thyroid condition: Hyperthyroidism or hypothyroidism
• Rheumatoid arthritis
• Malignant tumors
• Malabsorption syndrome
• 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:

Sponsors & Collaborators

• Mabwell (Shanghai) Bioscience Co., Ltd.: lead

Study Sites (1)

Mabwell (Shanghai) Bioscience Co., Ltd.

Beijing, China

RECRUITING

MeSH Terms

Interventions

Denosumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Zhitian Hu

CONTACT

86-10-87708016; zhitian.hu@Mabwell.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: February 3, 2025
• Study Start: November 16, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)