Comparing 9MW0311 and Prolia® for osteoporosis in postmenopausal women

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 testing if a new osteoporosis treatment called 9MW0311 works better than Prolia® in helping postmenopausal women in China strengthen their bones and reduce fracture risk.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 278 (estimated)
• Ages: 50 Years to 80 Years
• Sex: Female
• Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd. (Industry-sponsored)
• Drugs / interventions: methotrexate, prednisone
• Locations: 1 site (Beijing)
• Trial ID: NCT06804590 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blinded Phase III clinical study aims to evaluate the efficacy, safety, and immunogenicity of 9MW0311 compared to Prolia® in Chinese postmenopausal women with osteoporosis who are at high risk for fractures. A total of 278 participants will be randomly assigned to receive either treatment every six months for a year. The primary endpoint focuses on the percentage change in bone mineral density (BMD) at the lumbar spine after 12 months. The study seeks to provide insights into the effectiveness of 9MW0311 in improving bone health in this population.

Who should consider this trial

Good fit: Ideal candidates are postmenopausal women aged 50 to 80 with specific osteoporosis risk factors and a BMD T value between -4.0 and -2.5.

Not a fit: Patients with other significant bone or metabolic diseases, or those with certain thyroid or malignant conditions, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new effective treatment option for postmenopausal women with osteoporosis, potentially reducing fracture risk.

How similar studies have performed: Previous studies have shown success with similar treatments for osteoporosis, indicating a promising approach.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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:

  1. parathyroid hormone (PTH) or PTH derivatives, such as teriparatide;
  2. anabolic hormones or testosterone;
  3. glucocorticoids (equivalent dose more than 5mg/ day of prednisone and continuous use for more than 10 days);
  4. Selective estrogen receptor modulators (SERMs), such as raloxifene;
  5. Menopausal hormone therapy (such as estrogen, estrogen + progesterone, tibolone);
  6. Active vitamin D and its analogues (cumulative use of more than 30 days);
  7. Other bone-active drugs include antiepileptic drugs (except benzodiazepines) and heparin;
  8. Long-term systemic use of ketoconazole, adrenocorticotropin (ACTH), aluminum, lithium, protease inhibitors, methotrexate, gonadotropin releasing hormone agonists;
  9. 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.

Where this trial is running

Beijing

• Mabwell (Shanghai) Bioscience Co., Ltd. — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Zhitian Hu

Conditions Postmenopausal Women Osteoporosis; Denosumab; efficacy; MW031; postmenopausal women; safety