Actively Recruiting

Phase 3
Age: 50Years - 80Years
FEMALE
NCT06804590

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

Led by Mabwell (Shanghai) Bioscience Co., Ltd. · Updated on 2025-02-03

278

Participants Needed

1

Research Sites

88 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 50Years - 80Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 50 to 80 years who can walk freely
  • Bone mineral density (BMD) T value between -4.0 and -2.5 at lumbar spine, femoral neck or total hip by DXA
  • At least one of the following risk factors: history of fragility fractures, parent(s) with hip fracture history, increased bone turnover, low body weight, age 70 or older, or current smoking
  • Spontaneous amenorrhea for more than 2 years or more than 2 years after bilateral oophorectomy; if ovaries status unclear, follicle stimulating hormone (FSH) level over 40 mIU/mL to confirm menopause
Not Eligible

You will not qualify if you...

  • Bone or metabolic diseases other than osteoporosis
  • Hyperparathyroidism or hypoparathyroidism
  • Hyperthyroidism or hypothyroidism
  • Rheumatoid arthritis
  • Malignant tumors
  • Malabsorption syndrome
  • Liver diseases such as cirrhosis, active hepatitis B or C, or unstable liver disease; elevated liver enzymes (AST/ALT ≥2 times upper limit), alkaline phosphatase or bilirubin ≥1.5 upper limit
  • Severe kidney impairment
  • Significant cardiovascular or cerebrovascular diseases in past 12 months, or blood disorders
  • Hypercalcemia or hypocalcemia
  • Vitamin D deficiency (25OHD <20 ng/mL)
  • Oral or dental diseases including history or current jaw bone infection or necrosis, acute dental disease needing surgery, planned invasive dental surgery, or incomplete healing from dental surgery
  • Use of intravenous bisphosphonates in past 2 years
  • Use of oral bisphosphonates for at least 2 years, or used 3+ months but less than 2 years with last use under 1 year before screening
  • Use within 6 weeks before screening of drugs affecting bone metabolism including parathyroid hormone or derivatives, anabolic hormones, glucocorticoids over 5 mg prednisone equivalent for over 10 days, selective estrogen receptor modulators, menopausal hormone therapy, active vitamin D over 30 days cumulative use, certain bone-active drugs, long-term use of ketoconazole, ACTH, aluminum, lithium, protease inhibitors, methotrexate, gonadotropin releasing hormone agonists, or specific Chinese patent medicines for osteoporosis
  • History of more than two vertebral fractures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mabwell (Shanghai) Bioscience Co., Ltd.

Beijing, China

Actively Recruiting

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Research Team

Z

Zhitian Hu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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