Actively Recruiting

Phase 3
Age: 50Years - 80Years
FEMALE
ID06804590

A Randomized, Double-blind, Parallel-group Study Comparing the Clinical Efficacy, Safety, and Immunogenicity of Denosumab Injection 9MW0311 With Prolia® in Postmenopausal Women With Osteoporosis

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

278

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the clinical efficacy, safety, and immune response of the drug 9MW0311 compared to Prolia® in Chinese postmenopausal women with osteoporosis who are at high risk for fractures. This Phase III, multicenter, randomized, double-blind study aims to better understand how these treatments affect bone density over a year. The study focuses on women aged 50 to 80 years with osteoporosis and additional risk factors for fractures. Participants are randomly assigned to one of two groups to receive either 9MW0311 or Prolia®, both given as a 60 mg denosumab injection under the skin every six months for a total of two doses over 12 months. The main goal is to measure the percentage change in bone mineral density (BMD) of the lumbar spine after one year. Secondary measures include changes in BMD at other bone sites, bone turnover markers, fracture occurrence, and assessment of any side effects or immune reactions. Throughout the study, participants will undergo bone density scans, blood tests for bone markers and immune response, and monitoring for fractures and adverse events at various time points up to 12 months. Safety assessments include vital signs, physical and oral exams, lab tests, and heart monitoring. The study tracks participants' health and treatment effects carefully to evaluate both drugs' performance and tolerability over the course of the year.

CONDITIONS

Brief 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...

  • Female participants aged between 50 and 80 years
  • Ability to walk freely
  • Bone mineral density T value between -4.0 and -2.5 at lumbar spine, femoral neck, or total hip as measured by DXA
  • At least one additional risk factor such as previous fragility fracture, family history of hip fracture, increased bone turnover, low body weight, age 70 or older, or current smoking
  • Duration of spontaneous amenorrhea more than 2 years or more than 2 years after bilateral oophorectomy, or FSH levels above 40mIU/mL if ovarian status is unclear
Not Eligible

You will not qualify if you...

  • Presence of bone or metabolic diseases other than osteoporosis
  • Hyperparathyroidism or hypoparathyroidism
  • Thyroid disorders including hyperthyroidism or hypothyroidism
  • Rheumatoid arthritis
  • Malignant tumors
  • Malabsorption syndrome
  • Severe liver diseases or unstable liver conditions with elevated liver enzymes
  • Severe kidney impairment
  • Significant cardiovascular or cerebrovascular diseases within the past 12 months
  • Abnormal calcium levels (hypercalcemia or hypocalcemia)
  • Vitamin D deficiency (25OHD less than 20 ng/mL)
  • Current or past oral or dental diseases requiring surgery, or failure to recover from dental surgery
  • Use of intravenous bisphosphonates within the past 2 years
  • Use of oral bisphosphonates under specific duration and timing criteria
  • Use of bone metabolism-affecting drugs within 6 weeks prior to screening including parathyroid hormone, anabolic hormones, glucocorticoids, selective estrogen receptor modulators, menopausal hormone therapy, active vitamin D and analogues, antiepileptic drugs (except benzodiazepines), heparin, ketoconazole, ACTH, aluminum, lithium, protease inhibitors, methotrexate, gonadotropin releasing hormone agonists, and certain Chinese patent medicines for osteoporosis
  • History of more than two vertebral fractures

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 months

Participants receive subcutaneous injections of either 9MW0311 or Prolia® every 6 months for up to 12 months.

2 treatment visits (in-person) at 6-month intervals

Follow-up

Duration - 12 months

Participants are monitored for safety, immunogenicity, and bone mineral density changes up to 12 months after starting treatment.

Multiple visits at Baseline, Month 1, Month 3, Month 6, Month 9, and Month 12

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

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Frequently Asked Questions

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