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Clinical Controlled Study on the Efficacy of Denosumab in Treating Osteoporosis in the Domestic Population and Its Impact on Sarcopenia-related Outcomes

Clinical Controlled Study on the Efficacy of Denosumab in Treating Osteoporosis in the Domestic Population and Its Impact on Sarcopenia-related Outcomes

Recruiting
40 years and older
All
Phase 3

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Overview

Through the method of a clinical randomized controlled trial, patients meeting the study criteria are randomly assigned to either the Denosumab treatment group or a placebo group. After a treatment period of 12 months, the differences in osteoporosis and sarcopenia-related baseline assessment changes between the two groups are compared. This is to explore the effect of Denosumab in treating osteoporosis and its impact on sarcopenia. The goal is to evaluate the efficacy of Denosumab in treating osteoporosis in the domestic population and its related impact on sarcopenia, with the aim of providing an effective treatment option for the domestic population suffering from 'osteoporosis-sarcopenia syndrome.

Eligibility

Inclusion Criteria:

  • Clinical diagnosis of postmenopausal/senile osteoporosis after examination and assessment.
  • Clinical diagnosis of postmenopausal/senile osteoporosis combined with sarcopenia after examination and assessment.
  • Have not previously taken any other anti-osteoporosis drugs.

Exclusion Criteria:

  • Clinical diagnosis of pathological fractures.
  • Have participated in another clinical trial within the past 3 months or have taken other anti-osteoporosis drugs within the past 6 months.
  • Severe chronic metabolic diseases or serious organ failure.

Study details
    Sarcopenia
    Osteoporosis
    Denosumab

NCT06154707

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

21 October 2025

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