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NCT06154707

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

Status unknown Phase 3 Last updated 16 August 2024
What this trial tests

Phase 3 trial testing Denosumab Injection in Sarcopenia in 86 participants. Status unknown.

Timeline
1 February 2024
Primary endpoint
31 December 2024
1 March 2025

Quick facts

Lead sponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
PhasePhase 3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment86
Start date1 February 2024
Primary completion31 December 2024
Estimated completion1 March 2025
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

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

Who can join

40 and older, any sex, with Sarcopenia or Osteoporosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Denosumab for Primary Osteoporosis and Its Impact on Sarcopenia in the Chinese Population: Insights from Clinical Evidence and RANKL Pathway Mendelian Randomization.
    Li S, Hu S, Zheng X, Ku X, et al · · 2025 · cited 2× · PMID 41268337 · DOI 10.2147/cia.s547803
  2. Denosumab ameliorates muscle indices in Chinese osteoporosis patients through clinical and bioinformatic evidence of RANKL in sarcopenia.
    Li S, Hu S, Zheng X, Ku X, et al · · 2026 · PMID 41660235 · DOI 10.1016/j.isci.2025.114509

Verify or expand the search:

Other trials of Denosumab Injection

Trials testing the same drug.

Other recruiting trials for Sarcopenia

Currently open trials in the same condition.

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

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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