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: Phase 3
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Sarcopenia
• Osteoporosis
• Denosumab

Interventions

Type	Name	Description
DRUG	Denosumab Injection	Denosumab injection 60mg (1.0ml/ branch, Jiangsu Taikang Biological Medicine Co., LTD., s20233111), once every 6 months, 60mg, subcutaneous injection, at the same time to supplement calcium and vitamin D.
OTHER	Normal saline injection (1.0ml/ branch)	Placebo drug, the main component of normal saline injection (1.0ml/ dose). In addition to the different production batch number, its appearance, character, specification, administration mode and frequency are exactly the same as the experimental group of drugs (different production batch number is convenient for later unblinding reference). Take calcium and vitamin D supplements.

Timeline

• Start date: 2024-02-01
• Primary completion: 2024-12-31
• Completion: 2025-03-01
• First posted: 2023-12-04
• Last updated: 2024-08-16

Locations

1 site across 1 country: China