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

PHASE3RecruitingINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

February 1, 2024

Primary Completion Date

December 31, 2024

Study Completion Date

March 1, 2025

Conditions
SarcopeniaOsteoporosisDenosumab
Interventions
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.

Trial Locations (1)

430022

RECRUITING

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

All Listed Sponsors
lead

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

OTHER