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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
RECRUITING
Wuhan
Contact Information
Primary
Wen Peng
pengwen666@sina.com
13986074846
Backup
ShaoTian Li
1398998676@qq.com
18300850090
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2025-03-01
Participants
Target number of participants: 86
Treatments
Experimental: Denosumab Group
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.
Placebo_comparator: Placebo Group
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. The study lasted for 12 months.
Related Therapeutic Areas
Sponsors
Leads: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

This content was sourced from clinicaltrials.gov