Efficacy of Denosumab for Osteoporosis and Its Impact on Sarcopenia
Clinical Controlled Study on the Efficacy of Denosumab in Treating Osteoporosis in the Domestic Population and Its Impact on Sarcopenia-related Outcomes
This study is testing if Denosumab can help improve bone health and muscle strength in older adults with osteoporosis, with or without muscle loss.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Wuhan Union Hospital, China Academic / other |
| Drugs / interventions | Denosumab |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06154707 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of Denosumab in treating osteoporosis and its effects on sarcopenia-related outcomes in a domestic population. Patients diagnosed with postmenopausal or senile osteoporosis, with or without sarcopenia, are randomly assigned to receive either Denosumab or a placebo for 12 months. The study aims to compare the changes in osteoporosis and sarcopenia assessments between the two groups to determine the efficacy of Denosumab. The findings could lead to improved treatment options for individuals suffering from osteoporosis-sarcopenia syndrome.
Who should consider this trial
Good fit: Ideal candidates include postmenopausal or senile individuals diagnosed with osteoporosis, with or without sarcopenia, who have not previously taken anti-osteoporosis medications.
Not a fit: Patients with pathological fractures, severe chronic metabolic diseases, or those who have participated in another clinical trial recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective treatment option for patients suffering from osteoporosis and sarcopenia.
How similar studies have performed: Other studies have shown promise in using Denosumab for osteoporosis treatment, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Wuhan, Hubei
- Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Wen Peng
- Email: pengwen666@sina.com
- Phone: 13986074846
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.