Using denosumab to prevent fractures in patients with chronic kidney disease
Denosumab Treatment in Patients With Chronic Kidney Disease (CKD) at High Risk of Fracture: A Prospective, Randomised Controlled Study
This study is testing if the drug denosumab can help prevent fractures in people with chronic kidney disease who are at high risk for bone problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Capital Medical University Academic / other |
| Drugs / interventions | Denosumab |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05692297 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the efficacy and safety of denosumab in preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD) in patients with chronic kidney disease (CKD) who are at high risk of fractures. A cohort of CKD patients with a high fracture risk will be followed for at least 24 months. Participants will be randomly assigned to receive either denosumab or conventional treatment, with various bone metabolic markers and bone mineral density being monitored throughout the study.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with stage 3b-5D chronic kidney disease and a high risk of fractures as assessed by the FRAX tool.
Not a fit: Patients under 18, premenopausal women, or those with contraindications to denosumab will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce fracture risk in CKD patients, improving their quality of life.
How similar studies have performed: Previous studies have shown promising results with denosumab in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥18 years old; * Stage 3b-5D chronic kidney disease; * The 10-year probability of hip fracture assessed by fracture risk assessment tool (FRAX) was \>5%; * Voluntarily signed informed consent. Exclusion Criteria: * Age \< 18 or ≥100 years; * Premenopausal women; * Denosumab was absolutely contraindicated; * Had received denosumab or bisphosphonates therapy; * Tertiary hyperparathyroidism; * Patients with malignant tumor; * Patients at risk for osteonecrosis of the jaw; * Estimated follow-up time ≤12 months.
Where this trial is running
Beijing, Beijing
- Nephrology Department of Beijing Jishuitan Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Dongliang Zhang, Director
- Email: zdlycy@163.com
- Phone: +861058396938
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.