Denosumab Treatment in CKD Patients at High Risk of Fracture

Launched by CAPITAL MEDICAL UNIVERSITY · Jan 11, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating how effective and safe a medication called denosumab is for preventing fractures in patients with chronic kidney disease (CKD) who are at high risk of breaking a bone. Denosumab is given as an injection every six months and aims to improve bone health in these patients. The study involves adults aged 18 and older with advanced stages of CKD who have a significant risk of hip fractures. Eligible participants will be monitored for at least two years, during which their bone health and any side effects will be carefully tracked.

If you or a loved one have CKD and are concerned about fractures, this study might be an option to consider. Participants will be randomly assigned to either receive denosumab or continue with standard treatment. Throughout the trial, medical professionals will regularly check various markers related to bone health and will document any health issues that arise. This trial is currently recruiting and aims to provide valuable information about how denosumab could help improve bone density and reduce fracture risk in patients with CKD.

Gender

ALL

Eligibility 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.