NCT05692297

Denosumab Treatment in CKD Patients at High Risk of Fracture

Denosumab Treatment in Patients With Chronic Kidney Disease (CKD) at High Risk of Fracture: A Prospective, Randomised Controlled Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Objective: To verify the efficacy and safety of denosumab in the prevention and treatment of CKD-MBD in CKD patients with high risk of fracture. Methods: A cohort of CKD patients with high risk of fracture was established and followed up for long periods (≥24 months). Patients with CKD3b-5D stage and fracture risk assessment tool (FRAX) scores at high risk or very high risk of fracture were enrolled. A multicenter, prospective, open-label, randomised controlled, interventional study was conducted. The patients were divided into two groups. The patients in the denosumab group received subcutaneous injection of denosumab 60mg once every 6 months, and the patients in the non-denosumab group received conventional treatment. Bone metabolic markers (serum calcium, phosphorus, vitamin D, parathyroid hormone, alkaline phosphatase, tartrate-resistant acid phosphatase 5b, osteocalcin, total N-terminal propeptide of type I collagen, etc.), bone mineral density (dual-energy X-ray, quantitative CT), and vascular calcification score were regularly monitored. All adverse events (all-cause death, cardiovascular death, cardiac events, fracture, hospitalization, emergency department visits, etc.) were recorded during the follow-up period. Bone mineral density and clinical parameters were compared between the two groups.

Conditions

• Chronic Kidney Diseases
• Fracture
• Bone Density, Low
• End Stage Renal Disease

Interventions

Type	Name	Description
DRUG	Denosumab	The patients in the denosumab group received subcutaneous injection of denosumab 60mg once every 6 months for 24 months.
DRUG	Non-denosumab	Taken other medications, such as diphosphonates, active vitamin D and/or active vitamin D analogue, calcimimetics, calcitonin, estrogen receptor agonists, etc.

Timeline

• Start date: 2023-01-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-01-20
• Last updated: 2023-01-25

Locations

1 site across 1 country: China