Denosumab Treatment in CKD Patients at High Risk of Fracture

Capital Medical University102 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

102

Conditions

Chronic Kidney Diseases

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Rate of bone mineral density (BMD) decline at the lumbar spine

Rate of BMD decline =\[(BMD24-BMD Baseline)÷BMD baseline\]\*100%

Time frame: 24 months

Secondary Outcomes

Rate of fresh fractures, cardiovascular cerebrovascular adverse events and all-cause mortality

Fresh fractures were new non-traumatic fractures during follow-up. Cardiovascular cerebrovascular adverse events were Acute myocardial infarction, heart failure, shock, cardiac arrest, stroke, and lower limb arterial occlusion occurred during follow-up. All-cause mortality was death from any cause during follow-up.