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Denosumab Treatment in CKD Patients at High Risk of Fracture

Primary Purpose

Chronic Kidney Diseases, Fracture, Bone Density, Low

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Denosumab
Non-denosumab
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Denosumab, Chronic Kidney Diseases, Treatment, Fracture

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nephrology Department of Beijing Jishuitan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Denosumab group

Non-denosumab group

Arm Description

Fifty-one patients were randomly assigned to the denosumab group, which received subcutaneous injection of denosumab 60mg once every 6 months. Serum calcium, phosphorus, alkaline phosphatase, iPTH, tPINP, 25(OH)VitD, DXA and qCT were measured before medication. Serum calcium, phosphorus and iPTH were examined at day 1, 7 and 14, alkaline phosphatase, tPINP and 25(OH)VitD at day 7 and 14, and electrocardiogram at day 1 and 7 after treatment. Intravenous calcium supplementation was required if muscle spasms and QT prolongation occurred. Six months after medication, subcutaneous injections of denosumab 60mg were repeated. The protocol was repeated every 6 months, totally 24 months. Bone mineral density, clinical parameters and adverse events were evaluated at 24 months.

The other 51 patients did not use denosumab and used other medications, such as diphosphonates, active vitamin D and/or active vitamin D analogue, calcimimetics, calcitonin, estrogen receptor agonists, etc. At the same time, calcium and vitamin D were supplemented. The baseline serum calcium, phosphorus, alkaline phosphatase, iPTH, tPINP, 25(OH)VitD, DXA, and qCT were measured. The above parameters were rechecked every 6 months, and the medications was recorded, totally 24 months.

Outcomes

Primary Outcome Measures

Rate of bone mineral density (BMD) decline at the lumbar spine
Rate of BMD decline =[(BMD24-BMD Baseline)÷BMD baseline]*100%

Secondary Outcome Measures

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.

Full Information

First Posted
January 11, 2023
Last Updated
January 20, 2023
Sponsor
Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05692297
Brief Title
Denosumab Treatment in CKD Patients at High Risk of Fracture
Official Title
Denosumab Treatment in Patients With Chronic Kidney Disease (CKD) at High Risk of Fracture: A Prospective, Randomised Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Fracture, Bone Density, Low, End Stage Renal Disease
Keywords
Denosumab, Chronic Kidney Diseases, Treatment, Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Denosumab group
Arm Type
Experimental
Arm Description
Fifty-one patients were randomly assigned to the denosumab group, which received subcutaneous injection of denosumab 60mg once every 6 months. Serum calcium, phosphorus, alkaline phosphatase, iPTH, tPINP, 25(OH)VitD, DXA and qCT were measured before medication. Serum calcium, phosphorus and iPTH were examined at day 1, 7 and 14, alkaline phosphatase, tPINP and 25(OH)VitD at day 7 and 14, and electrocardiogram at day 1 and 7 after treatment. Intravenous calcium supplementation was required if muscle spasms and QT prolongation occurred. Six months after medication, subcutaneous injections of denosumab 60mg were repeated. The protocol was repeated every 6 months, totally 24 months. Bone mineral density, clinical parameters and adverse events were evaluated at 24 months.
Arm Title
Non-denosumab group
Arm Type
Active Comparator
Arm Description
The other 51 patients did not use denosumab and used other medications, such as diphosphonates, active vitamin D and/or active vitamin D analogue, calcimimetics, calcitonin, estrogen receptor agonists, etc. At the same time, calcium and vitamin D were supplemented. The baseline serum calcium, phosphorus, alkaline phosphatase, iPTH, tPINP, 25(OH)VitD, DXA, and qCT were measured. The above parameters were rechecked every 6 months, and the medications was recorded, totally 24 months.
Intervention Type
Drug
Intervention Name(s)
Denosumab
Intervention Description
The patients in the denosumab group received subcutaneous injection of denosumab 60mg once every 6 months for 24 months.
Intervention Type
Drug
Intervention Name(s)
Non-denosumab
Intervention Description
Taken other medications, such as diphosphonates, active vitamin D and/or active vitamin D analogue, calcimimetics, calcitonin, estrogen receptor agonists, etc.
Primary Outcome Measure Information:
Title
Rate of bone mineral density (BMD) decline at the lumbar spine
Description
Rate of BMD decline =[(BMD24-BMD Baseline)÷BMD baseline]*100%
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Rate of fresh fractures, cardiovascular cerebrovascular adverse events and all-cause mortality
Description
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.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dongliang Zhang, Director
Phone
+861058396938
Email
zdlycy@163.com
Facility Information:
Facility Name
Nephrology Department of Beijing Jishuitan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100035
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongliang Zhang, Director
Phone
+860150963534
Email
zhangdongliang@jst-hosp.com.cn

12. IPD Sharing Statement

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Denosumab Treatment in CKD Patients at High Risk of Fracture

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