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The Effects of 12-months of Denosumab on Bone Density in Prevalent Kidney Transplant Recipients

NCT03960554 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-07-25

Study results available
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Summary

This is a Phase 2 Multi-Center Clinical Trial (safety and effectiveness trial) in 60 patients (40 denosumab; 20 placebo) who have had a kidney transplant for 12-months or longer with more than 30% of kidney function. The investigators will test whether denosumab safely improves bone mineral density (BMD) by dual-energy X-ray absorptiometry (DXA) and improves bone strength by high resolution peripheral quantitative computed tomography (HR-pQCT) in the subset of patients recruited at Columbia University Irving Medical Center. These data will inform the development and execution of a larger trial to test if denosumab prevents fractures in kidney transplant recipients.

Conditions

  • Osteoporosis
  • Renal Osteodystrophy
  • Kidney Transplant; Complications

Interventions

DRUG

Denosumab Inj 60 mg/ml

Treatment will be administered by study personnel as a subcutaneous injection every 6-months for one year.

OTHER

Placebo

Placebo will be administered by study personnel as a subcutaneous injection every 6-months for one year.

Sponsors & Collaborators

  • Thomas Nickolas, MD MS

    lead OTHER

Principal Investigators

  • Thomas Nickolas, MD, MS · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-16
Primary Completion
2021-12-02
Completion
2021-12-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03960554 on ClinicalTrials.gov