TerminatedPhase 2

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

Stopped: Study lost funding

United States8 participantsStarted 2020-01-16

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Men and women
✓. All race-ethnicities
✓. Age ≥ 18 years
✓. ≥ 12-months after kidney transplantation (living or deceased donor recipient)
✓. Stable allograft function over the previous year defined as:
✓. No rejections
✓. No more than a 15% decline in Glomerular filtration rate (GFR) over the prior year
✓. Allograft GFR ≥ 30 mL/minute/1.73 m2 (MDRD or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) per local lab reporting)

Exclusion criteria

✕. Allograft GFR \< 30 mL/minute/1.73 m2 (MDRD or CKD-EPI per local lab reporting)
✕. Within 24-months of starting renal replacement therapy
✕

What they're measuring

Bone Mineral Density (BMD) Measured by Dual Energy X-ray Absorptiometry (DXA)

Timeframe: 12 months

Estimated Bone Strength Measured by High Resolution Peripheral Quantitative Computed Tomography (HR-pQCT) Imaging

Timeframe: 12 months

Trial details

NCT IDNCT03960554

SponsorThomas Nickolas, MD MS

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-02

Results submitted2024-07-01

View on ClinicalTrials.gov More Osteoporosis trials