NCT02224144

Bone Mass and Strength After Kidney Transplantation

A Comparative Trial of Calcitriol Versus Placebo for the Preservation of Bone Mass and Strength After Kidney Transplantation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test whether active vitamin D (calcitriol) protects bones from weakening and protects blood vessels from calcium deposits over the first year of kidney transplantation.

Detailed description

Kidney transplant recipients at highest fracture risk, as determined by epidemiologic studies (Caucasians and older recipients). Rocaltrol (calcitriol) is a synthetic vitamin D analog which is active in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body.

Conditions

• End Stage Renal Disease
• Kidney Transplantation
• Bone Loss
• Fractures
• Vascular Calcifications

Interventions

Type	Name	Description
DRUG	Vitamin D3	Vitamin D3 1000 IU per day for 12 months
DRUG	Calcitriol	Calcitriol (Rocaltrol) 0.5 mcg per day for 12 months
DRUG	Placebo	Placebo (sugar pill) 1 pill per day for 12 months

Timeline

• Start date: 2014-08-18
• Primary completion: 2016-10-12
• Completion: 2016-10-12
• First posted: 2014-08-25
• Last updated: 2025-03-07
• Results posted: 2025-03-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study