Status:
COMPLETED
Bone Mass and Strength After Kidney Transplantation
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Satellite Healthcare
Conditions:
End Stage Renal Disease
Kidney Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- Age older than 18
- Self-describes as White race
Exclusion
- Lower extremity amputations
- Non-ambulatory
- Paget´s disease of bone
- Current hyperthyroidism, untreated hypothyroidism
- Medical diseases (end stage liver, intestinal malabsorption)
- Use within the prior year pod anti-seizure medications that induce the cytochrome P450 system, testosterone, estrogen, selective estrogen receptor modulators
- Weight \>300 pounds
- Dual organ transplant
- Myocardial infarction or stroke
- Tobacco use within the past year
Key Trial Info
Start Date :
August 18 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2016
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT02224144
Start Date
August 18 2014
End Date
October 12 2016
Last Update
March 7 2025
Active Locations (1)
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1
Columbia University Irving Medical Center
New York, New York, United States, 10032