Bone Mass and Strength After Kidney Transplantation

Description

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.

Study Start Date

August 2014

Estimated Completion Date

December 2018

Interventions

  • Drug: Vitamin D3 plus Calcitriol
  • Drug: Vitamin D3 plus Placebo

Specialties

  • Urology: Kidney,Oncology
  • Nephrology: Transplantation

MeSH Terms

  • Calcinosis
  • End Stage Renal Disease
  • Vascular Calcification

Study ID

Columbia University -- AAAM7850

Status

Unknown

Trial ID

NCT02224144

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

100

Sponsor

Columbia University

Inclusion Criteria

  • Age older than 40
  • Caucasian race

Exclusion Criteria

  • Lower extremity amputations
  • non-ambulatory
  • Malignancy requiring chemotherapy or metastatic to bone
  • PagetĀ“s
  • Current hyperthyroidism, untreated hypothyroidism
  • Medical diseases (end stage liver, intestinal malabsorption)
  • More than 1 year of biphosphonates
  • any use of teriparatide
  • 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
  • Diagnosis of peripheral vascular disease
  • MI or stroke
  • Tobacco use within the past year

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Columbia University Medical Center - New York City, New York 44.8 miles Thomas Nickolas MD MS 212-305-3273 tln2001@cumc.columbia.edu

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