Bone Mass and Strength After Kidney Transplantation

Columbia University61 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

End Stage Renal Disease Kidney Transplantation Bone Loss Fractures Vascular Calcifications

Interventions

Vitamin D3DRUG

Vitamin D3 1000 IU per day for 12 months

CalcitriolDRUG

Calcitriol (Rocaltrol) 0.5 mcg per day for 12 months

PlaceboDRUG

Placebo (sugar pill) 1 pill per day for 12 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age older than 18 * Self-describes as White race Exclusion Criteria: * 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

Locations (1)

Columbia University Irving Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

Percent Change in Bone Density From Pre to Post-calcitriol Treatment Compared to Placebo as Assessed by Both Standard Methodologies

Novel high resolution bone imaging can separately measure and quantify cortical and trabecular responses to bone active treatments. Finite element analysis (FEA) can be applied to HRpQCT datasets. to provide a computational estimate of bone mechanical competence that has been validated against true compressive tests of bone stiffness and strength.

Time frame: Baseline, 12 months

Secondary Outcomes

Percent Change in Areal Bone Mass Density From Baseline to 12 Months After Transplantation

Apply imaging methods to shed light on whether preservation of areal bone mineral density (BMD) measured by dual-energy x-ray absorptiometry (DXA) is accompanied by preservation of bone mechanical competence measured by a method that has been validated against true compressive tests of bone strength.

Time frame: Baseline, 12 months

Percent Change in Failure Load Pre- and Post-transplantation Measured by High Resolution Imaging Methods

Failure load refers to the maximum amount of force a bone can withstand before it fractures. Volumetric BMD and microarchitecture of cortical and trabecular compartments were measured using HR-pQCT first- (XCT1) and second-generation scanners (XCT2), with voxel size 82 μm and 60 μm respectively. HR-pQCT imaging was performed on the non-dominant radius and tibia.

Time frame: Baseline, 12 months

Percent Change of Cortical Porosity Pre- and Post-intervention

Cortical porosity was calculated as the percentage of void space in the cortex. HR-pQCT imaging was performed on the non-dominant radius and tibia.

Time frame: Baseline, 12 months

Percent Change in Vascular Calcifications Loads of the Lower Extremity

A semi-automated algorithm implemented in image processing language was used for assessment of lower leg arterial calcification (LLAC) and wrist arterial calcification (WAC).

Data from ClinicalTrials.gov

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