Clinical trial NCT02224144: Bone Mass and Strength After Kidney Transplantation
Official title: A Comparative Trial of Calcitriol Versus Placebo for the Preservation of Bone Mass and Strength After Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: End Stage Renal Disease
Kidney Transplantation
Bone Loss
Fractures
Vascular Calcifications
Keywords: Kidney Transplantation
Calcitriol
Bone Mineral Density
Bone Mass and Strength
Vascular Calcifications
Hyperparathyroidism
Parathyroid Hormone
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Satellite Healthcare
First posted: 2014-08-25
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 in the regulation of the absorption of calcium from the gastrointestinal tract and its utilization in the body.

Eligibility criteria: 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

Primary outcomes:
measure: Percent Change in Bone Density From Pre to Post-calcitriol Treatment Compared to Placebo as Assessed by Both Standard Methodologies
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: Percent Change in Areal Bone Mass Density From Baseline to 12 Months After Transplantation
timeFrame: Baseline, 12 months
measure: Percent Change in Failure Load Pre- and Post-transplantation Measured by High Resolution Imaging Methods
timeFrame: Baseline, 12 months
measure: Percent Change of Cortical Porosity Pre- and Post-intervention
timeFrame: Baseline, 12 months
measure: Percent Change in Vascular Calcifications Loads of the Lower Extremity
timeFrame: Baseline, 12 months
measure: Number of Patients With Vascular Calcifications of the Lower Extremity
timeFrame: Baseline, 12 months
measure: Percent Change in Pre- and Post- Intervention Parathyroid Hormone (PTH) Levels
timeFrame: Baseline, 12 months
measure: Percent Change in Pre- and Post- Intervention Levels of Bone Remodeling Markers for Bone Remodeling Assessment
timeFrame: Baseline, 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Thomas Nickolas, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Iyer SP, Nikkel LE, Nishiyama KK, Dworakowski E, Cremers S, Zhang C, McMahon DJ, Boutroy S, Liu XS, Ratner LE, Cohen DJ, Guo XE, Shane E, Nickolas TL. Kidney transplantation with early corticosteroid withdrawal: paradoxical effects at the central and peripheral skeleton. J Am Soc Nephrol. 2014 Jun;25(6):1331-41. doi: 10.1681/ASN.2013080851. Epub 2014 Feb 7.