A Comparative Trial of Calcitriol Versus Placebo for the Preservation of Bone Mass and Strength After Kidney Transplantation
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Columbia University
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Percent Change in Bone Density From Pre to Post-calcitriol Treatment Compared to Placebo as Assessed by Both Standard Methodologies
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Vitamin D3 plus Calcitriol
1 pill of Vitamin D3 (cholecalciferol) 1000 IU daily for 12 months
1 pill of Rocaltrol (calcitriol) 0.5 mcg daily for 12 months
Intervention: Vitamin D3 (Drug)
Vitamin D3 plus Calcitriol
1 pill of Vitamin D3 (cholecalciferol) 1000 IU daily for 12 months
1 pill of Rocaltrol (calcitriol) 0.5 mcg daily for 12 months
Intervention: Calcitriol (Drug)
Vitamin D3 plus Placebo
1 pill of Vitamin D3 (cholecalciferol) 1000 IU per day for 12 months
1 pill of placebo (sugar pill) per day for 12 months
Intervention: Vitamin D3 (Drug)
Vitamin D3 plus Placebo
1 pill of Vitamin D3 (cholecalciferol) 1000 IU per day for 12 months
1 pill of placebo (sugar pill) per day for 12 months
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Percent Change in Bone Density From Pre to Post-calcitriol Treatment Compared to Placebo as Assessed by Both Standard Methodologies
Time Frame: Baseline, 12 months
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.
Secondary Outcomes
- Percent Change in Areal Bone Mass Density From Baseline to 12 Months After Transplantation(Baseline, 12 months)
- Percent Change in Failure Load Pre- and Post-transplantation Measured by High Resolution Imaging Methods(Baseline, 12 months)
- Percent Change of Cortical Porosity Pre- and Post-intervention(Baseline, 12 months)
- Percent Change in Vascular Calcifications Loads of the Lower Extremity(Baseline, 12 months)
- Number of Patients With Vascular Calcifications of the Lower Extremity(Baseline, 12 months)
- Percent Change in Pre- and Post- Intervention Parathyroid Hormone (PTH) Levels(Baseline, 12 months)
- Percent Change in Pre- and Post- Intervention Levels of Bone Remodeling Markers for Bone Remodeling Assessment(Baseline, 12 months)