Bone Mass and Strength After Kidney Transplantation

Phase 2

Completed

• Conditions: End Stage Renal Disease; Fractures; Kidney Transplantation; Bone Loss; Vascular Calcifications
• Interventions: Drug: Vitamin D3; Drug: Placebo; Drug: Calcitriol

• Registration Number: NCT02224144
• Lead Sponsor: Columbia University

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 Timeline

• Study Start: 2014-08-18
• Study First Submitted: 2014-08-22
• Study First Submitted QC: 2014-08-22
• Study First Posted: 2014-08-25
• Primary Completion: 2016-10-12
• Study Completion: 2016-10-12
• Results First Submitted: 2025-02-10
• Status Verified: 2025-03
• Results First Submitted QC: 2025-03-04
• Last Update Submitted: 2025-03-04
• Results First Posted: 2025-03-07
• Last Update Posted: 2025-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D3 plus Placebo	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
Vitamin D3 plus Calcitriol	Vitamin D3	1 pill of Vitamin D3 (cholecalciferol) 1000 IU daily for 12 months 1 pill of Rocaltrol (calcitriol) 0.5 mcg daily for 12 months
Vitamin D3 plus Calcitriol	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
Vitamin D3 plus Placebo	Vitamin D3	1 pill of Vitamin D3 (cholecalciferol) 1000 IU per day for 12 months 1 pill of placebo (sugar pill) per day for 12 months

Primary Outcome Measures

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

Name	Time	Method
Percent Change in Areal Bone Mass Density From Baseline to 12 Months After Transplantation	Baseline, 12 months	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.
Percent Change in Failure Load Pre- and Post-transplantation Measured by High Resolution Imaging Methods	Baseline, 12 months	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.
Percent Change of Cortical Porosity Pre- and Post-intervention	Baseline, 12 months	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.
Percent Change in Vascular Calcifications Loads of the Lower Extremity	Baseline, 12 months	A semi-automated algorithm implemented in image processing language was used for assessment of lower leg arterial calcification (LLAC) and wrist arterial calcification (WAC).
Number of Patients With Vascular Calcifications of the Lower Extremity	Baseline, 12 months	Quantification of calcifications of the anterior and posterior tibia arteries measured by a novel method applied to HRpQCT at baseline and 12 months.
Percent Change in Pre- and Post- Intervention Parathyroid Hormone (PTH) Levels	Baseline, 12 months	PTH levels were measured in participants to confirm the hypothesis that calcitriol administration over the first year of kidney transplantation would protect the cortical skeleton in recipients managed without corticosteroids due to its ability to suppress PTH and bone remodeling.
Percent Change in Pre- and Post- Intervention Levels of Bone Remodeling Markers for Bone Remodeling Assessment	Baseline, 12 months	Participants underwent a blood draw for measurement of bone markers: bone-specific alkaline phosphatase (BSAP), propeptide of type 1 procollagen (P1NP), osteocalcin (OC), and the bone resorption marker serum cross-linked C-telopeptide of type I collagen (CTX).

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States