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Completed

NCT Number: NCT02224144

Bone Mass and Strength After Kidney Transplantation

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.

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Key information

Conditions

End Stage Renal Disease Bone Diseases Bone Diseases, Metabolic Bone Loss Calcinosis Calcium Metabolism Disorders Chronic Disease Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fractures Fractures, Bone Hyperparathyroidism Kidney Diseases Kidney Failure, Chronic Kidney Transplantation Male Urogenital Diseases Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Parathyroid Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Calcification Vascular Calcifications Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3

Drug

Vitamin D3 1000 IU per day for 12 months

Other names: cholecalciferol

calcitriol

Drug

Calcitriol (Rocaltrol) 0.5 mcg per day for 12 months

Other names: Rocaltrol

Placebo

Drug

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

Primary outcomes

  1. 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

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

    Time frame: 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.

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

    Time frame: 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.

  3. Percent Change of Cortical Porosity Pre- and Post-intervention

    Time frame: 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.

  4. Percent Change in Vascular Calcifications Loads of the Lower Extremity

    Time frame: 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).

  5. Number of Patients With Vascular Calcifications of the Lower Extremity

    Time frame: 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.

  6. Percent Change in Pre- and Post- Intervention Parathyroid Hormone (PTH) Levels

    Time frame: 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.

  7. Percent Change in Pre- and Post- Intervention Levels of Bone Remodeling Markers for Bone Remodeling Assessment

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Satellite Healthcare

Registry information

Official study title

A Comparative Trial of Calcitriol Versus Placebo for the Preservation of Bone Mass and Strength After Kidney Transplantation

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 25, 2014
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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