Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bone Mass and Strength After Kidney Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02224144
Recruitment Status : Active, not recruiting
First Posted : August 25, 2014
Last Update Posted : January 30, 2019
Sponsor:
Collaborator:
Satellite Healthcare
Information provided by (Responsible Party):
Thomas Nickolas, MD MS, 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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Kidney Transplantation Bone Loss Fractures Vascular Calcifications Drug: Vitamin D3 Drug: Calcitriol Drug: Placebo Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Comparative Trial of Calcitriol Versus Placebo for the Preservation of Bone Mass and Strength After Kidney Transplantation
Actual Study Start Date : August 18, 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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

Drug: Vitamin D3
Vitamin D3 1000 IU per day for 12 months
Other Name: cholecalciferol

Drug: Calcitriol
Calcitriol (Rocaltrol) 0.5 mcg per day for 12 months
Other Name: Rocaltrol

Placebo Comparator: 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

Drug: Vitamin D3
Vitamin D3 1000 IU per day for 12 months
Other Name: cholecalciferol

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




Primary Outcome Measures :
  1. Percent change in bone quality 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 Outcome Measures :
  1. Change in Areal and Volumetric 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 cortical and trabecular bone strength pre- and post-transplantation measured by high resolution imaging methods. [ Time Frame: Baseline, 12 months ]
    Apply advanced imaging methods to determine the influence of calcitriol on cortical and trabecular microarchitecture and strength after kidney transplantation.

  3. Percent contribution of cortical porosity to mechanical competence pre- and post-intervention measured by Cortical Porosity Assessment techniques. [ Time Frame: Baseline, 12 months ]
    Apply Cortical Porosity Assessment techniques to high resolution peripheral quantitative computed tomography (HRpQCT) scans to quantify the contribution of cortical porosity to mechanical competence in kidney transplant patients both pre- and post-calcitriol treatment compared to placebo.

  4. Changes from baseline to 12 months on vascular calcifications loads of the lower extremity [ Time Frame: Baseline, 12 months ]
    Measured by a novel method applied to HRpQCT datasets.

  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. Change in pre- and post- intervention parathyroid hormone (PTH) levels at baseline,1 month and 12 months after transplantation. [ Time Frame: Baseline, 1month, 12 months ]

    Determine effects of calcitriol on post-transplantation PTH.

    .


  7. Change in pre- and post- intervention levels of bone remodeling markers for bone remodeling assessment from baseline to 1 month and 12 months after transplantation. [ Time Frame: Baseline, 1 month, 12 months ]
    Determine effects of calcitriol on post-transplantation bone remodeling markers.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02224144


Locations
Layout table for location information
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Satellite Healthcare
Investigators
Layout table for investigator information
Principal Investigator: Thomas Nickolas, MD, MS Columbia University

Publications:
Layout table for additonal information
Responsible Party: Thomas Nickolas, MD MS, Associate Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT02224144     History of Changes
Other Study ID Numbers: AAAM7850
First Posted: August 25, 2014    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Thomas Nickolas, MD MS, Columbia University:
Kidney Transplantation
Calcitriol
Bone Mineral Density
Bone Mass and Strength
Vascular Calcifications
Hyperparathyroidism
Parathyroid Hormone

Additional relevant MeSH terms:
Layout table for MeSH terms
Calcitriol
Kidney Failure, Chronic
Calcinosis
Vascular Calcification
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents