Bone Mass and Strength After Kidney Transplantation

April 8, 2022 updated by: Thomas Nickolas, MD MS, Columbia University

A Comparative Trial of Calcitriol Versus Placebo for the Preservation of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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 Names:
  • cholecalciferol
Drug: Calcitriol
Calcitriol (Rocaltrol) 0.5 mcg per day for 12 months
Other Names:
  • 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 Names:
  • cholecalciferol
Drug: Placebo
Placebo (sugar pill) 1 pill per day for 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 12 months
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.
Baseline, 12 months
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.
Baseline, 12 months
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.
Baseline, 12 months
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.
Baseline, 12 months
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.

.
Baseline, 1month, 12 months
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.
Baseline, 1 month, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

Satellite Healthcare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 18, 2014

Primary Completion (ACTUAL)

October 12, 2016

Study Completion (ACTUAL)

October 12, 2016

Study Registration Dates

First Submitted

August 22, 2014

First Submitted That Met QC Criteria

August 22, 2014

First Posted (ESTIMATE)

August 25, 2014

Study Record Updates

Last Update Posted (ACTUAL)

April 15, 2022

Last Update Submitted That Met QC Criteria

April 8, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAM7850

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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