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Bone Mass and Strength After Kidney Transplantation

Primary Purpose

End Stage Renal Disease, Kidney Transplantation, Bone Loss

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vitamin D3
Calcitriol
Placebo
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for End Stage Renal Disease focused on measuring Kidney Transplantation, Calcitriol, Bone Mineral Density, Bone Mass and Strength, Vascular Calcifications, Hyperparathyroidism, Parathyroid Hormone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Columbia University Irving Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin D3 plus Calcitriol

Vitamin D3 plus Placebo

Arm Description

1 pill of Vitamin D3 (cholecalciferol) 1000 IU daily for 12 months 1 pill of Rocaltrol (calcitriol) 0.5 mcg daily for 12 months

1 pill of Vitamin D3 (cholecalciferol) 1000 IU per day for 12 months 1 pill of placebo (sugar pill) per day for 12 months

Outcomes

Primary Outcome Measures

Percent change in bone quality from pre to post-calcitriol treatment compared to placebo as assessed by both standard methodologies.
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

Change in Areal and Volumetric Bone Mass Density from baseline to 12 months after transplantation
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 cortical and trabecular bone strength pre- and post-transplantation measured by high resolution imaging methods.
Apply advanced imaging methods to determine the influence of calcitriol on cortical and trabecular microarchitecture and strength after kidney transplantation.
Percent contribution of cortical porosity to mechanical competence pre- and post-intervention measured by Cortical Porosity Assessment techniques.
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.
Changes from baseline to 12 months on vascular calcifications loads of the lower extremity
Measured by a novel method applied to HRpQCT datasets.
Number of patients with vascular calcifications of the lower extremity
Quantification of calcifications of the anterior and posterior tibia arteries measured by a novel method applied to HRpQCT at baseline and 12 months.
Change in pre- and post- intervention parathyroid hormone (PTH) levels at baseline,1 month and 12 months after transplantation.
Determine effects of calcitriol on post-transplantation PTH. .
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.
Determine effects of calcitriol on post-transplantation bone remodeling markers.

Full Information

First Posted
August 22, 2014
Last Updated
April 8, 2022
Sponsor
Columbia University
Collaborators
Satellite Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT02224144
Brief Title
Bone Mass and Strength After Kidney Transplantation
Official Title
A Comparative Trial of Calcitriol Versus Placebo for the Preservation of Bone Mass and Strength After Kidney Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 18, 2014 (Actual)
Primary Completion Date
October 12, 2016 (Actual)
Study Completion Date
October 12, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Satellite Healthcare

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Kidney Transplantation, Bone Loss, Fractures, Vascular Calcifications
Keywords
Kidney Transplantation, Calcitriol, Bone Mineral Density, Bone Mass and Strength, Vascular Calcifications, Hyperparathyroidism, Parathyroid Hormone

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D3 plus Calcitriol
Arm Type
Experimental
Arm Description
1 pill of Vitamin D3 (cholecalciferol) 1000 IU daily for 12 months 1 pill of Rocaltrol (calcitriol) 0.5 mcg daily for 12 months
Arm Title
Vitamin D3 plus Placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
cholecalciferol
Intervention Description
Vitamin D3 1000 IU per day for 12 months
Intervention Type
Drug
Intervention Name(s)
Calcitriol
Other Intervention Name(s)
Rocaltrol
Intervention Description
Calcitriol (Rocaltrol) 0.5 mcg per day for 12 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (sugar pill) 1 pill per day for 12 months
Primary Outcome Measure Information:
Title
Percent change in bone quality from pre to post-calcitriol treatment compared to placebo as assessed by both standard methodologies.
Description
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.
Time Frame
Baseline, 12 months
Secondary Outcome Measure Information:
Title
Change in Areal and Volumetric Bone Mass Density from baseline to 12 months after transplantation
Description
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.
Time Frame
Baseline, 12 months
Title
Percent change in cortical and trabecular bone strength pre- and post-transplantation measured by high resolution imaging methods.
Description
Apply advanced imaging methods to determine the influence of calcitriol on cortical and trabecular microarchitecture and strength after kidney transplantation.
Time Frame
Baseline, 12 months
Title
Percent contribution of cortical porosity to mechanical competence pre- and post-intervention measured by Cortical Porosity Assessment techniques.
Description
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.
Time Frame
Baseline, 12 months
Title
Changes from baseline to 12 months on vascular calcifications loads of the lower extremity
Description
Measured by a novel method applied to HRpQCT datasets.
Time Frame
Baseline, 12 months
Title
Number of patients with vascular calcifications of the lower extremity
Description
Quantification of calcifications of the anterior and posterior tibia arteries measured by a novel method applied to HRpQCT at baseline and 12 months.
Time Frame
Baseline, 12 months
Title
Change in pre- and post- intervention parathyroid hormone (PTH) levels at baseline,1 month and 12 months after transplantation.
Description
Determine effects of calcitriol on post-transplantation PTH. .
Time Frame
Baseline, 1month, 12 months
Title
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.
Description
Determine effects of calcitriol on post-transplantation bone remodeling markers.
Time Frame
Baseline, 1 month, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Nickolas, MD, MS
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24511131
Citation
Iyer SP, Nikkel LE, Nishiyama KK, Dworakowski E, Cremers S, Zhang C, McMahon DJ, Boutroy S, Liu XS, Ratner LE, Cohen DJ, Guo XE, Shane E, Nickolas TL. Kidney transplantation with early corticosteroid withdrawal: paradoxical effects at the central and peripheral skeleton. J Am Soc Nephrol. 2014 Jun;25(6):1331-41. doi: 10.1681/ASN.2013080851. Epub 2014 Feb 7.
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Bone Mass and Strength After Kidney Transplantation

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