Bone Mass and Strength After Kidney Transplantation

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02224144
• Other study ID #: AAAM7850
• Status: Completed
• Phase: Phase 2
• Start date: August 18, 2014
• Est. completion date: October 12, 2016

Study information

• Verified date: April 2022
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: October 12, 2016
• Est. primary completion date: October 12, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Loss
• Calcinosis
• End Stage Renal Disease
• Fractures
• Kidney Failure, Chronic
• Kidney Transplantation
• Vascular Calcification
• Vascular Calcifications

Intervention

Drug:
• Vitamin D3
Vitamin D3 1000 IU per day for 12 months
• Calcitriol
Calcitriol (Rocaltrol) 0.5 mcg per day for 12 months
• Placebo
Placebo (sugar pill) 1 pill per day for 12 months

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Satellite Healthcare

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 12 months
Secondary	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.	Baseline, 12 months
Secondary	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.	Baseline, 12 months
Secondary	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.	Baseline, 12 months
Secondary	Changes from baseline to 12 months on vascular calcifications loads of the lower extremity	Measured by a novel method applied to HRpQCT datasets.	Baseline, 12 months
Secondary	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.	Baseline, 12 months
Secondary	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.; .	Baseline, 1month, 12 months
Secondary	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.	Baseline, 1 month, 12 months