NCT02224144.

Trial name or title	Bone mass and strength after kidney transplantation
Methods	Country: USA Study design: double‐blind, parallel RCT Duration of follow‐up: 12 months
Participants	Inclusion criteria: kidney transplant recipients over 18 years old and self‐describes as of white race/ethnicity 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, oestrogen, selective oestrogen receptor modulators; weight > 300 pounds; dual organ transplant; myocardial infarction or stroke; tobacco smoking the past year
Interventions	Treatment group Calcitriol (oral): 0.5 µg/d for 12 months Control group Placebo Co‐interventions Vitamin D3 (oral): 1000 IU/d
Outcomes	Percent changes in bone quality from pre to post‐calcitriol treatment compared to placebo as assessed by both standard (DXA, PTH, and bone turnover markers and novel (HRpQCT, Finite Element Analysis) methodologies Changes in areal and volumetric bone mass density from baseline to 12 months after transplantation measured by DXA and HRpQCT Percent changes in cortical and trabecular bone strength pre and post transplantation measured by high resolution imaging methods Percent contribution of cortical porosity to mechanical competence pre‐ and post‐intervention measured by Cortical Porosity Assessment techniques Changes from baseline to 12 months on vascular calcifications loads of the lower extremity by a novel method applied to HRpQCT data sets Number of patients with vascular calcifications of the lower extremity measured by a novel method applied to HRpQCT at baseline and 12 months Changes in pre‐ and post‐ intervention PTH levels at baseline,1 month and 12 months after transplantation Changes in pre‐ and post‐ intervention levels of bone remodelling markers for bone remodelling assessment from baseline to 1 month and 12 months after transplantation
Starting date	August 2014
Contact information	Thomas Nickolas: tln2001@cumc.columbia.edu Daniel Velez: dav2125@cumc.columbia.edu
Notes	Study currently recruiting patients