Phase 2 N=61 Randomized Quadruple-blind Prevention

Bone Mass and Strength After Kidney Transplantation

End Stage Renal Disease · Kidney Transplantation · Bone Loss · Fractures · Vascular Calcifications

Bottom Line

View on ClinicalTrials.gov: NCT02224144 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2025

Primary outcome: Primary: Percent Change in Bone Density From Pre to Post-calcitriol Treatment Compared to Placebo as Assessed by Both Standard Methodologies — -0.81; -0.70 percent change

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Vitamin D3 (Drug); Calcitriol (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Columbia University
Primary completion: Oct 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change in Bone Density From Pre to Post-calcitriol Treatment Compared to Placebo as Assessed by Both Standard Methodologies	-0.81; -0.70	—
SECONDARY Percent Change in Areal Bone Mass Density From Baseline to 12 Months After Transplantation	1.91; 0.85; 0.88; -0.09; 0.64; -0.45	—
SECONDARY Percent Change in Failure Load Pre- and Post-transplantation Measured by High Resolution Imaging Methods	-5; -3.4; -1.9; -2.5	—
SECONDARY Percent Change of Cortical Porosity Pre- and Post-intervention	11.6; 12.5; 21; 13.3	—
SECONDARY Percent Change in Vascular Calcifications Loads of the Lower Extremity	1.5; -8.4; 112; 68	—
SECONDARY Number of Patients With Vascular Calcifications of the Lower Extremity	13; 9; 13; 8	—
SECONDARY Percent Change in Pre- and Post- Intervention Parathyroid Hormone (PTH) Levels	-63; -59	—
SECONDARY Percent Change in Pre- and Post- Intervention Levels of Bone Remodeling Markers for Bone Remodeling Assessment	9.6; 60; -80; -72; -14; 2.9	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02224144). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.