Bone Mass and Strength After Kidney Transplantation

Columbia University

Status and phase: Completed; Phase 2

Conditions: Vascular Calcifications; Kidney Transplantation; Fractures; End Stage Renal Disease; Bone Loss

Treatments: Drug: Placebo; Drug: Calcitriol; Drug: Vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT02224144

AAAM7850

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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61 participants in 2 patient groups, including a placebo group

Vitamin D3 plus Calcitriol

Experimental group

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

Treatment:

Drug: Vitamin D3

Drug: Calcitriol

Vitamin D3 plus Placebo

Placebo Comparator group

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

Treatment:

Drug: Vitamin D3

Drug: Placebo