Conditions: Renal Insufficiency
Keywords: bone density osteopenia transplant zoledronic acid alendronate
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 59
Healthy volunteers: no

Brief summary:
The study is designed to look at the effect of different bone treatment plans on bone loss after kidney or kidney/pancreas transplant.

Detailed description:
The aims are to determine baseline bone mineral density (BMD) in kidney and kidney/pancreas transplant patients who will be randomized to weekly alendronate, annual zoledronic acid infusions or placebo (calcium with Vitamin D). These patients will be followed for two years with annual bone density testing as well as biochemical markers. A secondary aim is to evaluate the compliance.

Arms:
arm 1: Zoledronic Acid 4mg intravenously once a year for 2 years arm 2: Alendronate 70mg orally once a week for 2 years arm 3: Combination drug entity: calcium 1200 mg with vitamin D 800 International Units daily

Interventions: intervention 1: Zoledronic Acid intervention 2: Calcium with vitamin D intervention 3: Alendronate
Intervention descriptions: intervention 1: 4mg IV Annually intervention 2: 1200 mg Calcium with 800 International Units of vitamin D intervention 3: 70mg weekly

Protocol document: