Osteoporosis Prevention After Heart Transplant
Condition: Osteoporosis; Cardiac Transplantation
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      During the first year after a heart transplant, people often rapidly lose bone from their
      spine and hips. About 35 percent of people who receive heart transplants will suffer broken
      bones during the first year after transplantation. This study will compare the safety and
      effectiveness of the drug alendronate (Fosamax) and the active form of vitamin D (calcitriol)
      in preventing bone loss at the spine and hip after a heart transplant.

      In this study, people who have had a successful heart transplant will receive either active
      alendronate and a "dummy pill" instead of calcitriol, or active calcitriol and a dummy pill
      instead of alendronate for the first year after their transplant, starting within 1 month
      after transplant surgery. We will measure bone density in the hip and spine at the start of
      the study and after 6 and 12 months, and will also check for broken bones in the spine. This
      research should lead to ways of preventing this crippling form of osteoporosis.
    

Detailed description: 
      We will enroll patients who have undergone cardiac transplantation into a randomized,
      double-blind, 12-month study of the efficacy and safety of calcitriol (Rocaltrol) and
      alendronate sodium (Fosamax) in the prevention of bone loss after transplantation. We will
      give all participants standard pre- and post-transplantation management and immunosuppressive
      therapy, three tablets of calcium citrate (Citracal + D, each containing 315 mg of elemental
      calcium and 200 IU of vitamin D), and a multivitamin providing 400 units of vitamin D daily.
      We will randomize participants to one of two active treatment groups within 1 month of
      transplantation. We will give Group A active alendronate (10 mg/day) and placebo calcitriol.
      We will give Group B placebo alendronate and active calcitriol (0.25 micrograms BID). The
      primary efficacy endpoint is the change in spine bone mineral density (BMD) during the first
      6 months after transplantation. The secondary efficacy endpoint is the change in hip BMD
      during the first year after transplantation. We will also monitor the incidence of vertebral
      fracture.

      We will invite eligible subjects to participate in the study. We will offer patients who
      elect not to participate in the therapeutic trial the opportunity to have serial BMD
      measurements at the same intervals as treated subjects and to be followed as untreated
      controls. We will continue recruitment until we have randomized a total of 146 cardiac
      transplant recipients. We will perform bone densitometry at randomization (unless performed
      within the previous month) and at 6 and 12 months. We will obtain radiographs (x-rays) at
      randomization and will repeat them at 12 months to detect undiagnosed vertebral fractures.
    

Intervention name(s): Alendronate; Calcitriol; Placebo Alendronate; Placebo Calcitriol
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Alendronate; Calcitriol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Osteoporosis; Osteopenia; Heart transplant; Bone fracture; Bone density; Dual energy x-ray absorptiometry