Alendronate versus calcitriol for the prevention of bone loss after cardiac transplantation

N Engl J Med. 2004 Feb 19;350(8):767-76. doi: 10.1056/NEJMoa035617.

Abstract

Background: Osteoporosis is a well-known complication of cardiac transplantation. We conducted a randomized trial comparing alendronate with calcitriol for the prevention of bone loss during the first year after cardiac transplantation.

Methods: A total of 149 patients were randomly assigned to receive either alendronate (10 mg per day) or calcitriol (0.5 microg per day) a mean (+/-SD) of 21+/-11 days after transplantation. Estimates of bone loss and the incidence of fractures among untreated patients were obtained from a reference group of 27 prospectively recruited patients who received cardiac transplants within the same period as the intervention groups.

Results: At one year, the bone mineral density at the lumbar spine had decreased by a mean of 0.7 percent in the alendronate group and 1.6 percent in the calcitriol group (P=0.25 for the test of no difference). The bone mineral density at the femoral neck decreased by a mean of 1.7 percent in the alendronate group and 2.1 percent in the calcitriol group (P=0.69). In the reference group, the mean bone mineral density at the lumbar spine decreased by 3.2 percent (P=0.03 for the comparison with the alendronate group; P=0.15 for the comparison with the calcitriol group), and the mean density at the femoral neck decreased by 6.2 percent (P=0.001 for comparisons with both intervention groups). The incidence of vertebral fractures did not differ significantly among the groups (6.8 percent in the alendronate group, 3.6 percent in the calcitriol group, and 13.6 percent in the reference group). Hypercalciuria developed in 27 percent of the patients in the calcitriol group and 7 percent of those in the alendronate group (P=0.01).

Conclusions: The degree of bone loss and the rates of fracture did not differ significantly between the intervention groups. Calcitriol was associated with a higher risk of hypercalciuria. Alendronate-treated patients sustained less bone loss at the spine than those in the reference group, and both intervention groups sustained less bone loss at the hip than the reference group. The requirement for monitoring the serum and urinary calcium levels in calcitriol-treated patients makes alendronate more attractive for the prevention of bone loss early after cardiac transplantation.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Alendronate / adverse effects
  • Alendronate / pharmacology
  • Alendronate / therapeutic use*
  • Bone Density / drug effects
  • Bone Resorption / prevention & control*
  • Calcitriol / adverse effects
  • Calcitriol / pharmacology
  • Calcitriol / therapeutic use*
  • Calcium / blood
  • Calcium / urine
  • Collagen / blood
  • Collagen Type I
  • Female
  • Fractures, Bone / prevention & control
  • Heart Transplantation*
  • Humans
  • Immunosuppression
  • Male
  • Middle Aged
  • Parathyroid Hormone / blood
  • Peptides / blood
  • Postoperative Complications / prevention & control*

Substances

  • Collagen Type I
  • Parathyroid Hormone
  • Peptides
  • collagen type I trimeric cross-linked peptide
  • Collagen
  • Calcitriol
  • Calcium
  • Alendronate