A randomized controlled trial of calcium with vitamin D, alone or in combination with intravenous pamidronate, for the treatment of low bone mineral density associated with Crohn's disease

Aliment Pharmacol Ther. 2003 Dec;18(11-12):1121-7. doi: 10.1111/j.1365-2036.2003.01794.x.

Abstract

Background: Osteoporosis is a common complication of Crohn's disease.

Aim: To study the effect on the bone mineral density of a bisphosphonate (pamidronate) given intravenously, in combination with oral calcium and vitamin D supplements, compared with oral calcium and vitamin D supplements alone.

Methods: Seventy-four patients with Crohn's disease and low bone mineral density at the lumbar spine and/or hip were randomized to receive either a daily dose of 500 mg of calcium with 400 IU of vitamin D alone or in combination with four three-monthly infusions of 30 mg of intravenous pamidronate over the course of 12 months. The main outcome measure was the change in bone mineral density at the lumbar spine and hip, measured by dual X-ray absorptiometry, at baseline and 12 months.

Results: Both groups gained bone mineral density at the lumbar spine and hip after 12 months. There were significant (P < 0.05) changes in the pamidronate group, with gains of + 2.6%[95% confidence interval (CI), 1.4-3.0] at the spine and + 1.6% (95% CI, 0.6-2.5) at the hip, compared with gains of + 1.6% (95% CI, - 0.1-3.2) and + 0.9% (95% CI, - 0.4-2.1) at the spine and hip, respectively, in the group taking vitamin D and calcium supplements alone.

Conclusions: In patients with Crohn's disease and low bone mineral density, intravenous pamidronate significantly increases the bone mineral density at the lumbar spine and hip.

Publication types

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

MeSH terms

  • Administration, Oral
  • Anti-Inflammatory Agents / administration & dosage*
  • Bone Demineralization, Pathologic / drug therapy*
  • Bone Demineralization, Pathologic / etiology
  • Bone Demineralization, Pathologic / physiopathology
  • Bone Demineralization, Pathologic / urine
  • Bone Density
  • Calcium / administration & dosage*
  • Collagen / urine
  • Collagen Type I
  • Crohn Disease / complications*
  • Crohn Disease / physiopathology
  • Crohn Disease / urine
  • Diphosphonates / administration & dosage*
  • Double-Blind Method
  • Drug Therapy, Combination
  • Humans
  • Infusions, Intravenous
  • Pamidronate
  • Peptides / urine
  • Treatment Outcome
  • Vitamin D / administration & dosage*

Substances

  • Anti-Inflammatory Agents
  • Collagen Type I
  • Diphosphonates
  • Peptides
  • collagen type I trimeric cross-linked peptide
  • Vitamin D
  • Collagen
  • Pamidronate
  • Calcium