Clinical Trial: Alendronate Osteoporosis Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Double-Blinded Controlled Trial of Alendronate for the Treatment of Childhood and Adolescent Glucocorticoid- Associated Osteopenia and Osteoporosis

Brief Summary: This trial will test the hypothesis that among 20 children and adolescents from Children's Hospital, Boston with Crohn's disease, ulcerative colitis, systemic-onset juvenile rheumatoid arthritis, juvenile dermatomyositis, systemic lupus erythematosus, mixed connective tissue disease and vasculitis, treatment of glucocorticoid-associated osteopenia and osteoporosis with 18 months of alendronate (FOSAMAX®, Merck & Co., Inc.) will result in greater improvement in the mean change of individual AP spine bone mineral density (BMD) (gm/cm2) determined by dual energy X-ray absorptiometry (DXA) than treatment with 18 months of standard of care therapy.

Detailed Summary:
Sponsor: Boston Children’s Hospital

Current Primary Outcome: To test the hypothesis that among children and adolescents with Crohn's disease, ulcerative colitis, systemic-onset juvenile rheumatoid arthritis, juvenile dermatomyositis, systemic lupus erythematosus, mixed connective tissue disease and vasculitis, tr

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Alternate outcome measures
  • Comparison of DXA and QCT
  • Predictors for response to alendronate
  • Growth velocity
  • Fracture assessment


Original Secondary Outcome: Same as current

Information By: Boston Children’s Hospital

Dates:
Date Received: July 7, 2005
Date Started: March 2003
Date Completion:
Last Updated: April 10, 2017
Last Verified: April 2017