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Alendronate Osteoporosis Study

NCT00277251 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-04-11

No results posted yet for this study

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.

Conditions

  • Glucocorticoid-Associated Osteopenia and Osteoporosis

Interventions

DRUG

Alendronate

Sponsors & Collaborators

  • Glaser Pediatric Research Network

    collaborator NETWORK

  • Elizabeth Glaser Pediatric AIDS Foundation

    collaborator OTHER

  • Boston Children's Hospital

    lead OTHER

Principal Investigators

  • Catherine Gordon, MD · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
8 Years
Max Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-03-31
Primary Completion
2006-06-30
Completion
2006-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00277251 on ClinicalTrials.gov