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Alendronate in Juvenile Osteoporosis

NCT00920075 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 11

Last updated 2018-07-11

Study results available
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Summary

The investigators earlier have shown that treatment of patients with juvenile osteoporosis with alendronate (Fosamax) for 12 months increased the bone density without side effects. In an open label study (10 patients) and double blind, crossover study (11 patients alendronate and 11 patients placebo), the investigators have further observed that alendronate increased the bone density significantly where as placebo (calcium and vitamin D) increased only minimally. These trials were completed. Thus, a post study is designed to evaluate the current status of the bone density and fractures after the patients discontinued the alendronate treatment. No treatment is involved.

Conditions

  • Juvenile Osteoporosis
  • Low Bone Density
  • Fractures

Interventions

DRUG

Alendronate (Fosamax)

Pill, 35mg or 70mg depending upon the body weight for 12 months. This was given for participants during the open label or double blind study. Current study is a post study evaluation of the current status of bone density after the participants completed the study. In this post study, no treatment is involved.

Sponsors & Collaborators

  • FDA Office of Orphan Products Development

    collaborator FED

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Deborah A Bowlby, M.D. · Medical University of South Carolina

Eligibility

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

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2009-09-30
Completion
2010-10-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00920075 on ClinicalTrials.gov