Alendronate in Juvenile Osteoporosis

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Collaborators: FDA Office of Orphan Products Development; Merck Sharp & Dohme Corp.
• Treatments: Alendronate

Criteria

Inclusion Criteria:

• Participated in our earlier clinical study;

• Completed the earlier open label or double blind study;

• Availability to participate in the post study;

• Male and female children who have earlier participated in our clinical trial; AND

• Parental consent (and patient assent after age 12 years) to participate in the study. Participant's consent for those who have completed 18 years of age and above at the time of clinic visit.

Exclusion Criteria:

• Not participated in our earlier clinical study;

• Not completed our earlier trials; OR

• Pregnancy.