Status:
COMPLETED
Alendronate in Juvenile Osteoporosis
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
FDA Office of Orphan Products Development
Merck Sharp & Dohme LLC
Conditions:
Juvenile Osteoporosis
Low Bone Density
Eligibility:
All Genders
8-21 years
Brief 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 st...
Detailed Description
With the availability of Dual Energy X-ray Absorptiometry (DXA), juvenile osteoporosis has been recognized and diagnosed in recent years. The disease results from either diminished bone formation or i...
Eligibility Criteria
Inclusion
- 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
- Not participated in our earlier clinical study;
- Not completed our earlier trials; OR
- Pregnancy.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00920075
Start Date
July 1 2009
End Date
October 1 2010
Last Update
July 11 2018
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425