NCT00920075

Alendronate in Juvenile Osteoporosis

Phase II Study of Alendronate Sodium in Juvenile Osteoporosis (IND# 60,017)-Post Study Evaluation of Participants From Phase IIa and Phase IIb Clinical Study.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 11 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 8 Years – 21 Years
• Healthy volunteers: Not accepted

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.

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 increased bone removal (resorption) resulting in low bone density and fractures. No specific drug therapy has been recommended for juvenile osteoporosis. In an open label study, we earlier have shown that alendronate treatment (10 patients) for 12 months increased bone density without side effects. Subsequently, in a double blind, crossover study, we have further confirmed that alendronate treatment (11 patients) increased bone density significantly whereas, placebo (11 patients with calcium and vitamin D), increased the bone density only minimally. There were no side effects. These patients were treated with alendronate only for 12 months and the clinical trials have been completed. We therefore, have designed a post study to evaluate the current status of the bone density and fracture history in the above participants after the discontinuation (1-6 years) of alendronate treatment. Available participants, who have completed the earlier study, will be scheduled for a one time clinic visit. Measurements include DXA bone density measurement of spine and hip, urinalysis and blood work. No treatment is involved.

Conditions

• Juvenile Osteoporosis
• Low Bone Density
• Fractures

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-07-01
• Primary completion: 2009-09-01
• Completion: 2010-10-01
• First posted: 2009-06-15
• Last updated: 2018-07-11
• Results posted: 2010-12-10

Locations

1 site across 1 country: United States