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.
Full Title of Study: “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.”
- Study Type: Observational
- Study Design
- Time Perspective: Other
- Study Primary Completion Date: September 2009
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.
- 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.
Arms, Groups and Cohorts
- 1 Alendronate for 12 months, post study
- Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
Clinical Trial Outcome Measures
- Bone Mineral Density (BMD) of the Lumbar Spine (Participants With Percentage Increase).
- Time Frame: Post study (1-6 yrs), one clinical visit
- Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Bone density of spine was measured by DXA scan.
- Bone Mineral Density (BMD) of the Hip (Participants With Percentage Increase).
- Time Frame: Post study (1-6 years), one clincial visit
- Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Bone density of hip was measured by DXA scan.
- Number of Participants With Fracture
- Time Frame: Post study (1-6 years), one clinical visit
- Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Their bone densities of spine and hip were measured by DXA scan. During this visit, their fracture history was obtained.
Participating in This Clinical Trial
- 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.
Gender Eligibility: All
Minimum Age: 8 Years
Maximum Age: 21 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Medical University of South Carolina
- FDA Office of Orphan Products Development
- Provider of Information About this Clinical Study
- Deborah A Bowlby, MD, Assistant Professor, Medical University of South Carolina
- Overall Official(s)
- Deborah A Bowlby, M.D., Principal Investigator, Medical University of South Carolina
Citations Reporting on Results
Key LL Jr, Ries W, Madyastha P, Reed F. Juvenile osteoporosis: recognizing the risk. J Pediatr Endocrinol Metab. 2003 May;16 Suppl 3:683-6.
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