An observational study in Juvenile Osteoporosis, Low Bone Density and Fractures, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 8 Years to 21 Years. Per ClinicalTrials.gov, last updated 2018-07-11.
Sponsored by Medical University of South Carolina · Observational
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.
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.
487 studies on the registry are indexed under Bone Diseases, Metabolic; 74 are open to participants now.
This study's enrollment of 11 is below the median of 80 across 107 observational studies indexed under Bone Diseases, Metabolic.
Browse Bone Diseases, Metabolic studies →Medical University of South Carolina is the lead sponsor of 871 studies on the registry; 163 are open to participants now.
Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.
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Available male and female children who have participated and Completed in our earlier open label or double blind clinical trial.
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Exclusion Criteria:
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.
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.
Also known as: Fosamax
Bone Mineral Density (BMD) of the Lumbar Spine (Participants With Percentage Increase).
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.
Time frame: Post study (1-6 yrs), one clinical visit
Bone Mineral Density (BMD) of the Hip (Participants With Percentage Increase).
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.
Time frame: Post study (1-6 years), one clincial visit
Number of Participants With Fracture
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.
Time frame: Post study (1-6 years), one clinical visit
Participants who have completed our earlier phase-1 and II study on alendronate in juvenile osteoporosis will be invited in this post study to evaluate the bone density/ fractures after discontinuation of therapy. Interested participants will be scheduled for a one time clinic visit. No treatment is involved.
| Milestone | 1 Alendronate for 12 Months, Post Study |
|---|---|
| Started | 11 |
| Completed | 11 |
| Not completed | 0 |
| Milestone | 1 Alendronate for 12 Months, Post Study |
|---|---|
| Started | 11 |
| Completed | 11 |
| Not completed | 0 |
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.
| participants | 1 Alendronate for 12 Months, Post Study |
|---|---|
| Bone Mineral Density (BMD) of the Lumbar Spine (Participants With Percentage Increase). | 11 |
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.
| participants | 1 Alendronate for 12 Months, Post Study |
|---|---|
| Bone Mineral Density (BMD) of the Hip (Participants With Percentage Increase). | 10 |
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.
| participants | 1 Alendronate for 12 Months, Post Study |
|---|---|
| Number of Participants With Fracture | 0 |
Collected over 1-6 years post study. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 1 Alendronate for 12 Months, Post Study | — | 0/11 (0%) | 0/11 (0%) |
| Age, Categorical(Participants) | 1 Alendronate for 12 Months, Post Study |
|---|---|
| <=18 years | 11 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(years) | 1 Alendronate for 12 Months, Post Study |
|---|---|
| Mean | 12.9 ± 2.7 |
| Sex: Female, Male(Participants) | 1 Alendronate for 12 Months, Post Study |
|---|---|
| Female | 6 |
| Male | 5 |
| Region of Enrollment(participants) | 1 Alendronate for 12 Months, Post Study |
|---|---|
| United States | 11 |
This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.
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