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| ID | Type | Description | Link |
|---|---|---|---|
| FD-R-001847-03 | Other Identifier | FDA | |
| 5R01FD001847-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| FDA Office of Orphan Products Development | FED |
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alendronate (Fosamax) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post study (1-6 yrs), one clinical visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post study (1-6 years), one clincial visit |
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Inclusion Criteria:
Exclusion Criteria:
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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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| Name | Affiliation | Role |
|---|---|---|
| Deborah A Bowlby, M.D. | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12795371 | Result | 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. |
| Label | URL |
|---|---|
| Juvenile Osteoporosis Clinical Trial | View source |
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Participants should have completed our earlier phase I or II study on alendronate in juvenile osteoporosis. Participants will be recruited by invitation only.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Last Study, 25 Pts Invited,11 Responded |
| |||||||||||||
| Post Study, 11 Pts Responded |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants who earlier completed our phase I or phase II study on alendronate in juvenile osteoporosis, were invited to participate in the current post study evaluation of bone density and fractures. | Posted | Number | participants | Post study (1-6 yrs), one clinical visit |
|
1-6 years post study
Participants who completed our earlier phase I/II study on alendronate in juvenile osteoporosis were invited to participate in the current post study evaluation of their current bone density/fracure history. Durine their one time clinic visit, they were asked regarding any adverse events they had during the period before coming to the post study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deborah A Bowlby, Asst.Professor, Pediatric Endocrinology | Medical University of South Carolina | 843-792-6807 | bowlbyd@musc.edu |
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| ID | Term |
|---|---|
| C537700 | Juvenile osteoporosis |
| D001851 | Bone Diseases, Metabolic |
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019386 | Alendronate |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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|
| 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. |
| Post study (1-6 years), one clinical visit |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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. | 11 participants responded to participate in the post study. Their bone density of Hip was measured by DXA scan. Increase in percentage density of Hip was obtained from that of previous values. One participant showed a slight decrease in bone density. | Posted | Number | participants | Post study (1-6 years), one clincial visit |
|
|
|
| Secondary | 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. | 11 participants responded to participate in the post study. During their one clinic visit, their fracture history during the period before coming to the post study was obtained. | Posted | Number | participants | Post study (1-6 years), one clinical visit |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
Agreement with Merck: to submit a copy of any proposed abstract, manuscript and/or press release to Merck for review and comment at least 30 days prior to submission for publication or presentation.
| D014947 | Wounds and Injuries |