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NCT00022841 · ClinicalTrials.gov registry record · Phase 1
Prevention of Steroid-Induced Osteoporosis in Children
A Phase 1 study, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- Terminated
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT00022841 is a Phase 1 study that was terminated before completion, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The registered enrollment target is 40 participants.
The verdict
NCT00022841, a Phase 1 study, was terminated before completion, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether the drug pamidronate can safely and effectively improve bone mineral density in growing children who have bone disease caused by taking steroid medications. People who take steroid medications called glucocorticoids, like prednisone or dexamethasone, for long periods almost always have decreased bone density and are at increased risk of breaking a bone. Research has shown that pamidronate improves bone density in adults who take glucocorticoids. However, use of pamidronate is not approved in children because it has not been extensively tested in children. It is possible that children will have a different response or unique problems with the medication because their bones are still growing. We will assign all study participants to one of two groups. One group will receive pamidronate intravenously (through a vein) every 3 months in addition of daily oral calcium and vitamin D and the other group will receive calcium and vitamin D. The study is scheduled to run for 36 months, with visits to the study center once every 3 months.
Interventions
- DRUG Pamidronate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Est. Completion | 2005-09 |
| Phase | Phase 1 |
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)93 total trials
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00022841
The ClinicalTrials.gov registry entry for NCT00022841 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Pamidronate is the first listed.
NCT00022841 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00022841 about?
NCT00022841 is a clinical study titled "Prevention of Steroid-Induced Osteoporosis in Children". The purpose of this study is to determine whether the drug pamidronate can safely and effectively improve bone mineral density in growing children who have bone disease caused by taking steroid medications. People who take steroid medications called glucocorticoids, like prednisone or dexamethasone,...
What is the current status of trial NCT00022841?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 40 participants. Estimated completion is 2005-09.
What interventions are being tested in trial NCT00022841?
The interventions under investigation include: Pamidronate (DRUG).
Who is sponsoring clinical trial NCT00022841?
This trial is sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total clinical trials registered on ClinicalTrials.gov.
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