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NCT00259857 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Alendronate (Fosamax) in Children With Osteoporosis
A Phase 2 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT00259857: Completed Phase 2 study, sponsored by Medical University of South Carolina.
NCT00259857 is a Phase 2 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00259857, a Phase 2 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study Summary
We have previously evaluated the safety and efficacy of Alendronate in 10 patients with juvenile osteoporosis during a 12-month clinical trial. We have documented that Alendronate improved BMD of the spine and hip without any major side effects. There were no additional fractures during therapy. The present study is designed to further evaluate the safety and efficacy of Alendronate in 20 children with juvenile osteoporosis using a double-blind, randomized, placebo-controlled, cross-over protocol.
Primary Outcome
Participants were screened for BMD of lumbar spine using DXA scan at visit 12 months after alendronate or placebo treatment.
Interventions
- DRUG Alendronate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2003-10 |
| Est. Completion | 2009-08 |
| Phase | Phase 2 |
What the finished NCT00259857 record still lists
NCT00259857 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which Alendronate is the first listed.
NCT00259857 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00259857 about?
NCT00259857 is a clinical study titled "Safety and Efficacy of Alendronate (Fosamax) in Children With Osteoporosis". We have previously evaluated the safety and efficacy of Alendronate in 10 patients with juvenile osteoporosis during a 12-month clinical trial. We have documented that Alendronate improved BMD of the spine and hip without any major side effects. There were no additional fractures during therapy. The...
What is the current status of trial NCT00259857?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2003-10. Estimated completion is 2009-08.
What interventions are being tested in trial NCT00259857?
The interventions under investigation include: Alendronate (DRUG).
Who is sponsoring clinical trial NCT00259857?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00259857's enrollment target sits among peer trials
22 1790th of 2000 higher than 207 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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