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NCT00869622 · ClinicalTrials.gov registry record · Phase 4
Antiepileptic Drugs and Osteoporotic Prevention Trial
A Phase 4 study, sponsored by Boston VA Research Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 80
- Enrollment target
NCT00869622: Completed Phase 4 study, sponsored by Boston VA Research Institute.
NCT00869622 is a Phase 4 study that has completed, run by Boston VA Research Institute. The registered enrollment target is 80 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00869622, a Phase 4 study, has completed, sponsored by Boston VA Research Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 80 participants
- Enrollment target
Study Summary
Study Design: (e.g., Controlled, Double-Blind, Randomized, Parallel): Randomized, double-blind, placebo controlled of a bisphosphonate in the prevention of bone loss associated with the use of antiepileptic drugs.
Primary Outcome
Patients with a T-Score of \> -2.5 were randomized into two possible arms. A bisphosphonate group received 35mg risedronate weekly while another group received an identical placebo tablet weekly. Both groups received supplemental calcium and vitamin D. Enrolled patients had bone density measurements of bilateral proximal femur, A-P lumbar spine, total body, forearm and L-P spine. All measurements were performed on a GE Lunar Bone Densitometer (iDXA) instrument. Measurements of 25-hydroxy vitami
Interventions
- DRUG Risedronate
- DRUG Placebo + Calcium and Vitamin D
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2006-06 |
| Est. Completion | 2013-01 |
| Phase | Phase 4 |
What the finished NCT00869622 record still lists
NCT00869622 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Risedronate is the first listed.
NCT00869622 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00869622 about?
NCT00869622 is a clinical study titled "Antiepileptic Drugs and Osteoporotic Prevention Trial". Study Design: (e.g., Controlled, Double-Blind, Randomized, Parallel): Randomized, double-blind, placebo controlled of a bisphosphonate in the prevention of bone loss associated with the use of antiepileptic drugs.
What is the current status of trial NCT00869622?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 80 participants. The study started on 2006-06. Estimated completion is 2013-01.
What interventions are being tested in trial NCT00869622?
The interventions under investigation include: Risedronate (DRUG), Placebo + Calcium and Vitamin D (DRUG).
Who is sponsoring clinical trial NCT00869622?
This trial is sponsored by Boston VA Research Institute, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00869622's enrollment target sits among peer trials
80 946th of 2000 higher than 1,021 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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