CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 80 enrolled
Drug / intervention
Risedronate +1 moredrug
Likely dose
Placebo + Calcium and Vitamin D 800IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00869622
NCT00869622Phase 4Completed
CompareCT.gov

Antiepileptic Drugs and Osteoporotic Prevention Trial

Boston VA Research Institute, Inc.·interventional·Posted Mar 26, 2009·Updated Jul 24, 2015

In Brief

A Phase 4 clinical trial evaluating Risedronate and Placebo + Calcium and Vitamin D for Epilepsy and 3 related conditions. Completed, enrolled 80 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy, Bone Loss, Osteoporosis, Fractures
CountriesUnited States
CollaboratorsProcter and Gamble, Alliance for Better Bone Health, VA Boston Healthcare System

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 26, 2009
Enrollment StartJun 1, 2006
Primary CompletionOct 1, 2012
Study CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 17.3 years ago

Interventions

Risedronatedrug

35 mgs/week + calcium and vit d

Placebo + Calcium and Vitamin Ddrug

sugar pill + calcium 1200mgs/day and vitamin d at least 800IU