Status:
COMPLETED
Antiepileptic Drugs and Osteoporotic Prevention Trial
Lead Sponsor:
Boston VA Research Institute, Inc.
Collaborating Sponsors:
Procter and Gamble
Alliance for Better Bone Health
Conditions:
Epilepsy
Bone Loss
Eligibility:
MALE
18-85 years
Phase:
PHASE4
Brief 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 antiep...
Detailed Description
The study is planned to last two years. You will be required to make a total of 6 visits to the clinic during this two year study period. At the first visit, 12 months and, approximately 24 months, yo...
Eligibility Criteria
Inclusion
- Male gender
- Epilepsy
- Anti-epileptic drug treatment with phenytoin, or phenobarbital or valproate sodium
- Normal renal function and normal Vitamin D and calcium levels
Exclusion
- Female gender
- Organ transplant
- Use of oral glucocorticoids
- Renal insufficiency (eGFR \< 30ml/min)
- Severe swallowing disorder
- Severe esophagitis
- Patients taking sodium valproate for reasons other than epilepsy
- Previous treatment with osteoporosis drugs such as bisphosphonates, calcitonin or PTH analog
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00869622
Start Date
June 1 2006
End Date
January 1 2013
Last Update
July 24 2015
Active Locations (1)
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1
VA Boston Healthcare System
Boston, Massachusetts, United States, 02130