Antiepileptic Drugs and Osteoporotic Prevention Trial

Completed · Phase 4 · Has a placebo group

Conditions studied: Epilepsy, Bone Loss, Osteoporosis, Fractures

In brief

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.

Key facts

Study ID

NCT00869622

Run by

Boston VA Research Institute, Inc.

People needed

80

Starts

2006-06-01

Expected to finish

2013-01-01

Last updated by the study team

2015-07-24

Who can join

Age: 18 and older, up to 85. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male gender
• Epilepsy
• Anti-epileptic drug treatment with phenytoin, or phenobarbital or valproate sodium
• Normal renal function and normal Vitamin D and calcium levels

You may not qualify if…

• 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

Where it is running

• VA Boston Healthcare System — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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