Antiepileptic Drugs and Osteoporotic Prevention Trial

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston VA Research Institute, Inc.
• Collaborators: Alliance for Better Bone Health; Procter and Gamble; VA Boston Healthcare System
• Treatments: Anticonvulsants; Calcium; Calcium, Dietary; Ergocalciferols; Risedronate Sodium; Risedronic Acid; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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