Phase 4 Completed N=80 Randomized Quadruple-blind Prevention

Antiepileptic Drugs and Osteoporotic Prevention Trial

Epilepsy · Bone loss · Osteoporosis · Fracture

Source: ClinicalTrials.gov NCT00869622 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2015

Primary outcomePrimary: Changes in Bone Mineral Density — 1.025; 0.999; 1.332; 1.245 g/cm2

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Changes in Bone Mineral Density	1.025; 0.999; 1.332; 1.245; 1.205; 1.192	—
SECONDARY Vertebral Fractures	0; 5	0.0229 sig

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00869622). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.