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Antiepileptic Drugs and Osteoporotic Prevention Trial

NCT00869622 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2015-07-24

Study results available
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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.

Conditions

Interventions

DRUG

Risedronate

35 mgs/week + calcium and vit d

DRUG

Placebo + Calcium and Vitamin D

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

Sponsors & Collaborators

  • Procter and Gamble

    collaborator INDUSTRY

  • Alliance for Better Bone Health

    collaborator OTHER

  • VA Boston Healthcare System

    collaborator FED

  • Boston VA Research Institute, Inc.

    lead OTHER

Principal Investigators

  • Antonio A Lazzari, MD · VA Boston HCS

  • Phillip Dussault, Pharm D · VA Boston HCS

  • Manisha Thakore, MD · VA Boston HCS

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2012-10-31
Completion
2013-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00869622 on ClinicalTrials.gov