Antiepileptic Drugs and Osteoporotic Prevention Trial

NCT ID: NCT00869622

Last Updated: 2015-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2013-01-31

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 antiepileptic drugs.

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, you will have a bone mineral density test (BMD) of your hip and spine. A BMD is similar to having an x-ray and is a test that measures the amount of bone. This test takes approximately 15 minutes. Radiation exposure during this test is very low. It has been estimated that the total radiation exposure from a bone mineral density measurement is lower than that of a dental x-ray. At each follow up visit an assessment will be made for side effects and whether or not you followed the prescribed treatment.

Initially, information collected will include height, weight, seizure history and seizure medication history, other medical conditions, bone and muscle symptoms you currently have, dietary calcium intake, and exercise. Blood will be drawn at the initial and 5 follow-up visits. The purpose of this is to test your blood for organ function, calcium levels, vitamin D levels and levels of markers that show high bone turnover. Also at each visit your height and weight will be checked and you will be asked questions regarding side effects, adherence to treatment and quality of life.

When you agree to participate, you will be randomized to either risedronate 35mg tablet (Actonel ®) or placebo (a fake pill) to take once a week. Randomization is a process in which you will have an equal chance (like the flip of a coin) to be assigned to either risedronate (Actonel ®) or placebo. A computer program will determine your treatment assignment. Also during the study you will be provided with calcium and vitamin D tablets to take either two or three times each day depending on your dietary calcium intake.

At the first visit you will be assessed for changeable risk factors for osteoporosis. These include smoking, alcohol consumption, and lack of physical activity, poor nutrition and lack of vitamin intake. Also, blood will be drawn to see if you have a low male hormone. If you are found to have low male hormone, you will be referred to your primary care provider. If you have low male hormone levels, you will be eligible to participate in the study if testosterone replacement has been offered to you and you have declined treatment. If you decide to be treated with testosterone you are not eligible to participate in this study. Education will be provided on exercises for bones. If you smoke, you will be counseled on quitting although quitting is not a requirement to participate in the study. If you drink a lot of alcohol you will be counseled on reducing your intake and offered help. Reducing or quitting alcohol is not a requirement for your participation in this study. You can also meet with a registered dietician for nutritional counseling.

Conditions

Epilepsy; Bone Loss; Osteoporosis; Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Risedronate

Active drug

Group Type: ACTIVE_COMPARATOR

Risedronate

Intervention Type: DRUG

35 mgs/week + calcium and vit d

Placebo + Calcium and Vitamin D

All patients both on placebo and active bisphosphonate to receive calcium and vitamin D

Group Type: PLACEBO_COMPARATOR

Placebo + Calcium and Vitamin D

Intervention Type: DRUG

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

Interventions

Risedronate

35 mgs/week + calcium and vit d

Intervention Type: DRUG

Placebo + Calcium and Vitamin D

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

Intervention Type: DRUG

Other Intervention Names

Actonel; Placebo

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Procter and Gamble

INDUSTRY

Sponsor Role: collaborator

Alliance for Better Bone Health

OTHER

Sponsor Role: collaborator

VA Boston Healthcare System

FED

Sponsor Role: collaborator

Boston VA Research Institute, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Antonio Lazzari

Director Osteoporosis Prevention and Treatment Center VABHCS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio A Lazzari, MD

Role: PRINCIPAL_INVESTIGATOR

VA Boston HCS

Phillip Dussault, Pharm D

Role: PRINCIPAL_INVESTIGATOR

VA Boston HCS

Manisha Thakore, MD

Role: PRINCIPAL_INVESTIGATOR

VA Boston HCS

Locations

VA Boston Healthcare System

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

VABHS IRB#1889

Identifier Type: -

Identifier Source: org_study_id