Antiepileptic Drugs and Osteoporotic Prevention Trial
Condition: Epilepsy; Bone Loss; Osteoporosis; Fractures
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Risedronate; Placebo + Calcium and Vitamin D
Intervention type(s): Drug; Drug
Intervention description(s): 35 mgs/week + calcium and vit d; sugar pill + calcium 1200mgs/day and vitamin d at least 800IU
Other intervention name(s): Actonel; Placebo
Intervention MeSH terms: Vitamin D; Risedronic Acid; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: osteoporosis; bone mineral density; fracture; antiepileptic drug; seizure; Prevention of bone loss; Prevention of osteoporosis; Prevention of Fractures