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Antiepileptic Drugs and Osteoporotic Prevention Trial (ADOPT)

This study has been completed.
Sponsor:
Collaborators:
Procter and Gamble
Alliance for Better Bone Health
Information provided by (Responsible Party):
Antonio Lazzari, VA Boston Healthcare System
ClinicalTrials.gov Identifier:
NCT00869622
First received: March 25, 2009
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Epilepsy
Bone Loss
Osteoporosis
Fractures
Drug: Risedronate
Drug: Placebo + calcium and vitamin d
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Boston VA Research Institute, Inc.:

Primary Outcome Measures:
  • Changes in bone mineral density [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fractures [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: June 2006
Study Completion Date: January 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Risedronate
Active drug
Drug: Risedronate
35 mgs/week + calcium and vit d
Placebo Comparator: Placebo sugar pill
All patients both on placebo and active bisphosphonate to receive calcium and vitamin D
Drug: Placebo + calcium and vitamin d
sugar pill + calcium 1200mgs/day and vitamin d at least 800IU

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869622

Locations
United States, Massachusetts
VA Boston Healthcare System
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
Boston VA Research Institute, Inc.
Procter and Gamble
Alliance for Better Bone Health
Investigators
Principal Investigator: Antonio A Lazzari, MD VA Boston HCS
Principal Investigator: Phillip Dussault, Pharm D VA Boston HCS
Principal Investigator: Manisha Thakore, MD VA Boston HCS
  More Information

No publications provided

Responsible Party: Antonio Lazzari, Director Osteoporosis Prevention and Treatment Center VABHCS, VA Boston Healthcare System
ClinicalTrials.gov Identifier: NCT00869622     History of Changes
Other Study ID Numbers: VABHS IRB#1889
Study First Received: March 25, 2009
Last Updated: July 15, 2014
Health Authority: United States: Federal Government

Keywords provided by Boston VA Research Institute, Inc.:
osteoporosis
bone mineral density
fracture
antiepileptic drug
seizure
Prevention of bone loss
Prevention of osteoporosis
Prevention of Fractures

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Anticonvulsants
Ergocalciferols
Risedronic acid
Vitamin D
Vitamins
Bone Density Conservation Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Growth Substances
Membrane Transport Modulators
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014