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Antiepileptic Drugs and Osteoporotic Prevention Trial (ADOPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00869622
Recruitment Status : Completed
First Posted : March 26, 2009
Results First Posted : July 24, 2015
Last Update Posted : July 24, 2015
Procter and Gamble
Alliance for Better Bone Health
VA Boston Healthcare System
Information provided by (Responsible Party):
Antonio Lazzari, Boston VA Research Institute, Inc.

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.

Condition or disease Intervention/treatment Phase
Epilepsy Bone Loss Osteoporosis Fractures Drug: Risedronate Drug: Placebo + Calcium and Vitamin D Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Antiepileptic Drugs and Osteoporotic Prevention Trial
Study Start Date : June 2006
Actual Primary Completion Date : October 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Vitamin D

Arm Intervention/treatment
Active Comparator: Risedronate
Active drug
Drug: Risedronate
35 mgs/week + calcium and vit d
Other Name: Actonel

Placebo Comparator: Placebo + Calcium and Vitamin D
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
Other Name: Placebo

Primary Outcome Measures :
  1. Changes in Bone Mineral Density [ Time Frame: 2 years ]

    Patients with a T-Score of > -2.5 were randomized into two possible arms. A bisphosphonate group received 35mg risedronate weekly while another group received an identical placebo tablet weekly. Both groups received supplemental calcium and vitamin D.

    Enrolled patients had bone density measurements of bilateral proximal femur, A-P lumbar spine, total body, forearm and L-P spine. All measurements were performed on a GE Lunar Bone Densitometer (iDXA) instrument. Measurements of 25-hydroxy vitamin D, NTX , serum calcium and blood chemistries occurred at scheduled intervals.

Secondary Outcome Measures :
  1. Vertebral Fractures [ Time Frame: 2 years ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00869622

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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
VA Boston Healthcare System
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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
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Responsible Party: Antonio Lazzari, Director Osteoporosis Prevention and Treatment Center VABHCS, Boston VA Research Institute, Inc. Identifier: NCT00869622    
Other Study ID Numbers: VABHS IRB#1889
First Posted: March 26, 2009    Key Record Dates
Results First Posted: July 24, 2015
Last Update Posted: July 24, 2015
Last Verified: July 2015
Keywords provided by Antonio Lazzari, Boston VA Research Institute, Inc.:
bone mineral density
antiepileptic drug
Prevention of bone loss
Prevention of osteoporosis
Prevention of Fractures
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Vitamin D
Risedronic Acid
Growth Substances
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action