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 23, 2013
Last verified: July 2013
  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

  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
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 23, 2013
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:
Epilepsy
Fractures, Bone
Osteoporosis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Anticonvulsants
Risedronic acid
Vitamin D
Ergocalciferols
Vitamins
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Bone Density Conservation Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 21, 2014