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Trial record 76 of 101 for:    Risedronate

Antiepileptic Drugs and Osteoporotic Prevention Trial (ADOPT)

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ClinicalTrials.gov Identifier: NCT00869622
Recruitment Status : Completed
First Posted : March 26, 2009
Results First Posted : July 24, 2015
Last Update Posted : July 24, 2015
Sponsor:
Collaborators:
Procter and Gamble
Alliance for Better Bone Health
VA Boston Healthcare System
Information provided by (Responsible Party):
Antonio Lazzari, Boston VA Research Institute, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Epilepsy
Bone Loss
Osteoporosis
Fractures
Interventions Drug: Risedronate
Drug: Placebo + Calcium and Vitamin D
Enrollment 80
Recruitment Details 80 veterans with epilepsy who were treated with phenobarbital, phenytoin, carbamazepine and sodium valproate.
Pre-assignment Details 80 epileptic patients who have been on phenytoin, phenobarbital, carbamazepine or sodium divalproex for at least 2 years were enrolled.
Arm/Group Title Risedronate Placebo Sugar Pill
Hide Arm/Group Description

Active drug

Risedronate: 35 mgs/week + calcium and vit d

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

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

Period Title: Overall Study
Started 40 40
Completed 27 26
Not Completed 13 14
Arm/Group Title Risedronate Placebo Sugar Pill Total
Hide Arm/Group Description Active drug participants received calcium and vitamin D supplementation in addition to 35 mgs of risedronate tablet weekly Placebo participants received calcium and vitamin D supplementation in addition to a placebo tablet identical to risedronate tablet weekly Total of all reporting groups
Overall Number of Baseline Participants 40 40 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
  52.5%
29
  72.5%
50
  62.5%
>=65 years
19
  47.5%
11
  27.5%
30
  37.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 80 participants
63  (13) 58  (13) 61  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
40
 100.0%
40
 100.0%
80
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants 40 participants 80 participants
40 40 80
Type of seizures  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Grand Mal Seizures 19 22 41
Other types of seizures 21 18 39
Current Smokers  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Smokers 29 28 57
Non Smokers 11 12 23
Baseline Vitamin D Level  
Mean (Standard Deviation)
Unit of measure:  Ng/ml
Number Analyzed 40 participants 40 participants 80 participants
29.1  (19) 29.3  (16) 29.2  (17.5)
Previous Vertebral Fractures  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Previous vertebral fractures 15 9 24
No veterbral fractures 25 31 56
1.Primary Outcome
Title Changes in Bone Mineral Density
Hide Description

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.

Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The study design involved 80 veterans with epilepsy who were treated with phenobarbital, phenytoin, carbamazepine and sodium valproate. This is a prospective study in which 80 patients who have been on phenytoin, phenobarbital, carbamazepine or sodium divalproex for at least 2 years were enrolled.
Arm/Group Title Risedronate Placebo Sugar Pill
Hide Arm/Group Description:

Active drug

Risedronate: 35 mgs/week + calcium and vit d

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

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

Overall Number of Participants Analyzed 27 26
Mean (Standard Deviation)
Unit of Measure: g/cm2
Bilateral Proximal Femora 1.025  (0.111) 0.999  (0.174)
L1-L4 AP Spine 1.332  (0.111) 1.245  (0.154)
Total Body BMD 1.205  (0.096) 1.192  (0.127)
2.Secondary Outcome
Title Vertebral Fractures
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Risedronate Placebo + Calcium and Vitamin D
Hide Arm/Group Description:

Active drug

Risedronate: 35 mgs/week + calcium and vit d

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

Placebo + Calcium and Vitamin D: sugar pill + calcium 1200mgs/day and vitamin d at least 800IU

Overall Number of Participants Analyzed 27 26
Measure Type: Number
Unit of Measure: Vertebral Fractures
0 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Risedronate, Placebo + Calcium and Vitamin D
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0229
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Risedronate Placebo Sugar Pill
Hide Arm/Group Description

Active drug

Risedronate: 35 mgs/week + calcium and vit d

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

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

All-Cause Mortality
Risedronate Placebo Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Risedronate Placebo Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Risedronate Placebo Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Antonio A. Lazzari, M.D., Ph.D
Organization: VA Boston Healthcare System
Phone: (857) 364-6381
Responsible Party: Antonio Lazzari, Boston VA Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT00869622     History of Changes
Other Study ID Numbers: VABHS IRB#1889
First Submitted: March 25, 2009
First Posted: March 26, 2009
Results First Submitted: January 28, 2015
Results First Posted: July 24, 2015
Last Update Posted: July 24, 2015