Trial Outcomes & Findings for Antiepileptic Drugs and Osteoporotic Prevention Trial (NCT NCT00869622)

Last Updated: 2015-07-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

80 participants

Primary outcome timeframe

2 years

Results posted on

2015-07-24

Participant Flow

80 veterans with epilepsy who were treated with phenobarbital, phenytoin, carbamazepine and sodium valproate.

80 epileptic patients who have been on phenytoin, phenobarbital, carbamazepine or sodium divalproex for at least 2 years were enrolled.

Participant milestones

Participant milestones
Measure	Risedronate Active drug Risedronate: 35 mgs/week + calcium and vit d	Placebo Sugar Pill 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 Study STARTED	40	40
Overall Study COMPLETED	27	26
Overall Study NOT COMPLETED	13	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Antiepileptic Drugs and Osteoporotic Prevention Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Risedronate n=40 Participants Active drug participants received calcium and vitamin D supplementation in addition to 35 mgs of risedronate tablet weekly	Placebo Sugar Pill n=40 Participants Placebo participants received calcium and vitamin D supplementation in addition to a placebo tablet identical to risedronate tablet weekly	Total n=80 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	29 Participants n=7 Participants	50 Participants n=5 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants	11 Participants n=7 Participants	30 Participants n=5 Participants
Age, Continuous	63 years STANDARD_DEVIATION 13 • n=5 Participants	58 years STANDARD_DEVIATION 13 • n=7 Participants	61 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants	40 participants n=7 Participants	80 participants n=5 Participants
Type of seizures Grand Mal Seizures	19 participants n=5 Participants	22 participants n=7 Participants	41 participants n=5 Participants
Type of seizures Other types of seizures	21 participants n=5 Participants	18 participants n=7 Participants	39 participants n=5 Participants
Current Smokers Smokers	29 participants n=5 Participants	28 participants n=7 Participants	57 participants n=5 Participants
Current Smokers Non Smokers	11 participants n=5 Participants	12 participants n=7 Participants	23 participants n=5 Participants
Baseline Vitamin D Level	29.1 ng/ml STANDARD_DEVIATION 19 • n=5 Participants	29.3 ng/ml STANDARD_DEVIATION 16 • n=7 Participants	29.2 ng/ml STANDARD_DEVIATION 17.5 • n=5 Participants
Previous Vertebral Fractures Previous vertebral fractures	15 participants n=5 Participants	9 participants n=7 Participants	24 participants n=5 Participants
Previous Vertebral Fractures No veterbral fractures	25 participants n=5 Participants	31 participants n=7 Participants	56 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Population: 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.

Outcome measures

Outcome measures
Measure	Risedronate n=27 Participants Active drug Risedronate: 35 mgs/week + calcium and vit d	Placebo Sugar Pill n=26 Participants 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
Changes in Bone Mineral Density Bilateral Proximal Femora	1.025 g/cm2 Standard Deviation 0.111	0.999 g/cm2 Standard Deviation 0.174
Changes in Bone Mineral Density L1-L4 AP Spine	1.332 g/cm2 Standard Deviation 0.111	1.245 g/cm2 Standard Deviation 0.154
Changes in Bone Mineral Density Total Body BMD	1.205 g/cm2 Standard Deviation 0.096	1.192 g/cm2 Standard Deviation 0.127

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Risedronate n=27 Participants Active drug Risedronate: 35 mgs/week + calcium and vit d	Placebo Sugar Pill n=26 Participants 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
Vertebral Fractures	0 Vertebral Fractures	5 Vertebral Fractures

Adverse Events

Risedronate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Sugar Pill

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Antonio A. Lazzari, M.D., Ph.D

VA Boston Healthcare System

Phone: (857) 364-6381

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place