EpilepsyPhase 4ADOPTNCT00869622
Antiepileptic Drugs and Osteoporotic Prevention Trial
A Phase 4 study testing Risedronate in people with Epilepsy and Bone Loss, run by Boston VA Research Institute, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Epilepsy, Bone Loss, Osteoporosis
- What is being tested?
- Risedronate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Jan 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male gender
- Epilepsy
- Anti-epileptic drug treatment with phenytoin, or phenobarbital or valproate sodium
- Normal renal function and normal Vitamin D and calcium levels
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System
Boston, Massachusetts, 02130
About this study
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.
Read the 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.
- Conditions
- Epilepsy, Bone Loss, Osteoporosis, Fractures
- Being tested
- Risedronate, Placebo + Calcium and Vitamin D
- Keywords
- osteoporosis, bone mineral density, fracture, antiepileptic drug, seizure, Prevention of bone loss, Prevention of osteoporosis, Prevention of Fractures
- Medical subject headings
- Epilepsy, Bone Diseases, Metabolic, Osteoporosis, Fractures, Bone, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisedronateDrug
Also called Actonel
35 mgs/week + calcium and vit d
Placebo + Calcium and Vitamin DDrug
Also called Placebo
sugar pill + calcium 1200mgs/day and vitamin d at least 800IU
| Study group | Role | What they receive |
|---|---|---|
| Risedronate | Active comparator | Active drug Receives: Drug: Risedronate |
| Placebo + Calcium and Vitamin D | Placebo comparator | All patients both on placebo and active bisphosphonate to receive calcium and vitamin D Receives: Drug: Placebo + Calcium and Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Bone Mineral Density
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.
Measured: 2 years
Secondary outcomes (1)
Vertebral Fractures
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2009 (estimated)
- Study startJun 2006
- Primary completionOct 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston VA Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Procter and Gamble, Alliance for Better Bone Health, VA Boston Healthcare System
- Responsible party
- Principal investigator, Antonio Lazzari, Boston VA Research Institute, Inc.
- Investigators
- Antonio A Lazzari, MD, Principal investigator, VA Boston HCSPhillip Dussault, Pharm D, Principal investigator, VA Boston HCSManisha Thakore, MD, Principal investigator, VA Boston HCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869622
- Sponsor's protocol ID
- VABHS IRB#1889
- Acronym
- ADOPT
- Status last verified
- Jul 2015
- First submitted
- 25 Mar 2009
- Last updated
- 24 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiepileptic Drugs and Osteoporotic Prevention Trial
- ClinicalTrials.gov ID
- NCT00869622
- Acronym / sponsor ID
- ADOPT / VABHS IRB#1889
- Conditions
- Epilepsy, Bone Loss, Osteoporosis, Fractures
- Keywords
- osteoporosis, bone mineral density, fracture, antiepileptic drug, seizure, Prevention of bone loss, Prevention of osteoporosis, Prevention of Fractures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Boston VA Research Institute, Inc.University, hospital or other
- Collaborators
- Procter and Gamble, Alliance for Better Bone Health, VA Boston Healthcare System
- Study start
- Jun 2006
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 26 Mar 2009 (estimated)
- Results
- Posted 24 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risedronate | Active comparator | Drug: RisedronateActive drug |
| Placebo + Calcium and Vitamin D | Placebo comparator | Drug: Placebo + Calcium and Vitamin DAll patients both on placebo and active bisphosphonate to receive calcium and vitamin D |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male gender
- Epilepsy
- Anti-epileptic drug treatment with phenytoin, or phenobarbital or valproate sodium
- Normal renal function and normal Vitamin D and calcium levels
Key exclusion criteria (8 listed)
- Female gender
- Organ transplant
- Use of oral glucocorticoids
- Renal insufficiency (eGFR < 30ml/min)
- Severe swallowing disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RisedronateAlso: Actonel35 mgs/week + calcium and vit d | Drug | Risedronate |
| Placebo + Calcium and Vitamin DAlso: Placebosugar pill + calcium 1200mgs/day and vitamin d at least 800IU | Drug | Placebo + Calcium and Vitamin D |
Primary outcome
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.
1 secondary outcome
Vertebral Fractures
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio A Lazzari, MD principal investigator
VA Boston HCS
Phillip Dussault, Pharm D principal investigator
VA Boston HCS
Manisha Thakore, MD principal investigator
VA Boston HCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Risedronate in people with Epilepsy and Bone Loss, run by Boston VA Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Bone Mineral Density (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2015.