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SeizuresNCT01030094

A Cross-sectional Study to Investigate the Effect of Topiramate on Bone and Mineral Metabolism in Female Participants With Epilepsy

An observational study of Seizures and Convulsions, run by Janssen Korea, Ltd., Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to investigate the influence of topiramate monotherapy on the bone and mineral metabolism markers, and bone density (the amount of mineral per square centimeter of bone ) in female participants with epilepsy (seizure disorder), before menopause (time in life when a woman stops having a… Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Seizures, Convulsions, Epilepsy
What is being tested?
Topiramate, Carbamazepine and Valproic acid
How many people
140 participants
Where
No sites listed yet
Study dates
Feb 2007to Apr 2009
Phase
Observational
Are there results?
None posted in the registry

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 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: Female participants with epilepsy who are receiving topiramate, carbamazepine or valproic acid monotherapy for more than one year.

Who may be able to join

  • Participants who agree to participate in this study
  • Female epileptic participants
  • Participants who are receiving topiramate, carbamazepine or valproic acid monotherapy for more than one year
  • Participants who are using proper contraceptive method (s) or have a negative pregnancy test result

Who cannot join

  • Participants with a motor function disorder
  • Participants with a disease which affects their skeleton including primary hyperparathyroidism, Paget's disease, multiple myeloma, liver and kidney disorder, thyroid disease, malabsorption disorder, diabetes, and malignancies
  • Participants who have taken within last one year, or are currently taking a drug which affects the bone and mineral metabolism such as vitamin D, calcium, anabolic steroids, bisphosphonates, calcitonin, glucocorticoids, and diuretics
  • Voluntary or surgical postmenopausal participants
  • Participants with amenorrhea for more than 6 months

About this study

Official title: A Cross-sectional, Comparative, Multi-center Study to Investigate the Effect of Topiramate Monotherapy on Markers of Bone Mineral Metabolism and Bone Mineral Density in Premenopausal Women With Epilepsy

The purpose of this study is to investigate the influence of topiramate monotherapy on the bone and mineral metabolism markers, and bone density (the amount of mineral per square centimeter of bone ) in female participants with epilepsy (seizure disorder), before menopause (time in life when a woman stops having a menstrual period), as compared with healthy participants and comparative group received either carbamazepine or valproic acid monotherapy for at least last one year.

Read the detailed description

This is a cross-sectional (observations or measurements made at a single point in time, usually at participant enrollment), multi-center (conducted in more than one center), and comparative study of topiramate monotherapy in female participants with epilepsy. Female participants must have received either topiramate, carbamazepine, or valproic acid monotherapy for more than one year for the treatment of epilepsy. Blood samples will be obtained from fasting participants to investigate the effect of study drug on the bone and mineral metabolism markers, and bone density compared to healthy participants and comparative group (carbamazepine and valproic acid monotherapy). Bone mineral density will be measured from the participants' lumbar spine or femur. A survey of food intake and physical activity for the participants will be performed using a standardized validated detailed questionnaire. The post-study visit (or follow up phone contact) will be performed for the occurrence of serious adverse events (SAE) for safety evaluation. Participants' safety will be monitored throughout the study.

Being tested
Topiramate, Carbamazepine, Valproic acid, Normal control
Keywords
Topiramate, Carbamazepine, Valproic acid, Epilepsy, Bone mineral density, Monotherapy
Medical subject headings
Seizures, Epilepsy, Bone Diseases, Metabolic, Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TopiramateDrug

    This is an observational study. Female participants with epilepsy will be observed, who were receiving topiramate for more than one year.

  • CarbamazepineDrug

    This is an observational study. Female participants with epilepsy will be observed, who were receiving carbamazepine for more than one year.

  • Valproic acidDrug

    This is an observational study. Female participants with epilepsy will be observed, who were receiving valproic acid for more than one year.

  • Normal controlDrug

    This is an observational study. Healthy female participants will be observed in Normal control group.

Study groups in NCT01030094
Study groupRoleWhat they receive
TopiramateFemale participants with epilepsy will be observed, who were receiving topiramate for more than one year.
Receives: Drug: Topiramate
CarbamazepineFemale participants with epilepsy will be observed, who were receiving carbamazepine for more than one year.
Receives: Drug: Carbamazepine
Valproic acidFemale participants with epilepsy will be observed, who were receiving valproic acid for more than one year.
Receives: Drug: Valproic acid
Normal ControlHealthy female participants will be observed in Normal control group.
Receives: Drug: Normal control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absolute Concentration of Calcium in Serum and Random Urine

    Bone and mineral metabolic marker represents the structure, cyclical metabolism, and hormone regulation of bone. Urinary calcium is one of the indicators of bone resorption (bone loss due to osteoclastic activity). Absolute concentration of calcium in serum and random urine will be assessed.

    Measured: 24 hours

  2. Absolute Concentration of 25-hydroxy Vitamin D, Osteocalcin, Carboxy-terminal Telopeptide of type 1 collagen (CTx) and Somatomedin-C (IGF-1) in Serum

    Osteocalcin is a vitamin K-dependent calcium-binding protein synthesized by osteoblasts and found primarily in bones. Serum osteocalcin measurements provide a noninvasive specific marker of bone metabolism. CTx is marker for bone resorption (bone loss due to osteoclastic activity). IGF-1 has growth-regulating, insulin-like, and mitogenic activities. Absolute concentration of 25-hydroxy vitamin D, osteocalcin, carboxy-terminal telopeptide of type 1 collagen (CTx) and somatomedin-C (IGF-1) in serum will be assessed.

    Measured: 24 hours

  3. Absolute Concentration of 1-alpha 25-dihydroxyvitamin D-3, Parathyroid Hormone (PTH) in Serum

    Bone and mineral metabolic marker represents the structure, cyclical metabolism, and hormone regulation of bone. 1-alpha 25-dihydroxyvitamin D-3 (vitamin D-3) and Parathyroid hormone (PTH) were assessed. The PTH maintains intracellular calcium levels in the body.

    Measured: 24 hours

  4. Absolute Concentration of Bone-specific Alkaline Phosphatase (BSAP) in Serum

    Bone and mineral metabolic marker represents the structure, cyclical metabolism, and hormone regulation of bone. Bone-specific alkaline phosphatase (BSAP) reflects formation of organic matrix in bone. Absolute concentration of BSAP in Serum will be assessed.

    Measured: 24 hours

  5. Absolute Concentration of Bicarbonate in Serum

    Bicarbonate levels in the blood are an index of the alkali reserve or buffering capacity. Difference in Bicarbonate level between topiramate, carbamazepine and valproic acid monotherapy groups will be assessed.

    Measured: 24 hours

  6. Absolute Concentration of Calcium in Urine in 24 Hours

    Absolute concentration of calcium in urine will be examined by urine test.

    Measured: 24 hours

Secondary outcomes (7)

  1. Spine, Total hip and Femoral Neck Z-Score

    Z-score is number of standard deviations a participant's bone mineral density (BMD) differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are "best values" and negative values are "worst values". Z-score will be evaluated for spine, hip and femoral neck.

    Measured: 24 hours

  2. Percentage of Participants With Osteopenia and Osteoporosis Based on Spine T-score

    Osteoporosis means reduction of bone mass without alteration in the composition of bone, leading to fractures. Osteopenia is a metabolic bone disease. The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a "normal, healthy, 30-year-old female". The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD. Percentage of participants with osteopenia and osteoporosis based on spine T-score will be assessed.

    Measured: 24 hours

  3. Percentage of Participants With Osteopenia and Osteoporosis Based on Spine Z-score

    Osteoporosis means reduction of bone mass without alteration in the composition of bone, leading to fractures. Osteopenia is a metabolic bone disease. The Z-score is number of standard deviations a participant's bone mineral density (BMD) differs from the average BMD of their age, sex, and ethnicity. Positive scores indicate BMD above the mean; Positive values are "best values" and negative values are "worst values". Z-score will be evaluated for spine, hip and femoral neck. Percentage of participants with osteopenia and osteoporosis based on spine Z-score will be assessed.

    Measured: 24 hours

  4. Absolute Concentration of Phosphorus and Creatinine in Random Urine

    Absolute concentration of phosphorus and creatinine in urine will be examined by urine test.

    Measured: 24 hours

  5. Absolute concentration of Sodium in Random Urine

    Absolute concentration of sodium in urine will be examined by urine test.

    Measured: 24 hours

  6. Absolute Concentration of Phosphorus and Creatinine in 24 Hour Urine

    Absolute concentration of phosphorus and creatinine in 24 hour urine will be examined by urine test.

    Measured: 24 hours

  7. Absolute concentration of Sodium in 24 Hour Urine

    Absolute concentration of sodium in 24 hour urine will be examined by urine test.

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2009 (estimated)
  2. Study startFeb 2007
  3. Primary completionApr 2009
  4. Study completionApr 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01030094
Sponsor's protocol ID
CR015856
Other IDs
TOP-KOR-31
Status last verified
Jun 2013
First submitted
10 Dec 2009
Last updated
26 Jun 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Seizures and Convulsions, run by Janssen Korea, Ltd., Korea.

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 5 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 26 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Absolute Concentration of Calcium in Serum and Random Urine (time frame: 24 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01030094.

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 26 Jun 2013.

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