Trial · NCT01030094
A Cross-sectional Study to Investigate the Effect of Topiramate on Bone and Mineral Metabolism in Female Participants With Epilepsy
NCT01030094, Completed, Janssen Korea, Ltd., Korea
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Cross-sectional Study to Investigate the Effect of Topiramate on Bone and Mineral Metabolism in Female Participants With Epilepsy. Trials, record NCT01030094. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01030094
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Cross-sectional Study to Investigate the Effect of Topiramate on Bone and Mineral Metabolism in Female Participants With Epilepsy
- NCT number
- NCT01030094
- Status
- Completed
- Enrollment
- 140 participants, actual
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Conditions
- Seizures, Convulsions, Epilepsy, Osteopenia, Osteoporosis
- Interventions
- Topiramate, Carbamazepine, Valproic acid, Normal control
- First posted
- 2009-12-11
- Last updated
- 2013-06-26
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute Concentration of Calcium in Serum and Random Urine | 24 hours | 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. |
| Primary | Absolute Concentration of 25-hydroxy Vitamin D, Osteocalcin, Carboxy-terminal Telopeptide of type 1 collagen (CTx) and Somatomedin-C (IGF-1) in Serum | 24 hours | 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. |
| Primary | Absolute Concentration of 1-alpha 25-dihydroxyvitamin D-3, Parathyroid Hormone (PTH) in Serum | 24 hours | 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. |
| Primary | Absolute Concentration of Bone-specific Alkaline Phosphatase (BSAP) in Serum | 24 hours | 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. |
| Primary | Absolute Concentration of Bicarbonate in Serum | 24 hours | 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. |
| Primary | Absolute Concentration of Calcium in Urine in 24 Hours | 24 hours | Absolute concentration of calcium in urine will be examined by urine test. |
| Secondary | Spine, Total hip and Femoral Neck Z-Score | 24 hours | 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. |
| Secondary | Percentage of Participants With Osteopenia and Osteoporosis Based on Spine T-score | 24 hours | 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. |
| Secondary | Percentage of Participants With Osteopenia and Osteoporosis Based on Spine Z-score | 24 hours | 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. |
| Secondary | Absolute Concentration of Phosphorus and Creatinine in Random Urine | 24 hours | Absolute concentration of phosphorus and creatinine in urine will be examined by urine test. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01030094
GET https://conductscience.org/api/trials/v1/NCT01030094/registered