The Association Between Hyponatremia and Osteoporosis in Patients With Epilepsy.
NCT ID: NCT03371199
Last Updated: 2019-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
21 participants
INTERVENTIONAL
2017-12-01
2018-12-31
Brief Summary
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The study is a randomized, single blinded, placebo controlled study where participants will be randomized to either treatment with salt tablets or placebo tablets through 4 months. At the beginning and end of the 4 months bone markers will be measured.
The investigators null-hypothesis is that there will be no difference in bone markers before or after the intervention.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Sodium arm
Sodium tablets
Sodium chloride
Sodium chloride tablets, 250 mg
Placebo arm
Placebo tablets
Placebo Oral Tablet
Starch tablets
Interventions
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Sodium chloride
Sodium chloride tablets, 250 mg
Placebo Oral Tablet
Starch tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Known hyponatremia (2 subsequent s-sodium values \< 136 mmol/l)
* Age 18-80 years
* Danish speaking
* Signed form of prior consent
Exclusion Criteria
* Known osteoporosis. DXA scan \< -2.5 T-score. Z-score is used for patients 50 years or younger.
* Undergoing treatment for osteoporosis
* Undergoing treatment with salt tablets
* Known SIADH
* Severe concomitant disease such as cancer or ischemic heart disease
* Alcohol, drug or substance abuse
18 Years
80 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Sarah Seberg Diemar
Medical Doctor, ph.d. student, principal investigator
Principal Investigators
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Noémi B Andersen, DMSc, MD
Role: STUDY_CHAIR
Senoir consultant
Locations
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Rigshospitalet Glostrup
Glostrup Municipality, , Denmark
Countries
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References
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Fedorenko M, Wagner ML, Wu BY. Survey of risk factors for osteoporosis and osteoprotective behaviors among patients with epilepsy. Epilepsy Behav. 2015 Apr;45:217-22. doi: 10.1016/j.yebeh.2015.01.021. Epub 2015 Mar 24.
Maraka S, Kennel KA. Bisphosphonates for the prevention and treatment of osteoporosis. BMJ. 2015 Sep 2;351:h3783. doi: 10.1136/bmj.h3783.
Darba J, Kaskens L, Perez-Alvarez N, Palacios S, Neyro JL, Rejas J. Disability-adjusted-life-years losses in postmenopausal women with osteoporosis: a burden of illness study. BMC Public Health. 2015 Apr 2;15:324. doi: 10.1186/s12889-015-1684-7.
Wu FJ, Sheu SY, Lin HC. Osteoporosis is associated with antiepileptic drugs: a population-based study. Epileptic Disord. 2014 Sep;16(3):333-42. doi: 10.1684/epd.2014.0673.
Asconape JJ. Some common issues in the use of antiepileptic drugs. Semin Neurol. 2002 Mar;22(1):27-39. doi: 10.1055/s-2002-33046.
Vasikaran S, Eastell R, Bruyere O, Foldes AJ, Garnero P, Griesmacher A, McClung M, Morris HA, Silverman S, Trenti T, Wahl DA, Cooper C, Kanis JA; IOF-IFCC Bone Marker Standards Working Group. Markers of bone turnover for the prediction of fracture risk and monitoring of osteoporosis treatment: a need for international reference standards. Osteoporos Int. 2011 Feb;22(2):391-420. doi: 10.1007/s00198-010-1501-1. Epub 2010 Dec 24.
Sejling AS, Thorsteinsson AL, Pedersen-Bjergaard U, Eiken P. Recovery from SIADH-associated osteoporosis: a case report. J Clin Endocrinol Metab. 2014 Oct;99(10):3527-30. doi: 10.1210/jc.2014-1572. Epub 2014 Jun 27.
Sejling AS, Pedersen-Bjergaard U, Eiken P. Syndrome of inappropriate ADH secretion and severe osteoporosis. J Clin Endocrinol Metab. 2012 Dec;97(12):4306-10. doi: 10.1210/jc.2012-2031. Epub 2012 Oct 17.
Verbalis JG, Barsony J, Sugimura Y, Tian Y, Adams DJ, Carter EA, Resnick HE. Hyponatremia-induced osteoporosis. J Bone Miner Res. 2010 Mar;25(3):554-63. doi: 10.1359/jbmr.090827.
Barsony J, Sugimura Y, Verbalis JG. Osteoclast response to low extracellular sodium and the mechanism of hyponatremia-induced bone loss. J Biol Chem. 2011 Mar 25;286(12):10864-75. doi: 10.1074/jbc.M110.155002. Epub 2010 Dec 6.
Himmerkus N, Sievers B, Bleich M. Carbamazepine affects water and electrolyte homoeostasis in rat--similarities and differences to vasopressin antagonism. Nephrol Dial Transplant. 2012 Oct;27(10):3790-8. doi: 10.1093/ndt/gfs107. Epub 2012 May 4.
Other Identifiers
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57353
Identifier Type: -
Identifier Source: org_study_id
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