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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03371199
Other study ID # 57353
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2017
Est. completion date December 31, 2018

Study information

Verified date March 2019
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study investigates the association between normalization of serum sodium levels and bone markers in patients with epilepsy and chronic hyponatremia.

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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Epilepsy requiring treatment for at least 2 years

- Known hyponatremia (2 subsequent s-sodium values < 136 mmol/l)

- Age 18-80 years

- Danish speaking

- Signed form of prior consent

Exclusion Criteria:

- Pregnancy and breastfeeding

- 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

Study Design


Intervention

Drug:
Sodium chloride
Sodium chloride tablets, 250 mg
Placebo Oral Tablet
Starch tablets

Locations

Country Name City State
Denmark Rigshospitalet Glostrup Glostrup

Sponsors (1)

Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (11)

Asconapé JJ. Some common issues in the use of antiepileptic drugs. Semin Neurol. 2002 Mar;22(1):27-39. Review. — View Citation

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. — View Citation

Darbà J, Kaskens L, Pérez-Álvarez 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. — View Citation

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. — View Citation

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. — View Citation

Maraka S, Kennel KA. Bisphosphonates for the prevention and treatment of osteoporosis. BMJ. 2015 Sep 2;351:h3783. doi: 10.1136/bmj.h3783. Review. — View Citation

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. — View Citation

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. — View Citation

Vasikaran S, Eastell R, Bruyère 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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary CTX1 change bone markers At baseline and after 4 months intervention
Secondary P1NP change Bone markers At baseline and after 4 months intervention
Secondary DXA scan change Density measurements At baseline and after 4 months intervention
Secondary Cognitive function change Epitrack test, scale from 9-49 (9 worst score - 49 best score) At baseline and after 4 months intervention
Secondary Life quality change Quoli 31, scale from 0-100 (0 lowest life quality - 100 best life quality) At baseline and after 4 months intervention
Secondary Change in daily pains VAS from 0-10 (0 no pains - 10 maximum pain) At baseline and after 4 months intervention
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