The Association Between Hyponatremia and Osteoporosis in Patients With Epilepsy.

Hyponatremia Clinical Trial

Official title:

The Effect of Normalization of Sodium on Bone Markers in Patients With Epilepsy. A Randomized Single-blinded Placebo-controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03371199
• Other study ID #: 57353
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Bone Diseases
• Bone Diseases, Metabolic
• Epilepsy
• Hyponatremia
• Metabolic Bone Disease

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 all — Click 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