The Association Between Hyponatremia and Osteoporosis in Patients With Epilepsy.

NCT03371199 | Completed

• 1 other identifier: 57353
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyponatremia; Metabolic Bone Disease

Outcome Measures

Primary Outcomes (1)

• CTX1 change

  bone markers

  At baseline and after 4 months intervention

Secondary Outcomes (5)

• P1NP change

  At baseline and after 4 months intervention

• DXA scan change

  At baseline and after 4 months intervention

• Cognitive function change

  At baseline and after 4 months intervention

• Life quality change

  At baseline and after 4 months intervention

• Change in daily pains

  At baseline and after 4 months intervention

Study Arms (2)

Sodium arm

ACTIVE COMPARATOR

Sodium tablets

Drug: Sodium chloride

Placebo arm

PLACEBO COMPARATOR

Placebo tablets

Drug: Placebo Oral Tablet

Interventions

Sodium chloride DRUG

Sodium chloride tablets, 250 mg

Sodium arm

Placebo Oral Tablet DRUG

Starch tablets

Also known as: Strarch tablets

Placebo arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet Glostrup

Glostrup Municipality, 2600, Denmark

Location

Related Publications (11)

• 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.

  PMID: 25812937 BACKGROUND

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

  PMID: 26333528 BACKGROUND

• 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.

  PMID: 25880810 BACKGROUND

• 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.

  PMID: 25166266 BACKGROUND

• 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.

  PMID: 12170391 BACKGROUND

• 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.

  PMID: 21184054 BACKGROUND

• 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.

  PMID: 24971663 BACKGROUND

• 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.

  PMID: 23076350 BACKGROUND

• 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.

  PMID: 19751154 BACKGROUND

• 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.

  PMID: 21135109 BACKGROUND

• 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.

  PMID: 22561584 BACKGROUND

MeSH Terms

Conditions

Hyponatremia; Bone Diseases, Metabolic

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Noémi B Andersen, DMSc, MD

  Senoir consultant

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, ph.d. student, principal investigator

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: December 13, 2017
• Study Start: December 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: March 28, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)