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The Association Between Hyponatremia and Osteoporosis in Patients With Epilepsy.

Primary Purpose

Hyponatremia, Metabolic Bone Disease

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Sodium chloride
Placebo Oral Tablet
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hyponatremia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rigshospitalet Glostrup

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Sodium arm

Placebo arm

Arm Description

Sodium tablets

Placebo tablets

Outcomes

Primary Outcome Measures

CTX1 change
bone markers

Secondary Outcome Measures

P1NP change
Bone markers
DXA scan change
Density measurements
Cognitive function change
Epitrack test, scale from 9-49 (9 worst score - 49 best score)
Life quality change
Quoli 31, scale from 0-100 (0 lowest life quality - 100 best life quality)
Change in daily pains
VAS from 0-10 (0 no pains - 10 maximum pain)

Full Information

First Posted
November 30, 2017
Last Updated
March 26, 2019
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT03371199
Brief Title
The Association Between Hyponatremia and Osteoporosis in Patients With Epilepsy.
Official Title
The Effect of Normalization of Sodium on Bone Markers in Patients With Epilepsy. A Randomized Single-blinded Placebo-controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyponatremia, Metabolic Bone Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sodium arm
Arm Type
Active Comparator
Arm Description
Sodium tablets
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
Placebo tablets
Intervention Type
Drug
Intervention Name(s)
Sodium chloride
Intervention Description
Sodium chloride tablets, 250 mg
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Other Intervention Name(s)
Strarch tablets
Intervention Description
Starch tablets
Primary Outcome Measure Information:
Title
CTX1 change
Description
bone markers
Time Frame
At baseline and after 4 months intervention
Secondary Outcome Measure Information:
Title
P1NP change
Description
Bone markers
Time Frame
At baseline and after 4 months intervention
Title
DXA scan change
Description
Density measurements
Time Frame
At baseline and after 4 months intervention
Title
Cognitive function change
Description
Epitrack test, scale from 9-49 (9 worst score - 49 best score)
Time Frame
At baseline and after 4 months intervention
Title
Life quality change
Description
Quoli 31, scale from 0-100 (0 lowest life quality - 100 best life quality)
Time Frame
At baseline and after 4 months intervention
Title
Change in daily pains
Description
VAS from 0-10 (0 no pains - 10 maximum pain)
Time Frame
At baseline and after 4 months intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noémi B Andersen, DMSc, MD
Organizational Affiliation
Senoir consultant
Official's Role
Study Chair
Facility Information:
Facility Name
Rigshospitalet Glostrup
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We have currently no plan to share individual patient data, but if relevant if relevant it could occur.
Citations:
PubMed Identifier
25812937
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.
Results Reference
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PubMed Identifier
26333528
Citation
Maraka S, Kennel KA. Bisphosphonates for the prevention and treatment of osteoporosis. BMJ. 2015 Sep 2;351:h3783. doi: 10.1136/bmj.h3783.
Results Reference
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PubMed Identifier
25880810
Citation
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.
Results Reference
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PubMed Identifier
25166266
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.
Results Reference
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PubMed Identifier
12170391
Citation
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.
Results Reference
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PubMed Identifier
21184054
Citation
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.
Results Reference
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PubMed Identifier
24971663
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.
Results Reference
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PubMed Identifier
23076350
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.
Results Reference
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PubMed Identifier
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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.
Results Reference
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PubMed Identifier
21135109
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.
Results Reference
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PubMed Identifier
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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.
Results Reference
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The Association Between Hyponatremia and Osteoporosis in Patients With Epilepsy.

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