The Association Between Hyponatremia and Osteoporosis in... | NCT03371199

Studies
The Association Between Hyponatremia and Osteoporosis in Patients With Epilepsy.

NCT03371199

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

Mar 28, 2019Actual

Enrollment

21Actual

Phase

Not Applicable

Conditions

Hyponatremia
Metabolic Bone Disease

Interventions

Sodium chloride
Placebo Oral Tablet

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2017Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

Nov 30, 2017

First Submission Date that Met QC Criteria

Dec 7, 2017

First Posted Date

Dec 13, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2019

Last Update Posted Date

Mar 28, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sarah Seberg Diemar, Medical Doctor, ph.d. student, principal investigator, Rigshospitalet, DenmarkPrincipal Investigator

Lead Sponsor

Rigshospitalet, DenmarkOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sodium arm	Active Comparator	Sodium tablets	Drug: Sodium chloride
Placebo arm	Placebo Comparator	Placebo tablets	Drug: Placebo Oral Tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sodium chloride	Drug	Sodium chloride tablets, 250 mg	Sodium arm
Placebo Oral Tablet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CTX1 change	bone markers	At baseline and after 4 months intervention

Secondary Outcomes

Measure	Description	Time Frame
P1NP change	Bone markers	At baseline and after 4 months intervention
DXA scan change	Density measurements	At baseline and after 4 months intervention

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Noémi B Andersen, DMSc, MD	Senoir consultant	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet Glostrup		Glostrup Municipality		2600	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25812937	Background	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.
26333528	Background	Maraka S, Kennel KA. Bisphosphonates for the prevention and treatment of osteoporosis. BMJ. 2015 Sep 2;351:h3783. doi: 10.1136/bmj.h3783.

ID	Term
D007010	Hyponatremia
D001851	Bone Diseases, Metabolic

ID	Term
D014883	Water-Electrolyte Imbalance
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D001847	Bone Diseases

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals