Influence of Erythropoietin on Bone Marrow Microenvironment | NCT02097888

Studies
Influence of Erythropoietin on Bone Marrow Microenvironment

NCT02097888

Sponsor

Kantonsspital Baselland Bruderholz

Status

Unknown status

Last Update Posted

Mar 27, 2014Estimated

Enrollment

120Estimated

Phase

Not provided

Conditions

Healthy Men and Non- Pregnant Women

Interventions

Not provided

Countries

Switzerland

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 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Dec 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Mar 19, 2014

First Submission Date that Met QC Criteria

Mar 24, 2014

First Posted Date

Mar 27, 2014Estimated

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 24, 2014

Last Update Posted Date

Mar 27, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

PD Dr. med. Sandrine Meyer-Monard, PD Dr. med., Kantonsspital Baselland BruderholzPrincipal Investigator

Lead Sponsor

Kantonsspital Baselland BruderholzOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This will be a prospective observational study. The investigators will compare Erythropoietin (Epo) levels, erythropoiesis, and regulators of erythropoiesis, bone imaging and bone metabolism in healthy volunteers living at different altitudes.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

120Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference of EPO level between control groups		up to 4 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy men and non-pregnant women, ages ≥18-40 years and ≥ 60 years living in the predefined area
Exclusion Criteria:
Known bone pathology including osteoporosis, known haematological disease, known renal disease, heart insufficiency, pulmonal disease
pregnancy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Residents living < 400m over sea level and >1500m over sea level

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sandrine Meyer-Monard, PD Dr. med.	Contact	041 61 436 22 03		sandrine.meyer@ksbl.ch
Helga Schneider	Contact	0041 61 436 31 44		helga.schneider@ksbl.ch

Overall Officials

Name	Affiliation	Role
Sandrine Meyer-Monard, PD Dr. med.	Kantonsspital Baselland / Bruderholz, Department of Medicine, Studienabteilung, CH-4101 Bruderholz	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kantonsspital Baselland / Bruderholz	Recruiting	Bruderholz		4101	Switzerland