Healthy Men and Non- Pregnant WomenNCT02097888
Influence of Erythropoietin on Bone Marrow Microenvironment
An observational study of Healthy Men and Non- Pregnant Women, run by Kantonsspital Baselland Bruderholz at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Men and Non- Pregnant Women
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2011to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Residents living < 400m over sea level and >1500m over sea level
Who may be able to join
- healthy men and non-pregnant women, ages ≥18-40 years and ≥ 60 years living in the predefined area
Who cannot join
- Known bone pathology including osteoporosis, known haematological disease, known renal disease, heart insufficiency, pulmonal disease
- pregnancy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Kantonsspital Baselland / Bruderholz
Bruderholz, 4101
Sandrine Meyer-Monard, PD Dr. med., 0041 61 436 2203, sandrine.meyer@ksbl.ch
Helga Schneider, 0041 61 436 31 44, helga.schneider@ksbl.ch
About this study
Official title: Influence of Erythropoietin on Bone Marrow Microenvironment: A Pilot Study
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.
- Conditions
- Healthy Men and Non- Pregnant Women
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of EPO level between control groups
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startDec 2011
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Men and Non- Pregnant WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Baselland Bruderholz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. med. Sandrine Meyer-Monard, Kantonsspital Baselland Bruderholz
- Investigators
- Sandrine Meyer-Monard, PD Dr. med., Principal investigator, Kantonsspital Baselland / Bruderholz, Department of Medicine, Studienabteilung, CH-4101 Bruderholz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097888
- Sponsor's protocol ID
- KSBLB: 252/11
- Status last verified
- Mar 2014
- First submitted
- 19 Mar 2014
- Last updated
- 27 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Erythropoietin on Bone Marrow Microenvironment: A Pilot Study
- ClinicalTrials.gov ID
- NCT02097888
- Acronym / sponsor ID
- KSBLB: 252/11
- Conditions
- Healthy Men and Non- Pregnant Women
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Kantonsspital Baselland BruderholzUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 27 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Residents living < 400m over sea level and >1500m over sea level
Key inclusion criteria (1 listed)
- healthy men and non-pregnant women, ages ≥18-40 years and ≥ 60 years living in the predefined area
Key exclusion criteria (2 listed)
- Known bone pathology including osteoporosis, known haematological disease, known renal disease, heart insufficiency, pulmonal disease
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference of EPO level between control groups
Time frame: up to 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandrine Meyer-Monard, PD Dr. med. principal investigator
Kantonsspital Baselland / Bruderholz, Department of Medicine, Studienabteilung, CH-4101 Bruderholz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Men and Non- Pregnant Women, run by Kantonsspital Baselland Bruderholz at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandrine Meyer-Monard, PD Dr. med. (041 61 436 22 03, sandrine.meyer@ksbl.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of EPO level between control groups (time frame: up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2014.