Genetic HemochromatosisFEROSNCT01556360
Bone Status on Patients With Genetic Hemochromatosis: a 3 Years Descriptive and Evolutionary Study
An observational study of Genetic Hemochromatosis, run by Rennes University Hospital at 6 sites in France.
Trial summary
The purpose of this study is to describe bone status on patients with genetic hemochromatosis, at diagnostic time and his evolution under treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Genetic Hemochromatosis
- How many people
- 100 participants
- Where
- 6 sitesFrance
- Study dates
- 16 Jul 2008to 27 Jun 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with genetic hemochromatosis diagnosed in western France hospitals
Who may be able to join
- Patients between 18 and 80 years
- C282 homozygosity
Who cannot join
- corticosteroids during the last 3 months
- following treatments during the last 6 months : anabolic steroids, growth hormone, hormone therapy for menopause, tibolone, raloxifene.
- following treatments during inclusion or in the last 6 month : teriparatide, parathormone, fluor, strontium ranelate, biphosphonate.
- cancer or evolutionary hemopathy (including monoclonal gammopathy)
- pregnancy at inclusion time
- treated osteoporosis
- patient in wich follow up seems hard
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Angers University Hospital
Angers, 49933
Brest University Hospital
Brest, 29609
Nantes University Hospital
Nantes, 44093
Orleans Regional Hospital
Orléans, 45100
Poitiers University Hospital
Poitiers, 86021
Rennes University Hospital
Rennes, 35033
About this study
Official title: Bone Status on Patients With Genetic Hemochromatosis : a 3 Years Descriptive and Evolutionary Study.
The purpose of this study is to describe bone status on patients with genetic hemochromatosis, at diagnostic time and his evolution under treatment.
Read the detailed description
Bone diseases have been recognized recently as complications of genetic hemochromatosis. Further studies are needed to describe the role of iron in bone injuries. The purpose of this study is to describe bone status on patients with genetical hemochromatosis, at diagnostic time and his evolution under treatment.
- Conditions
- Genetic Hemochromatosis
- Keywords
- genetic hemochromatosis, Iron overload, C282 homozygosity
- Medical subject headings
- Hemochromatosis, Iron Overload
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density
Vertebral and hips Dual energy X-ray Absorptiometry (DXA)
Measured: Change from baseline in bone mineral density at three years
Secondary outcomes (5)
Predictive value of iron overload on Bone Mineral Density
Measured: 1 day
Number of vertebral fractures
Measured: 3 years
Number of peripheral fractures
Measured: 3 years
Number and location of joint lesions detected by the examination (pain and swelling)
Measured: 3 years
Determination of genetic polymorphism of BMP 2 and 4
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study start16 Jul 2008
- Primary completion27 Jun 2014
- Study completion27 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic HemochromatosisStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Guggenbuhl Pascal, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556360
- Sponsor's protocol ID
- 2008-A000386-47
- Acronym
- FEROS
- Status last verified
- Jun 2026
- First submitted
- 1 Mar 2012
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Status on Patients With Genetic Hemochromatosis : a 3 Years Descriptive and Evolutionary Study.
- ClinicalTrials.gov ID
- NCT01556360
- Acronym / sponsor ID
- FEROS / 2008-A000386-47
- Conditions
- Genetic Hemochromatosis
- Keywords
- genetic hemochromatosis, Iron overload, C282 homozygosity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 16 Jul 2008 (actual)
- Primary completion
- 27 Jun 2014 (actual)
- Study completion
- 27 Jun 2014 (actual)
- First posted
- 16 Mar 2012 (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.
The purpose of this study is to describe bone status on patients with genetic hemochromatosis, at diagnostic time and his evolution under treatment.
Detailed description
Bone diseases have been recognized recently as complications of genetic hemochromatosis. Further studies are needed to describe the role of iron in bone injuries. The purpose of this study is to describe bone status on patients with genetical hemochromatosis, at diagnostic time and his evolution under treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with genetic hemochromatosis diagnosed in western France hospitals
Key inclusion criteria (2 listed)
- Patients between 18 and 80 years
- C282 homozygosity
Key exclusion criteria (7 listed)
- corticosteroids during the last 3 months
- following treatments during the last 6 months : anabolic steroids, growth hormone, hormone therapy for menopause, tibolone, raloxifene.
- following treatments during inclusion or in the last 6 month : teriparatide, parathormone, fluor, strontium ranelate, biphosphonate.
- cancer or evolutionary hemopathy (including monoclonal gammopathy)
- pregnancy at inclusion time
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
Bone mineral density
Time frame: Change from baseline in bone mineral density at three years
Vertebral and hips Dual energy X-ray Absorptiometry (DXA)
5 secondary outcomes
Predictive value of iron overload on Bone Mineral Density
Time frame: 1 day
Number of vertebral fractures
Time frame: 3 years
Number of peripheral fractures
Time frame: 3 years
Number and location of joint lesions detected by the examination (pain and swelling)
Time frame: 3 years
Determination of genetic polymorphism of BMP 2 and 4
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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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.
Guggenbuhl Pascal, MD principal investigator
Rennes University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genetic Hemochromatosis, run by Rennes University Hospital at 6 sites in France.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density (time frame: Change from baseline in bone mineral density at three 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 12 Jun 2026.