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CompletedNCT01556360FEROSUpdated Jun 12, 2026

Bone Status on Patients With Genetic Hemochromatosis: a 3 Years Descriptive and Evolutionary Study

An observational study in Genetic Hemochromatosis, sponsored by Rennes University Hospital. Completed at 6 sites in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-12.

Sponsored by Rennes University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Genetic Hemochromatosis

Keywords

  • genetic hemochromatosis
  • Iron overload
  • C282 homozygosity
03

In context

Hemochromatosis

55 studies on the registry are indexed under Hemochromatosis; 4 are open to participants now.

This study's enrollment of 100 is above the median of 70 across 19 observational studies indexed under Hemochromatosis.

Browse Hemochromatosis studies →

Lead sponsor

Rennes University Hospital is the lead sponsor of 451 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient with genetic hemochromatosis diagnosed in western France hospitals

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients between 18 and 80 years
  • C282 homozygosity

Exclusion criteria

Exclusion Criteria:

  • 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
  • inclusion in another study incompatible with this one
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (actual)
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Bone mineral density

    Vertebral and hips Dual energy X-ray Absorptiometry (DXA)

    Time frame: Change from baseline in bone mineral density at three years

Secondary outcomes

  1. Predictive value of iron overload on Bone Mineral Density

    Time frame: 1 day

  2. Number of vertebral fractures

    Time frame: 3 years

  3. Number of peripheral fractures

    Time frame: 3 years

  4. Number and location of joint lesions detected by the examination (pain and swelling)

    Time frame: 3 years

  5. Determination of genetic polymorphism of BMP 2 and 4

    Time frame: Baseline

07

Study locations

6 sites
  • Angers University Hospital
    Angers, 49933, France
  • Brest University Hospital
    Brest, 29609, France
  • Nantes University Hospital
    Nantes, 44093, France
  • Orleans Regional Hospital
    Orléans, 45100, France
  • Poitiers University Hospital
    Poitiers, 86021, France
  • Rennes University Hospital
    Rennes, 35033, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2008 to primary completion in Jun 2014, 71 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 1, 2012
First posted
Mar 16, 2012
StartActual
Jul 16, 2008
Primary completionActual
Jun 27, 2014
CompletionActual
Jun 27, 2014
Last update
Jun 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01556360
Collaborators
Ministry of Health, France
Responsible party
Sponsor
First posted
Mar 16, 2012
Start date
Jul 16, 2008
Primary completion
Jun 27, 2014
Completion
Jun 27, 2014
Last update
Jun 12, 2026

Study contacts

Guggenbuhl Pascal, MD
principal investigator · Rennes University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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