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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01556360

Acronym

FEROS

Enrollment

100

Registered

2012-03-16

Start date

2008-07-16

Completion date

2014-06-27

Last updated

2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genetic Hemochromatosis

Keywords

genetic hemochromatosis, Iron overload, C282 homozygosity

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Patients between 18 and 80 years * C282 homozygosity

Exclusion criteria

* 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 * inclusion in another study incompatible with this one

Design outcomes

Primary

Measure	Time frame	Description
Bone mineral density	Change from baseline in bone mineral density at three years	Vertebral and hips Dual energy X-ray Absorptiometry (DXA)

Secondary

Measure	Time frame
Predictive value of iron overload on Bone Mineral Density	1 day
Number of vertebral fractures	3 years
Number of peripheral fractures	3 years
Number and location of joint lesions detected by the examination (pain and swelling)	3 years
Determination of genetic polymorphism of BMP 2 and 4	Baseline

Countries

France

Contacts

PRINCIPAL_INVESTIGATORGuggenbuhl Pascal, MD

Rennes University Hospital

Outcome results