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

Genetic Hemochromatosis Clinical Trial

— FEROS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01556360
• Other study ID #: 2008-A000386-47
• Status: Completed
• Phase: N/A
• First received: March 1, 2012
• Last updated: May 26, 2015
• Start date: July 2008

Study information

• Verified date: May 2015
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Genetic Hemochromatosis
• Hemochromatosis

Locations

Country	Name	City	State
France	Angers University Hospital	Angers
France	Brest University Hospital	Brest
France	Nantes University Hospital	Nantes
France	Orleans Regional Hospital	Orleans
France	Poitiers University Hospital	Poitiers
France	Rennes University Hospital	Rennes

Sponsors (2)

Lead Sponsor	Collaborator
Rennes University Hospital	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density	Vertebral and hips Dual energy X-ray Absorptiometry (DXA)	Change from baseline in bone mineral density at three years	No
Secondary	Predictive value of iron overload on Bone Mineral Density		1 day	No
Secondary	Number of vertebral fractures		3 years	No
Secondary	Number of peripheral fractures		3 years	No
Secondary	Number and location of joint lesions detected by the examination (pain and swelling)		3 years	No
Secondary	Determination of genetic polymorphism of BMP 2 and 4		Baseline	No