Bone Status on Patients With Genetic Hemochromatosis: a 3... | NCT01556360

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

NCT01556360

Sponsor

Rennes University Hospital

Status

Completed

Last Update Posted

Jun 12, 2026Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Genetic Hemochromatosis

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 16, 2008Actual

Primary Completion Date

Jun 27, 2014Actual

Completion Date

Jun 27, 2014Actual

First Submitted Date

Mar 1, 2012

First Submission Date that Met QC Criteria

Mar 15, 2012

First Posted Date

Mar 16, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2026

Last Update Posted Date

Jun 12, 2026Actual

Name	Class
Ministry of Health, France	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Predictive value of iron overload on Bone Mineral Density		1 day
Number of vertebral fractures		3 years
Number of peripheral fractures

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patient with genetic hemochromatosis diagnosed in western France hospitals

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guggenbuhl Pascal, MD	Rennes University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Angers University Hospital		Angers		49933	France
Brest University Hospital

Condition Browse Module

MeSH Terms

ID	Term
D006432	Hemochromatosis
D019190	Iron Overload

Ancestor Terms

ID	Term
D008664	Metal Metabolism, Inborn Errors
D008661	Metabolism, Inborn Errors
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided