Mother Daughter Bone Microarchitecture

NCT ID: NCT01258036

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1040 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-04

Study Completion Date

2012-02-29

Brief Summary

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The aim of this study is to analyze the hereditary determinism of bone microarchitecture measured at the distal radius and distal tibia from a case control-study of mother-daughter pairs.

Detailed Description

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Many factors influence the risk of osteoporosis but one of the most important is a positive family history, emphasizing the importance of genetics in the pathogenesis of osteoporosis. Till now, most genetic studies in osteoporosis have focused on the phenotype of BMD. However, areal BMD (bone quantity per unit bone area measured) does not provide information regarding bone distribution (between cortical and cancellous compartments) or bone microarchitecture (trabecular number, thickness, spacing and distribution) and cortical (thickness, porosity). We are planning to analyze the hereditary determinism of bone microarchitecture assessed non invasively with HR pQCT at the distal radius and the distal tibia in a case-control study with fractured and not fractured mothers and their daughters. Additionally, the role of the bone turnover, hormones involved in regulating bone metabolism , bone geometry measured at the proximal femur and bone strength estimated by finite element analysis (μFE)in the hereditary determinism of bone fragility will be analyzed.

Conditions

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Bone Fragility

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Fractured Mothers

Fractured Mothers and their daughters

HRpQCT

Intervention Type RADIATION

High Resolution peripheral Quantitative Computerized tomography

Sampling

Intervention Type BIOLOGICAL

Urine and blood samples

Bone absorptiometry

Intervention Type RADIATION

DXA at the lumbar spine, hip, radius and whole body

Non fractured mothers

Mothers non fractured and their daughters

HRpQCT

Intervention Type RADIATION

High Resolution peripheral Quantitative Computerized tomography

Sampling

Intervention Type BIOLOGICAL

Urine and blood samples

Bone absorptiometry

Intervention Type RADIATION

DXA at the lumbar spine, hip, radius and whole body

Interventions

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HRpQCT

High Resolution peripheral Quantitative Computerized tomography

Intervention Type RADIATION

Sampling

Urine and blood samples

Intervention Type BIOLOGICAL

Bone absorptiometry

DXA at the lumbar spine, hip, radius and whole body

Intervention Type RADIATION

Other Intervention Names

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XTreme CT,Scanco Medical, Bassersdorf, Switzerland Bone markers, hormones Hologic, Waltham,MA, USA

Eligibility Criteria

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Inclusion Criteria

* Case mothers: postmenopausal women who have at least one bone fragility fracture confirmed by radiological examination or by a surgical report. Fragility fracture is a fracture that occurs as a result of a fall from standing height or less. Fractures of the skull, fingers and toes will be excluded.
* Control mothers: menopausal women not having suffered from bone fragility fracture.
* Daughters: Women aged 20 and older (postmenopausal or not), biological daughters of participating mothers. Several daughters from the same mother may be included.

Mothers and some daughters are recruited from the OFELY (Os des FEmmes de LYon) cohort or the FMC (Filière MédicoChirurgicale).

Exclusion Criteria

* Adoptive daughters
* Nonmenopausal mothers
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elisabeth Sornay-Rendu, MD

Role: PRINCIPAL_INVESTIGATOR

Institut National de la Santé Et de la Recherche Médicale, France

Roland D Chapurlat, MD PHD

Role: STUDY_DIRECTOR

Institut National de la Santé Et de la Recherche Médicale, France

Locations

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Unité Inserm 831, Pavillon F, Hôpital Edouard Herriot

Lyon, , France

Site Status

Countries

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France

References

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Nagy H, Sornay-Rendu E, Boutroy S, Vilayphiou N, Szulc P, Chapurlat R. Impaired trabecular and cortical microarchitecture in daughters of women with osteoporotic fracture: the MODAM study. Osteoporos Int. 2013 Jun;24(6):1881-9. doi: 10.1007/s00198-012-2223-3. Epub 2012 Nov 23.

Reference Type RESULT
PMID: 23179577 (View on PubMed)

Other Identifiers

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2009-A01295-52

Identifier Type: REGISTRY

Identifier Source: secondary_id

C09-37

Identifier Type: -

Identifier Source: org_study_id

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