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Mother Daughter Bone Microarchitecture (MODAM)

I

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

Status

Completed

Conditions

Bone Fragility

Treatments

Radiation: HRpQCT
Radiation: Bone absorptiometry
Biological: Sampling

Study type

Observational

Funder types

Other

Identifiers

NCT01258036
C09-37
2009-A01295-52 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

1,040 patients

Sex

Female

Ages

20+ years old

Volunteers

No Healthy Volunteers

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

Trial design

1,040 participants in 2 patient groups

Fractured Mothers
Description:
Fractured Mothers and their daughters
Treatment:
Biological: Sampling
Radiation: Bone absorptiometry
Radiation: HRpQCT
Non fractured mothers
Description:
Mothers non fractured and their daughters
Treatment:
Biological: Sampling
Radiation: Bone absorptiometry
Radiation: HRpQCT

Trial contacts and locations

1

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Central trial contact

Elisabeth Sornay-Rendu, MD

Data sourced from clinicaltrials.gov

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