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Completed

NCT Number: NCT01258036

Mother Daughter Bone Microarchitecture

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.

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Key information

Conditions

Age range

20 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Unité Inserm 831, Pavillon F, Hôpital Edouard Herriot

Lyon, 69437, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HRpQCT

Radiation

High Resolution peripheral Quantitative Computerized tomography

Other names: XTreme CT,Scanco Medical, Bassersdorf, Switzerland

Sampling

Biological

Urine and blood samples

Other names: Bone markers, hormones

Bone absorptiometry

Radiation

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

Other names: Hologic, Waltham,MA, USA

Primary outcomes

  1. Role of bone microarchitecture in the hereditary determinism of bone fragility

    Time frame: 18 months

    Comparison of bone microarchitecture parameters from high resolution peripheral quantitative computer tomography (HRpQCT)between daughters according to the fracture status of their mother.

Secondary outcomes

  1. Role of Bone mineral density in the hereditary determinism of bone fragility

    Time frame: 18 months

    Comparison of BMD from DXA at the hip, the lumbar spine, the forearm and whole body, between daughters according to the fracture status of their mother.

  2. Role of bone turnover and hormones in the hereditary determinism of bone fragility

    Time frame: 24 months

    Comparison of Bone markers and hormone levels between daughters according to the fracture status of their mother.

Sponsors and collaborators

Lead sponsor

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

Other Gov

Registry information

Official study title

Rôle de la Microarchitecture Osseuse Dans le déterminisme héréditaire de la fragilité Osseuse

Acronym: MODAM

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 10, 2010
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.