Clinical trial NCT01258036: Mother Daughter Bone Microarchitecture
Official title: Rôle De La Microarchitecture Osseuse Dans Le Déterminisme Héréditaire De La Fragilité Osseuse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Fragility
Keywords: Bone microarchitecture
Bone mineral density
Bone markers
hereditary determinism
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2010-12-10
Enrollment: 1040
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 1. Fractured mothers and their daughters (case group)
2. Non-fractured mothers and their daughters (control group)

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Role of bone microarchitecture in the hereditary determinism of bone fragility
timeFrame: 18 months
Secondary outcomes:
measure: Role of Bone mineral density in the hereditary determinism of bone fragility
timeFrame: 18 months
measure: Role of bone turnover and hormones in the hereditary determinism of bone fragility
timeFrame: 24 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Unité Inserm 831, Pavillon F, Hôpital Edouard Herriot
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Elisabeth Sornay-Rendu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Roland D Chapurlat, MD PHD
role: STUDY_DIRECTOR
References: