Mother Daughter Bone Microarchitecture

Bone Fragility Clinical Trial

— MODAM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01258036
• Other study ID #: C09-37
• Secondary ID: 2009-A01295-52
• Status: Recruiting
• Phase: N/A
• First received: March 18, 2010
• Last updated: September 27, 2012
• Start date: March 2010
• Est. completion date: March 2013

Study information

• Verified date: January 2012
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Elisabeth Sornay-Rendu, MD
• Phone: 33 4 72 11 74 44
• Email: elisabeth.rendu[@]inserm.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Institutional Ethical Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1040
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Bone Fragility

Intervention

Radiation:
• HRpQCT
High Resolution peripheral Quantitative Computerized tomography

Biological:
• Sampling
Urine and blood samples

Radiation:
• Bone absorptiometry
DXA at the lumbar spine, hip, radius and whole body

Locations

Country	Name	City	State
France	Unité Inserm 831, Pavillon F, Hôpital Edouard Herriot	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Role of bone microarchitecture in the hereditary determinism of bone fragility	Comparison of bone microarchitecture parameters from high resolution peripheral quantitative computer tomography (HRpQCT)between daughters according to the fracture status of their mother.	18 months	Yes
Secondary	Role of Bone mineral density in the hereditary determinism of bone fragility	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.	18 months	Yes
Secondary	Role of bone turnover and hormones in the hereditary determinism of bone fragility	Comparison of Bone markers and hormone levels between daughters according to the fracture status of their mother.	24 months	Yes