Mother Daughter Bone Microarchitecture (MODAM)

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

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.

Study Overview

• Status: Unknown
• Conditions: Bone Fragility
• Intervention / Treatment: Radiation: HRpQCT; Biological: Sampling; Radiation: Bone absorptiometry

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.

• Study Type: Observational
• Enrollment (Anticipated): 1040

Contacts and Locations

• Study Contact: Name: Elisabeth Sornay-Rendu, MD; Phone Number: 33 4 72 11 74 44; Email: elisabeth.rendu@inserm.fr

Study Locations

• France
  • Lyon, France, 69437
    • Recruiting
    • Unité Inserm 831, Pavillon F, Hôpital Edouard Herriot
    • Contact: Elisabteh Sornay-Rendu, MD; Phone Number: +331 4 72 11 74 44; Email: elisabeth.rendu@inserm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

1. Fractured mothers and their daughters (case group)
2. Non-fractured mothers and their daughters (control group)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fractured Mothers; Fractured Mothers and their daughters	Radiation: HRpQCT; High Resolution peripheral Quantitative Computerized tomography; Other Names: XTreme CT,Scanco Medical, Bassersdorf, Switzerland; Biological: Sampling; Urine and blood samples; Other Names: Bone markers, hormones; Radiation: Bone absorptiometry; DXA at the lumbar spine, hip, radius and whole body; Other Names: Hologic, Waltham,MA, USA
Non fractured mothers; Mothers non fractured and their daughters	Radiation: HRpQCT; High Resolution peripheral Quantitative Computerized tomography; Other Names: XTreme CT,Scanco Medical, Bassersdorf, Switzerland; Biological: Sampling; Urine and blood samples; Other Names: Bone markers, hormones; Radiation: Bone absorptiometry; DXA at the lumbar spine, hip, radius and whole body; Other Names: Hologic, Waltham,MA, USA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Principal Investigator: Elisabeth Sornay-Rendu, MD, Institut National de la Santé Et de la Recherche Médicale, France; Study Director: Roland D Chapurlat, MD PHD, Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): March 1, 2013

Study Registration Dates

• First Submitted: March 18, 2010
• First Submitted That Met QC Criteria: December 9, 2010
• First Posted (Estimate): December 10, 2010

Study Record Updates

• Last Update Posted (Estimate): September 28, 2012
• Last Update Submitted That Met QC Criteria: September 27, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Bone mineral density; Bone markers; Bone microarchitecture; hereditary determinism
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones
• Other Study ID Numbers: C09-37; 2009-A01295-52 (Registry Identifier: IDRCB)