Mother Daughter Bone Microarchitecture (MODAM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01258036
First received: March 18, 2010
Last updated: September 27, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Bone Fragility
Radiation: HRpQCT
Biological: Sampling
Radiation: Bone absorptiometry

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Rôle de la Microarchitecture Osseuse Dans le déterminisme héréditaire de la fragilité Osseuse

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • Role of bone microarchitecture in the hereditary determinism of bone fragility [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    Comparison of bone microarchitecture parameters from high resolution peripheral quantitative computer tomography (HRpQCT)between daughters according to the fracture status of their mother.


Secondary Outcome Measures:
  • Role of Bone mineral density in the hereditary determinism of bone fragility [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    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.

  • Role of bone turnover and hormones in the hereditary determinism of bone fragility [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Comparison of Bone markers and hormone levels between daughters according to the fracture status of their mother.


Biospecimen Retention:   Samples With DNA

serum plasma urine whole blood for DNA extraction


Estimated Enrollment: 1040
Study Start Date: March 2010
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Fractured Mothers
Fractured Mothers and their daughters
Radiation: HRpQCT
High Resolution peripheral Quantitative Computerized tomography
Other Name: XTreme CT,Scanco Medical, Bassersdorf, Switzerland
Biological: Sampling
Urine and blood samples
Other Name: Bone markers, hormones
Radiation: Bone absorptiometry
DXA at the lumbar spine, hip, radius and whole body
Other Name: Hologic, Waltham,MA, USA
Non fractured mothers
Mothers non fractured and their daughters
Radiation: HRpQCT
High Resolution peripheral Quantitative Computerized tomography
Other Name: XTreme CT,Scanco Medical, Bassersdorf, Switzerland
Biological: Sampling
Urine and blood samples
Other Name: Bone markers, hormones
Radiation: Bone absorptiometry
DXA at the lumbar spine, hip, radius and whole body
Other Name: Hologic, Waltham,MA, USA

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
  1. Fractured mothers and their daughters (case group)
  2. Non-fractured mothers and their daughters (control group)
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01258036

Contacts
Contact: Elisabeth Sornay-Rendu, MD 33 4 72 11 74 44 elisabeth.rendu@inserm.fr

Locations
France
Unité Inserm 831, Pavillon F, Hôpital Edouard Herriot Recruiting
Lyon, France, 69437
Contact: Elisabteh Sornay-Rendu, MD    +331 4 72 11 74 44    elisabeth.rendu@inserm.fr   
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01258036     History of Changes
Other Study ID Numbers: C09-37, 2009-A01295-52
Study First Received: March 18, 2010
Last Updated: September 27, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Bone microarchitecture
Bone mineral density
Bone markers
hereditary determinism

ClinicalTrials.gov processed this record on April 15, 2014