NCT01258036

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,040

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

May 4, 2010

Completed
7 months until next milestone

First Posted

Study publicly available on registry

December 10, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2012

Completed
Last Updated

November 18, 2025

Status Verified

January 1, 2025

Enrollment Period

1.8 years

First QC Date

March 18, 2010

Last Update Submit

November 14, 2025

Conditions

Bone Fragility

Keywords

Bone microarchitectureBone mineral densityBone markershereditary determinism

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Role of Bone mineral density in the hereditary determinism of bone fragility

    18 months

  • Role of bone turnover and hormones in the hereditary determinism of bone fragility

    24 months

Study Arms (2)

Fractured Mothers

Fractured Mothers and their daughters

Radiation: HRpQCTBiological: SamplingRadiation: Bone absorptiometry

Non fractured mothers

Mothers non fractured and their daughters

Radiation: HRpQCTBiological: SamplingRadiation: Bone absorptiometry

Interventions

HRpQCTRADIATION

High Resolution peripheral Quantitative Computerized tomography

Also known as: XTreme CT,Scanco Medical, Bassersdorf, Switzerland
Fractured MothersNon fractured mothers
SamplingBIOLOGICAL

Urine and blood samples

Also known as: Bone markers, hormones
Fractured MothersNon fractured mothers
Bone absorptiometryRADIATION

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

Also known as: Hologic, Waltham,MA, USA
Fractured MothersNon fractured mothers

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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).

You may not qualify if:

  • Adoptive daughters
  • Nonmenopausal mothers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unité Inserm 831, Pavillon F, Hôpital Edouard Herriot

Lyon, 69437, France

Location

Related Publications (1)

  • Nagy H, Sornay-Rendu E, Boutroy S, Vilayphiou N, Szulc P, Chapurlat R. Impaired trabecular and cortical microarchitecture in daughters of women with osteoporotic fracture: the MODAM study. Osteoporos Int. 2013 Jun;24(6):1881-9. doi: 10.1007/s00198-012-2223-3. Epub 2012 Nov 23.

    PMID: 23179577RESULT

Biospecimen

Retention: SAMPLES WITH DNA

serum plasma urine whole blood for DNA extraction

MeSH Terms

Interventions

Hormones

Intervention Hierarchy (Ancestors)

Hormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Elisabeth Sornay-Rendu, MD

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

    PRINCIPAL INVESTIGATOR

  • Roland D Chapurlat, MD PHD

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

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2010

First Posted

December 10, 2010

Study Start

May 4, 2010

Primary Completion

February 29, 2012

Study Completion

February 29, 2012

Last Updated

November 18, 2025

Record last verified: 2025-01

Locations

FR(1)