Bone FragilityMODAMNCT01258036
Mother Daughter Bone Microarchitecture
An observational study of Bone Fragility, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Bone Fragility
- What is being tested?
- HRpQCT, Sampling and Bone absorptiometry
- Type of treatment
- Surgery or procedure
- How many people
- 1,040 participants
- Where
- 1 siteFrance
- Study dates
- 4 May 2010to 29 Feb 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 1. Fractured mothers and their daughters (case group) 2. Non-fractured mothers and their daughters (control group)
Who may be able to join
- 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).
Who cannot join
- Adoptive daughters
- Nonmenopausal mothers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Bone Fragility
- Being tested
- HRpQCT, Sampling, Bone absorptiometry
- Keywords
- Bone microarchitecture, Bone mineral density, Bone markers, hereditary determinism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRpQCTRadiation
Also called XTreme CT,Scanco Medical, Bassersdorf, Switzerland
High Resolution peripheral Quantitative Computerized tomography
SamplingBiological
Also called Bone markers, hormones
Urine and blood samples
Bone absorptiometryRadiation
Also called Hologic, Waltham,MA, USA
DXA at the lumbar spine, hip, radius and whole body
| Study group | Role | What they receive |
|---|---|---|
| Fractured Mothers | Fractured Mothers and their daughters Receives: Radiation: HRpQCT; Biological: Sampling; Radiation: Bone absorptiometry | |
| Non fractured mothers | Mothers non fractured and their daughters Receives: Radiation: HRpQCT; Biological: Sampling; Radiation: Bone absorptiometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2010 (estimated)
- Study start4 May 2010
- Primary completion29 Feb 2012
- Study completion29 Feb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone FragilityStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,040 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Elisabeth Sornay-Rendu, MD, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, FranceRoland D Chapurlat, MD PHD, Study director, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01258036
- Sponsor's protocol ID
- C09-37
- Other IDs
- 2009-A01295-52
- Acronym
- MODAM
- Status last verified
- Jan 2025
- First submitted
- 18 Mar 2010
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23179577
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rôle de la Microarchitecture Osseuse Dans le déterminisme héréditaire de la fragilité Osseuse
- ClinicalTrials.gov ID
- NCT01258036
- Acronym / sponsor ID
- MODAM / C09-37
- Conditions
- Bone Fragility
- Keywords
- Bone microarchitecture, Bone mineral density, Bone markers, hereditary determinism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,040 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 4 May 2010 (actual)
- Primary completion
- 29 Feb 2012 (actual)
- Study completion
- 29 Feb 2012 (actual)
- First posted
- 10 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fractured Mothers | – | Radiation: HRpQCT, Biological: Sampling, Radiation: Bone absorptiometryFractured Mothers and their daughters |
| Non fractured mothers | – | Radiation: HRpQCT, Biological: Sampling, Radiation: Bone absorptiometryMothers non fractured and their daughters |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Fractured mothers and their daughters (case group) 2. Non-fractured mothers and their daughters (control group)
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (2 listed)
- Adoptive daughters
- Nonmenopausal mothers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRpQCTAlso: XTreme CT,Scanco Medical, Bassersdorf, SwitzerlandHigh Resolution peripheral Quantitative Computerized tomography | Radiation | Fractured Mothers, Non fractured mothers |
| SamplingAlso: Bone markers, hormonesUrine and blood samples | Biological | Fractured Mothers, Non fractured mothers |
| Bone absorptiometryAlso: Hologic, Waltham,MA, USADXA at the lumbar spine, hip, radius and whole body | Radiation | Fractured Mothers, Non fractured mothers |
Primary outcome
Role of bone microarchitecture in the hereditary determinism of bone fragility
Time frame: 18 months
Comparison of bone microarchitecture parameters from high resolution peripheral quantitative computer tomography (HRpQCT)between daughters according to the fracture status of their mother.
2 secondary outcomes
Role of Bone mineral density in the hereditary determinism of bone fragility
Time frame: 18 months
Role of bone turnover and hormones in the hereditary determinism of bone fragility
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Results publication: PubMed 23179577Nagy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Sornay-Rendu, MD principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
Roland D Chapurlat, MD PHD study director
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Fragility, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Role of bone microarchitecture in the hereditary determinism of bone fragility (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01258036, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.