NCT02861989

Brief Summary

Osteoporosis (OP) and subsequent fractures (OP fractures) are a source of morbidity and high mortality in the elderly. Despite numerous programs aiming at improving OP care, the prevention, diagnostic and treatment remain suboptimal. Barriers to a better care are multiple, both in the general and at-risk population, and in medical practitioners. Since they do not perceive their susceptibility to OP, people do not see the benefit of prevention. In addition, physicians do not give sufficient importance to OP prevention and care, despite the existence of guidelines. The investigators implemented a qualitative study to explore the knowledge and representations regarding osteoporosis in the general and at-risk population and in doctors in Rhône-Alpes Region, France, using focus groups with women and men and semi-structured face-to-face interviews with general practitioners. Understanding barriers to osteoporosis care in patients and general practitioners will help to set up effective strategies to improve prevention and treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 10, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

August 10, 2016

Status Verified

July 1, 2016

Enrollment Period

11 months

First QC Date

August 2, 2016

Last Update Submit

August 5, 2016

Conditions

Osteoporosis

Keywords

osteoporosispreventioncare managementfocus groups

Outcome Measures

Primary Outcomes (1)

  • Focus Group Interview

    Representations of osteoporosis, in general practitioners and in 4 groups of people. Representations were drawn from focus groups interviews based on the theory of social representations of illness developed by Moscovici and Durkheim. Four types of focus groups were conducted until data saturation: 9 groups with women aged 50 to 85 years and 7 groups with men aged 60 to 85 years, with or without a history of fragility fracture or an osteoporosis diagnostic. In parallel, semi-structured face-to face interviews were conducted with 16 general practitioners

    24 hours

Secondary Outcomes (2)

  • Factors favoring and barriers to a better management of OP in each group

    At the day of inclusion

  • Specific communication needs for the different groups: men/women, fractured/non-fractured.

    At the day of inclusion

Study Arms (5)

Osteoporotic women

women over 50 years with a diagnosis of osteoporosis or history of fragility fracture /osteoporosis treatment

Other: qualitative study

At risk women

women over 50 years without a diagnosis of osteoporosis or history of fragility fracture /osteoporosis treatment

Other: qualitative study

Osteoporotic men

Men over 60 years with a diagnosis of osteoporosis or history of fragility fracture /osteoporosis treatment

Other: qualitative study

At-risk men

Men over 60 years without a diagnosis of osteoporosis or history of fragility fracture /osteoporosis treatment

Other: qualitative study

General practitioners

General practitioners from the Rhône area, France

Other: qualitative study

Interventions

qualitative studyOTHER
At risk womenAt-risk menGeneral practitionersOsteoporotic menOsteoporotic women

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

women aged 50 to 85 years and men aged 60 to 85 years, and general practitioners.

You may qualify if:

  • group 1: women aged 50 to 85 years with a history of fragility fracture or an osteoporosis diagnostic
  • group 2: women aged 50 to 85 years without a history of fragility fracture or an osteoporosis diagnostic
  • group 3: men aged 60 to 85 years with a history of fragility fracture or an osteoporosis diagnostic
  • group 4: men aged 60 to 85 years without a history of fragility fracture or an osteoporosis diagnostic
  • group 5: general practitioners in Region Rhône-Alpes, France
  • who signed the consent form

You may not qualify if:

  • no signed consent
  • legal disability
  • difficulty in understanding French
  • psychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pôle IMER, Hospices Civils de Lyon

Lyon, 69424, France

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Anne-Marie Schott, Pr

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2016

First Posted

August 10, 2016

Study Start

February 1, 2014

Primary Completion

January 1, 2015

Study Completion

February 1, 2017

Last Updated

August 10, 2016

Record last verified: 2016-07

Locations

FR(1)