OsteoporosisMPCosteoporoseNCT03537846
Osteoporosis Awareness Survey of Women in Champagne Ardenne
An observational study of Osteoporosis, run by CHU de Reims at 1 site in France.
Trial summary
Osteoporosis is characterized by low bone mineral density and alterations in bone microarchitecture, leading to bone fragility and high risk of fractures. In the peri-menopausal period and during menopause, estrogen deficiency is responsible for an acceleration of bone remodeling. Read more about this study
- Who is it for?
- Ages 30 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- How many people
- 274 participants
- Where
- 1 siteFrance
- Study dates
- 19 Mar 2018to 30 Apr 2018
- 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 30 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: women
Who may be able to join
- gender : women
- age over thirty years old
Who cannot join
- Cognitive state incompatible with the collection of information
- women doctors
Trial locations and contacts
1 site in 1 country.
About this study
Osteoporosis is characterized by low bone mineral density and alterations in bone microarchitecture, leading to bone fragility and high risk of fractures. In the peri-menopausal period and during menopause, estrogen deficiency is responsible for an acceleration of bone remodeling. It is therefore important to sensitize women to this pathology at the beginning of menopause.
Osteoporosis is a public health issue with more than 3 million women in France suffering from almost ¼ of the population over 50 years old. Paradoxically, the number of bone densitometry and prescribed osteoporosis drugs are decreasing. There is an under-screening and a disinterest of the pathology on the part of the medical world and the patients.
Read more
The investigators hypothesize that women lack knowledge about osteoporosis. This study will identify these gaps, and put in place appropriate strategies to improve this knowledge.
For this purpose, a descriptive cross-sectional observational study will carry out, through the fulfillment of self-administered questionnaire for women over 30 years old. The main objective is to assess the knowledge of women, about osteoporosis and its consequences. The judgment criterion is based on a percentage of correct answers per question. The interests of the study are to identify gaps in knowledge, to optimize the investigator's therapeutic education, to fight patient wait-and-see and false beliefs, and finally to improve adherence and longer-term adherence.
Read the detailed description
This is a descriptive cross-sectional observational study, recruiting women over 30 years old, by the diffusion of the questionnaire in the general practices of Champagne-Ardenne, and the rheumatology department of CHU de Reims.
The main objective of the study is to assess the knowledge of women over 30 on osteoporosis and its consequences. The judgment criterion is a calculation of the percentage of correct answers per question. The investigation plan is based on a self-administered questionnaire survey .The statistical analysis plan is based on a descriptive analysis with sorting flat and sorted; The questionnaires will be disseminated from March 2018 to May 2018, with the valuation of results on June 1, 2018.
This questionnaire includes:
- 6 questions relating to the patient : risk of osteoporosis and specific management.
- 17 questions about osteoporosis knowledge
- 8 questions about information resources received on osteoporosis ( media, general practitioner …) The questionnaire will be accompanied by a cover letter and a consent form. The filling of the questionnaire should last between 5 and 7 minutes. The patient will then give back the questionnaire directly to the person who has offered him to fill it out (general practitioner, rheumatologist, nurse).
The questionnaires will be placed in waiting rooms of doctors, dentists, and paramedics of the Marne, the Ardennes, and the Aube.
- Conditions
- Osteoporosis
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Osteoporosis and women | Patient women over thirty years old |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive analysis with sorting flat and crossed sorting and calculation percentage
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start19 Mar 2018
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537846
- Sponsor's protocol ID
- PO18048
- Acronym
- MPCosteoporose
- Status last verified
- Jul 2018
- First submitted
- 15 May 2018
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteoporosis Awareness Survey of Women in Champagne Ardenne
- ClinicalTrials.gov ID
- NCT03537846
- Acronym / sponsor ID
- MPCosteoporose / PO18048
- Conditions
- Osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 25 May 2018 (actual)
- 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.
Osteoporosis is characterized by low bone mineral density and alterations in bone microarchitecture, leading to bone fragility and high risk of fractures. In the peri-menopausal period and during menopause, estrogen deficiency is responsible for an acceleration of bone remodeling. It is therefore important to sensitize women to this pathology at the beginning of menopause.
Osteoporosis is a public health issue with more than 3 million women in France suffering from almost ¼ of the population over 50 years old. Paradoxically, the number of bone densitometry and prescribed osteoporosis drugs are decreasing. There is an under-screening and a disinterest of the pathology on the part of the medical world and the patients.
The investigators hypothesize that women lack knowledge about osteoporosis. This study will identify these gaps, and put in place appropriate strategies to improve this knowledge.
For this purpose, a descriptive cross-sectional observational study will carry out, through the fulfillment of self-administered questionnaire for women over 30 years old. The main objective is to assess the knowledge of women, about osteoporosis and its consequences. The judgment criterion is based on a percentage of correct answers per question. The interests of the study are to identify gaps in knowledge, to optimize the investigator's therapeutic education, to fight patient wait-and-see and false beliefs, and finally to improve adherence and longer-term adherence.
Detailed description
This is a descriptive cross-sectional observational study, recruiting women over 30 years old, by the diffusion of the questionnaire in the general practices of Champagne-Ardenne, and the rheumatology department of CHU de Reims.
The main objective of the study is to assess the knowledge of women over 30 on osteoporosis and its consequences. The judgment criterion is a calculation of the percentage of correct answers per question. The investigation plan is based on a self-administered questionnaire survey .The statistical analysis plan is based on a descriptive analysis with sorting flat and sorted; The questionnaires will be disseminated from March 2018 to May 2018, with the valuation of results on June 1, 2018.
This questionnaire includes:
- 6 questions relating to the patient : risk of osteoporosis and specific management.
- 17 questions about osteoporosis knowledge
- 8 questions about information resources received on osteoporosis ( media, general practitioner …) The questionnaire will be accompanied by a cover letter and a consent form. The filling of the questionnaire should last between 5 and 7 minutes. The patient will then give back the questionnaire directly to the person who has offered him to fill it out (general practitioner, rheumatologist, nurse).
The questionnaires will be placed in waiting rooms of doctors, dentists, and paramedics of the Marne, the Ardennes, and the Aube.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osteoporosis and women | – | –Patient women over thirty years old |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- women
Key inclusion criteria (2 listed)
- gender : women
- age over thirty years old
Key exclusion criteria (2 listed)
- Cognitive state incompatible with the collection of information
- women doctors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Descriptive analysis with sorting flat and crossed sorting and calculation percentage
Time frame: Day 0
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 3 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Osteoporosis, run by CHU de Reims 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 2 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 3 Jul 2018. 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?
Descriptive analysis with sorting flat and crossed sorting and calculation percentage (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2018.