Fractures, BoneMDCFractNCT04151732
Factors Associated With Future Fractures in Middle-aged Men and Women
An observational study of Fractures, Bone and Fragility, run by Lund University at 1 site in Sweden.
Trial summary
From prospectively collected health and life-style data and anthropometric data in the Malmo Diet and Cancer (MDC) cohort identify factors that predicts or are associated with forthcoming fracture in middle-aged men and women. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Fractures, Bone, Fragility, Life Style
- What is being tested?
- Physical activity, alcohol, tobacco, Hormonal factors and Cardiovascular disease
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30,351 participants
- Where
- 1 siteSweden
- Study dates
- 6 Nov 2018to 30 Jun 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 30,351
Who may be able to join
- Invited population based cohort from 1990's
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Factors Associated With Future Fractures in Middle-aged Men and Women. A Prospective Cohort Study From Malmö Dietary Cancer Cohort
From prospectively collected health and life-style data and anthropometric data in the Malmo Diet and Cancer (MDC) cohort identify factors that predicts or are associated with forthcoming fracture in middle-aged men and women.
Read the detailed description
In adults, the incidence of fractures increases with age. In predisposed individuals, even a minor trauma can result in a fracture. Such an injury is known as low-energy fracture or fragility fracture, and the risk increases with age. Fragility fractures may be preventable, either by changes in lifestyle or by medication of underlying diseases. Fragility fractures also put a burden both on the affected individual and on society. As the population age, more individuals are at risk, and the absolute numbers of fragility fractures increase. Therefore, identification of individuals at risk before fracture occurs would be ideal.In the prospectively collected Malmo Diet and Cancer (MDC) cohort a large number of health and life style variables have been gathered from randomly invited men and women in a city of 350,000 inhabitants in the 1990s'. The MDC database the investigators use for this study comprises 30,351 participants. Outcome is updated via crosslinking with the National Patient Register in Sweden.
MDC PhysFract - investigation of the following factors Socioeconomical factors: Level of education, employment status in middle age, physical activity / work load, living alone, stress, number of friends, feeling of loneliness.
Life style factors: Tobacco use, alcohol use. Summary of physical and psychological well-being.
MDC CardFract - investigation of the following factors Comorbidities: Hypertension, syncope/orthostatism, diabetes, coronary artery disease, atrial fibrillation, heart failure, ischemic stroke and others.
Pharmaceutical drugs associated with fracture risk. Cardiovascular blood tests.
MDC HormFract - investigation of the following factors Body composition: Weight at 20 yrs, weight change pattern, weight difference middle age minus 20 yrs.
Hormonal/gynecological status - women: Date for menarche and menopause, number of children, intake of oral contraceptives / hormonal replacement therapy, surgical menopause.
- Conditions
- Fractures, Bone, Fragility, Life Style
- Being tested
- Physical activity, alcohol, tobacco, Hormonal factors, Cardiovascular disease, Anthropometric measures
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity, alcohol, tobaccoBehavioural
Physical activity, alcohol, tobacco - selfreported in the 1990's
Hormonal factorsOther
Hormonal factors - selfreported in the 1990's
Cardiovascular diseaseOther
Cardiovascular disease - selfreported in the 1990's
Anthropometric measuresOther
Height, length, BMI
What is being measured
The primary outcome is the main question the study is designed to answer.
Any fracture
Number of patients who suffered any fracture during follow-up (ICD-10 codes S12.x, S22.x, S32.x, S42.x, S52.x, S62.x, S32.x, S72.x, M48.4, M84.3, and M96.6)
Measured: 1992 - 2017
Secondary outcomes (2)
Multiple fractures
Number of patients who suffered multiple fractures during follow-up (ICD-10 codes S12.x, S22.x, S32.x, S42.x, S52.x, S62.x, S32.x, S72.x, M48.4, M84.3, and M96.6)
Measured: 1992 - 2017
Death
Number of patients who died during follow-up
Measured: 1992 - 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start6 Nov 2018
- Primary completion1 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fractures, BoneStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe 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
- Prospective
- Enrolment
- 30,351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Skane
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151732
- Sponsor's protocol ID
- MDCFract1
- Acronym
- MDCFract
- Status last verified
- Oct 2020
- First submitted
- 24 Oct 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moberg L, Hamrefors V, Fedorowski A, Rogmark C. Early menopause and weight loss are significant factors associated with risk of future fracture in middle-aged women. BMC Musculoskelet Disord. 2022 Aug 16;23(1):779. doi: 10.1186/s12891-022-05744-5.
PubMed 35974320Rogmark C, Fedorowski A, Hamrefors V. Physical Activity and Psychosocial Factors Associated With Risk of Future Fractures in Middle-Aged Men and Women. J Bone Miner Res. 2021 May;36(5):852-860. doi: 10.1002/jbmr.4249. Epub 2021 Feb 18.
PubMed 33598954
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Future Fractures in Middle-aged Men and Women. A Prospective Cohort Study From Malmö Dietary Cancer Cohort
- ClinicalTrials.gov ID
- NCT04151732
- Acronym / sponsor ID
- MDCFract / MDCFract1
- Conditions
- Fractures, Bone, Fragility, Life Style
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30,351 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Region Skane
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 5 Nov 2019 (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.
From prospectively collected health and life-style data and anthropometric data in the Malmo Diet and Cancer (MDC) cohort identify factors that predicts or are associated with forthcoming fracture in middle-aged men and women.
Detailed description
In adults, the incidence of fractures increases with age. In predisposed individuals, even a minor trauma can result in a fracture. Such an injury is known as low-energy fracture or fragility fracture, and the risk increases with age. Fragility fractures may be preventable, either by changes in lifestyle or by medication of underlying diseases. Fragility fractures also put a burden both on the affected individual and on society. As the population age, more individuals are at risk, and the absolute numbers of fragility fractures increase. Therefore, identification of individuals at risk before fracture occurs would be ideal.In the prospectively collected Malmo Diet and Cancer (MDC) cohort a large number of health and life style variables have been gathered from randomly invited men and women in a city of 350,000 inhabitants in the 1990s'. The MDC database the investigators use for this study comprises 30,351 participants. Outcome is updated via crosslinking with the National Patient Register in Sweden.
MDC PhysFract - investigation of the following factors Socioeconomical factors: Level of education, employment status in middle age, physical activity / work load, living alone, stress, number of friends, feeling of loneliness.
Life style factors: Tobacco use, alcohol use. Summary of physical and psychological well-being.
MDC CardFract - investigation of the following factors Comorbidities: Hypertension, syncope/orthostatism, diabetes, coronary artery disease, atrial fibrillation, heart failure, ischemic stroke and others.
Pharmaceutical drugs associated with fracture risk. Cardiovascular blood tests.
MDC HormFract - investigation of the following factors Body composition: Weight at 20 yrs, weight change pattern, weight difference middle age minus 20 yrs.
Hormonal/gynecological status - women: Date for menarche and menopause, number of children, intake of oral contraceptives / hormonal replacement therapy, surgical menopause.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 30,351
Key inclusion criteria (1 listed)
- Invited population based cohort from 1990's
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Physical activity, alcohol, tobaccoPhysical activity, alcohol, tobacco - selfreported in the 1990's | Behavioural | – |
| Hormonal factorsHormonal factors - selfreported in the 1990's | Other | – |
| Cardiovascular diseaseCardiovascular disease - selfreported in the 1990's | Other | – |
| Anthropometric measuresHeight, length, BMI | Other | – |
Primary outcome
Any fracture
Time frame: 1992 - 2017
Number of patients who suffered any fracture during follow-up (ICD-10 codes S12.x, S22.x, S32.x, S42.x, S52.x, S62.x, S32.x, S72.x, M48.4, M84.3, and M96.6)
2 secondary outcomes
Multiple fractures
Time frame: 1992 - 2017
Death
Time frame: 1992 - 2017
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 8 Oct 2020.
- Derived from this study: PubMed 35974320Moberg L, Hamrefors V, Fedorowski A, Rogmark C. Early menopause and weight loss are significant factors associated with risk of future fracture in middle-aged women. BMC Musculoskelet Disord. 2022 Aug 16;23(1):779. doi: 10.1186/s12891-022-05744-5.
- Derived from this study: PubMed 33598954Rogmark C, Fedorowski A, Hamrefors V. Physical Activity and Psychosocial Factors Associated With Risk of Future Fractures in Middle-Aged Men and Women. J Bone Miner Res. 2021 May;36(5):852-860. doi: 10.1002/jbmr.4249. Epub 2021 Feb 18.
- Individual participant dataSharing planned: No
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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 Fractures, Bone and Fragility, run by Lund University at 1 site in Sweden.
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 1 inclusion and 1 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 8 Oct 2020. 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 Sweden. 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?
Any fracture (time frame: 1992 - 2017). 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 NCT04151732, which also lists 2 linked publications.
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 8 Oct 2020.