Clinical trial NCT04151732: Factors Associated With Future Fractures in Middle-aged Men and Women
Official title: Factors Associated With Future Fractures in Middle-aged Men and Women. A Prospective Cohort Study From Malmö Dietary Cancer Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fractures, Bone
Fragility
Life Style
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Region Skane
First posted: 2019-11-05
Enrollment: 30351
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30,351

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Invited population based cohort from 1990's

Exclusion Criteria:

* None

Primary outcomes:
measure: Any fracture
timeFrame: 1992 - 2017
Secondary outcomes:
measure: Multiple fractures
timeFrame: 1992 - 2017
measure: Death
timeFrame: 1992 - 2017
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Lund University / Skane university hospital
Study officials:
References:
citation: 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.
citation: Rogmark 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.