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NCT Number: NCT04151732

Factors Associated With Future Fractures in Middle-aged Men and Women

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Lund University / Skane university hospital

Malmö, 20501, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Invited population based cohort from 1990's

Exclusion criteria

  • None

Treatment and study plan

Physical activity, alcohol, tobacco

Behavioral

Physical activity, alcohol, tobacco - selfreported in the 1990's

Hormonal factors

Other

Hormonal factors - selfreported in the 1990's

Cardiovascular disease

Other

Cardiovascular disease - selfreported in the 1990's

Anthropometric measures

Other

Height, length, BMI

Primary outcomes

  1. 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)

Secondary outcomes

  1. Multiple fractures

    Time frame: 1992 - 2017

    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)

  2. Death

    Time frame: 1992 - 2017

    Number of patients who died during follow-up

Sponsors and collaborators

Lead sponsor

Lund University

Other

Collaborators

  • Region Skane

Registry information

Official study title

Factors Associated With Future Fractures in Middle-aged Men and Women. A Prospective Cohort Study From Malmö Dietary Cancer Cohort

Acronym: MDCFract

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 5, 2019
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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