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

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.

Study Overview

• Status: Completed
• Conditions: Fractures, Bone; Life Style; Fragility
• Intervention / Treatment: Behavioral: Physical activity, alcohol, tobacco; Other: Hormonal factors; Other: Cardiovascular disease; Other: Anthropometric measures

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 Type: Observational
• Enrollment (Actual): 30351

Contacts and Locations

Study Locations

• Sweden
  • Malmö, Sweden, 20501
    • Lund University / Skane university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

30,351

Description

Inclusion Criteria:

• Invited population based cohort from 1990's

Exclusion Criteria:

• None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1992 - 2017

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	1992 - 2017
Death	Number of patients who died during follow-up	1992 - 2017

Collaborators and Investigators

• Sponsor: Lund University
• Collaborators: Region Skane

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2018
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: October 24, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 7, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: MDCFract1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No