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

Fractures, Bone Clinical Trial

— MDCFract  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04151732
• Other study ID #: MDCFract1
• Status: Completed
• Start date: November 6, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: October 2020
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30351
• Est. completion date: June 30, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Invited population based cohort from 1990's

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Fractures, Bone
• Fragility
• Life Style

Intervention

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

Other:
• Hormonal factors
Hormonal factors - selfreported in the 1990's
• Cardiovascular disease
Cardiovascular disease - selfreported in the 1990's
• Anthropometric measures
Height, length, BMI

Locations

Country	Name	City	State
Sweden	Lund University / Skane university hospital	Malmö

Sponsors (2)

Lead Sponsor	Collaborator
Lund University	Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Death	Number of patients who died during follow-up	1992 - 2017