NCT04151732

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30,351

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 6, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 5, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

1.6 years

First QC Date

October 24, 2019

Last Update Submit

October 7, 2020

Conditions

Fractures, BoneFragilityLife Style

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Multiple fractures

    1992 - 2017

  • Death

    1992 - 2017

Interventions

Physical activity, alcohol, tobaccoBEHAVIORAL

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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

30,351

You may qualify if:

  • Invited population based cohort from 1990's

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lund University / Skane university hospital

Malmo, 20501, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 35974320DERIVED

  • 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.

    PMID: 33598954DERIVED

MeSH Terms

Conditions

Fractures, Bone

Interventions

ExerciseEthanolTobacco ProductsHeart Disease Risk Factors

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaAlcoholsOrganic ChemicalsSmoking DevicesManufactured MaterialsTechnology, Industry, and AgricultureRisk FactorsRiskProbabilityStatistics as TopicEpidemiologic MethodsInvestigative TechniquesCausalityEpidemiologic FactorsQuality of Health CareHealth Care Quality, Access, and EvaluationHealth Care Evaluation MechanismsPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2019

First Posted

November 5, 2019

Study Start

November 6, 2018

Primary Completion

June 1, 2020

Study Completion

June 30, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)