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Completed

NCT Number: NCT02536898

Norwegian Capture the Fracture Initiative

The main aim is to assess the effectiveness of introducing a standardized intervention program for treatment of patients with a fragility fracture as measured by changes in the fracture rates and the mortality.

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Key information

Conditions

Hip Fracture Back Injuries Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Other Low-trauma Fracture Spinal Fractures Spinal Injuries Vertebral Fracture Wounds and Injuries

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital, Bergen, Norway

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About this study

A fracture liaison service model of care is widely recommended but data on its effectiveness regarding reduced risk of recurrent fracture and fracture related mortality are scarce. The investigators therefore aim to assess the risk of subsequent fractures and mortality after a clinical fracture in patients who present to hospitals with a standardized intervention program. Seven Norwegian hospitals will be Stepped Wedge Cluster Randomized to a standardized intervention program with startup date between May 2015 and Jan 2016. The intervention will last throughout 2018 with follow-up throughout 2019. Outcomes before and after the intervention will be compared and each hospital will act as its own control. The effect of the intervention will be measured by using national patient registries on fractures and mortality.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Low-energy fracture

Exclusion criteria

  • finger fracture, toe fracture, face fracture, skull fracture

Treatment and study plan

Fracture Liaison Service

Other

current treatment

Other

Primary outcomes

  1. Fragility fracture

    Time frame: 4 years

    Incidence of fragility fractures per 10,000 person-years (distal forearm fractures, proximal humerus fractures and hip fractures)

Secondary outcomes

  1. Mortality

    Time frame: 4 years

    Total number of deaths during four years after enrollment

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Asker & Baerum Hospital
  • Drammen sykehus
  • Haukeland University Hospital
  • Molde Hospital
  • Norwegian University of Science and Technology
  • St. Olavs Hospital
  • University Hospital of North Norway
  • University of Oslo

Registry information

Acronym: NoFRACT

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Sep 1, 2015
Registry last updated
Mar 22, 2022

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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