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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02536898
Other study ID # 2015/334
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2015
Est. completion date May 2020

Study information

Verified date March 2022
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 94260
Est. completion date May 2020
Est. primary completion date January 2020
Accepts healthy volunteers No
Gender All
Age group 50 Years and older
Eligibility Inclusion Criteria: - Low-energy fracture Exclusion Criteria: - finger fracture, toe fracture, face fracture, skull fracture

Study Design


Intervention

Other:
Fracture Liaison Service

Current treatment


Locations

Country Name City State
Norway Haukeland University Hospital Bergen
Norway Drammen Hospital Drammen
Norway Molde Hospital Molde
Norway Oslo University Hospital Oslo
Norway Bærum Hospital Sandvika
Norway University Hospital of North Norway Tromsø
Norway St. Olavs University Hospital Trondheim

Sponsors (9)

Lead Sponsor Collaborator
Oslo University Hospital 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

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fragility fracture Incidence of fragility fractures per 10,000 person-years (distal forearm fractures, proximal humerus fractures and hip fractures) 4 years
Secondary Mortality Total number of deaths during four years after enrollment 4 years
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