Norwegian Capture the Fracture Initiative

Hip Fracture Clinical Trial

— NoFRACT  

Official title:

Norwegian Capture the Fracture Initiative

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02536898
• Other study ID #: 2015/334
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures
• Osteoporotic Fractures
• Other Low-trauma Fracture
• Spinal Fractures
• Vertebral Fracture

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