Clinical trial NCT02536898: Norwegian Capture the Fracture Initiative
Official title: Norwegian Capture the Fracture Initiative
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fracture
Vertebral Fracture
Other Low-trauma Fracture
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Asker & Baerum Hospital
name: Drammen sykehus
name: Haukeland University Hospital
name: Molde Hospital
name: St. Olavs Hospital
name: University Hospital of North Norway
name: University of Oslo
name: Norwegian University of Science and Technology
First posted: 2015-09-01
Enrollment: 94260
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Low-energy fracture

Exclusion Criteria:

* finger fracture, toe fracture, face fracture, skull fracture

Primary outcomes:
measure: Fragility fracture
timeFrame: 4 years
Secondary outcomes:
measure: Mortality
timeFrame: 4 years
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Drammen
country: Norway
facility: Drammen Hospital
city: Molde
country: Norway
facility: Molde Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Sandvika
country: Norway
facility: Bærum Hospital
city: Tromsø
country: Norway
facility: University Hospital of North Norway
city: Trondheim
country: Norway
facility: St. Olavs University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Lars Nordsletten, PhD
role: STUDY_DIRECTOR
References:
citation: Andreasen C, Solberg LB, Basso T, Borgen TT, Dahl C, Wisloff T, Hagen G, Apalset EM, Gjertsen JE, Figved W, Hubschle LM, Stutzer JM, Elvenes J, Joakimsen RM, Syversen U, Eriksen EF, Nordsletten L, Frihagen F, Omsland TK, Bjornerem A. Effect of a Fracture Liaison Service on the Rate of Subsequent Fracture Among Patients With a Fragility Fracture in the Norwegian Capture the Fracture Initiative (NoFRACT): A Trial Protocol. JAMA Netw Open. 2018 Dec 7;1(8):e185701. doi: 10.1001/jamanetworkopen.2018.5701.