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NCT02536898·Not applicable·INTERVENTIONAL

Norwegian Capture the Fracture Initiative

TeriparatideOtherCompleted

Status

Completed

Phase

Not applicable

Enrollment

94,260

Locations

7

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

OTHER

Fracture Liaison Service

OTHER

Current treatment

Timeline

From registration to results.

  1. First posted

    Sep 1, 2015

  2. Study start

    May 2015

  3. Primary completion

    Jan 2020

  4. Study completion

    May 2020

  5. Results posted

    Not reported

  6. Registry updated

    Mar 22, 2022

Outcomes

What the study measures.

Primary outcomes

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

Mortality

Time frame · 4 years

Total number of deaths during four years after enrollment

Eligibility

Who can take part.

Minimum age
50 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Low-energy fracture Exclusion Criteria: * finger fracture, toe fracture, face fracture, skull fracture

Study locations

7 registered sites.

Norway. Showing up to 24 locations stored in the fast local snapshot.

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, Norway

Publications

Results and literature.

PMID 30646281 ↗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.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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