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Norwegian Capture the Fracture Initiative (NoFRACT)

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ClinicalTrials.gov Identifier: NCT02536898
Recruitment Status : Recruiting
First Posted : September 1, 2015
Last Update Posted : May 7, 2018
Sponsor:
Collaborators:
Asker & Baerum Hospital
Drammen sykehus
Haukeland University Hospital
Molde Hospital
St. Olavs Hospital
University Hospital of North Norway
University of Oslo
Norwegian University of Science and Technology
Information provided by (Responsible Party):
Lene Bergendal Solberg, Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Hip Fracture Vertebral Fracture Other Low-trauma Fracture Other: Fracture Liaison Service Other: Current treatment Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 87000 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Norwegian Capture the Fracture Initiative
Study Start Date : May 2015
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fracture liaison service
  • Information, assessment & lifestyle advice
  • refer to DXA scan, except patients with dementia, difficulties laying on the back or short life exp.
  • Blood samples
  • Sufficient intake of Vitamin D & calcium, combined with physical activity will be recommended with lifestyle advice (smoking & alcohol intake)
  • Patients With Hip, Vertebral or two or more low-trauma fractures are recommended treated with anti-osteoporosis drug
  • Other fractures, treatment recommended if FRAX score≥20% for major fracture & T-score≤-1.5
  • Fracture patients with reduced kidney function will be treated with anti-RANKL
  • Anti-osteoporosis drug prescribed by hospital physician
  • Follow-up phone call after 3 months and visit to talk with coordinating nurse after 1 year
  • Patients with spine or femoral neck T-scores≤-3.5, >2 severe vertebral fractures & those who suffer a second fracture while using anti-osteoporosis drug, will be referred for further examination and teriparatide treatment will be considered
Other: Fracture Liaison Service
Current treatment
Treatment as offered before intervention.
Other: Current treatment



Primary Outcome Measures :
  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 Outcome Measures :
  1. Mortality [ Time Frame: 4 years ]
    Total number of deaths during four years after enrollment



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Low-energy fracture

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536898


Contacts
Contact: Åshild Bjørnerem, PhD 77660608 ashild.bjornerem@uit.no

Locations
Norway
Haukeland University Hospital Recruiting
Bergen, Norway
Contact: Ellen M Apalset         
Drammen Hospital Recruiting
Drammen, Norway
Contact: Tove T Borgen         
Molde Hospital Recruiting
Molde, Norway
Contact: Jens M Stutzer         
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Lene B Solberg         
Bærum Hospital Recruiting
Sandvika, Norway
Contact: Ellen Langslet         
University Hospital of North Norway Recruiting
Tromsø, Norway
Contact: Åshild Bjørnerem         
St. Olavs University Hospital Recruiting
Trondheim, Norway
Contact: Trude Basso         
Sponsors and Collaborators
Oslo University Hospital
Asker & Baerum Hospital
Drammen sykehus
Haukeland University Hospital
Molde Hospital
St. Olavs Hospital
University Hospital of North Norway
University of Oslo
Norwegian University of Science and Technology
Investigators
Study Director: Lars Nordsletten, PhD Oslo University Hospital

Responsible Party: Lene Bergendal Solberg, Prof. Dr. Med., Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02536898     History of Changes
Other Study ID Numbers: 2015/334
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Spinal Fractures
Osteoporotic Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Spinal Injuries
Back Injuries