Back to resultsNorwegian Capture the Fracture Initiative (NoFRACT)
Primary Purpose
Hip Fracture, Vertebral Fracture, Other Low-trauma Fracture
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Fracture Liaison Service
Current treatment
Sponsored by
About this trial
This is an interventional prevention trial for Hip Fracture
Eligibility Criteria
Inclusion Criteria:
- Low-energy fracture
Exclusion Criteria:
- finger fracture, toe fracture, face fracture, skull fracture
Sites / Locations
- Haukeland University Hospital
- Drammen Hospital
- Molde Hospital
- Oslo University Hospital
- Bærum Hospital
- University Hospital of North Norway
- St. Olavs University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Fracture liaison service
Current treatment
Arm Description
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
Treatment as offered before intervention.
Outcomes
Primary Outcome Measures
Fragility fracture
Incidence of fragility fractures per 10,000 person-years (distal forearm fractures, proximal humerus fractures and hip fractures)
Secondary Outcome Measures
Mortality
Total number of deaths during four years after enrollment
Full Information
NCT ID
NCT02536898
First Posted
April 30, 2015
Last Updated
March 21, 2022
Sponsor
Oslo University Hospital
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
1. Study Identification
Unique Protocol Identification Number
NCT02536898
Brief Title
Norwegian Capture the Fracture Initiative
Acronym
NoFRACT
Official Title
Norwegian Capture the Fracture Initiative
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
January 2020 (Actual)
Study Completion Date
May 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
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
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture, Vertebral Fracture, Other Low-trauma Fracture
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94260 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fracture liaison service
Arm Type
Experimental
Arm Description
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
Arm Title
Current treatment
Arm Type
Other
Arm Description
Treatment as offered before intervention.
Intervention Type
Other
Intervention Name(s)
Fracture Liaison Service
Intervention Type
Other
Intervention Name(s)
Current treatment
Primary Outcome Measure Information:
Title
Fragility fracture
Description
Incidence of fragility fractures per 10,000 person-years (distal forearm fractures, proximal humerus fractures and hip fractures)
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Mortality
Description
Total number of deaths during four years after enrollment
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Low-energy fracture
Exclusion Criteria:
finger fracture, toe fracture, face fracture, skull fracture
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Nordsletten, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
Country
Norway
Facility Name
Drammen Hospital
City
Drammen
Country
Norway
Facility Name
Molde Hospital
City
Molde
Country
Norway
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway
Facility Name
Bærum Hospital
City
Sandvika
Country
Norway
Facility Name
University Hospital of North Norway
City
Tromsø
Country
Norway
Facility Name
St. Olavs University Hospital
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
30646281
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.
Results Reference
derived
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Norwegian Capture the Fracture Initiative
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