Norwegian Capture the Fracture Initiative
NoFRACT
1 other identifier
interventional
94,260
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2015
Longer than P75 for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedFirst Posted
Study publicly available on registry
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedMarch 22, 2022
March 1, 2022
4.7 years
April 30, 2015
March 21, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Fragility fracture
Incidence of fragility fractures per 10,000 person-years (distal forearm fractures, proximal humerus fractures and hip fractures)
4 years
Secondary Outcomes (1)
Mortality
4 years
Study Arms (2)
Fracture liaison service
EXPERIMENTAL* 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
Current treatment
OTHERTreatment as offered before intervention.
Interventions
Eligibility Criteria
You may qualify if:
- Low-energy fracture
You may not qualify if:
- finger fracture, toe fracture, face fracture, skull fracture
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oslo University Hospitallead
- Asker & Baerum Hospitalcollaborator
- Drammen sykehuscollaborator
- Haukeland University Hospitalcollaborator
- Molde Hospitalcollaborator
- St. Olavs Hospitalcollaborator
- University Hospital of North Norwaycollaborator
- University of Oslocollaborator
- Norwegian University of Science and Technologycollaborator
Study Sites (7)
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
Related Publications (1)
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.
PMID: 30646281DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lars Nordsletten, PhD
Oslo University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. Med.
Study Record Dates
First Submitted
April 30, 2015
First Posted
September 1, 2015
Study Start
May 1, 2015
Primary Completion
January 1, 2020
Study Completion
May 1, 2020
Last Updated
March 22, 2022
Record last verified: 2022-03