Hip FractureNoFRACTNCT02536898
Norwegian Capture the Fracture Initiative
A study testing Fracture Liaison Service and Current treatment in people with Hip Fracture and Vertebral Fracture, run by Oslo University Hospital at 7 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hip Fracture, Vertebral Fracture, Other Low-trauma Fracture
- What is being tested?
- Fracture Liaison Service and Current treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94,260 participants
- Where
- 7 sitesNorway
- Study dates
- May 2015to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Low-energy fracture
Who cannot join
- finger fracture, toe fracture, face fracture, skull fracture
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Norway7 sites
Haukeland University Hospital
Bergen
Drammen Hospital
Drammen
Molde Hospital
Molde
Oslo University Hospital
Oslo
Bærum Hospital
Sandvika
University Hospital of North Norway
Tromsø
St. Olavs University Hospital
Trondheim
About this study
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.
Read the 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.
- Conditions
- Hip Fracture, Vertebral Fracture, Other Low-trauma Fracture
- Being tested
- Fracture Liaison Service, Current treatment
- Medical subject headings
- Hip Fractures, Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fracture Liaison ServiceOther
Current treatmentOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Fracture Liaison Service |
| Current treatment | Other | Treatment as offered before intervention. Receives: Other: Current treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fragility fracture
Incidence of fragility fractures per 10,000 person-years (distal forearm fractures, proximal humerus fractures and hip fractures)
Measured: 4 years
Secondary outcomes (1)
Mortality
Total number of deaths during four years after enrollment
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2020
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 94,260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Lene Bergendal Solberg, Oslo University Hospital
- Investigators
- Lars Nordsletten, PhD, Study director, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536898
- Sponsor's protocol ID
- 2015/334
- Acronym
- NoFRACT
- Status last verified
- Mar 2022
- First submitted
- 30 Apr 2015
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30646281
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norwegian Capture the Fracture Initiative
- ClinicalTrials.gov ID
- NCT02536898
- Acronym / sponsor ID
- NoFRACT / 2015/334
- Conditions
- Hip Fracture, Vertebral Fracture, Other Low-trauma Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94,260 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- 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
- Study start
- May 2015
- Primary completion
- Jan 2020 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 1 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fracture liaison service | Experimental | Other: 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 |
| Current treatment | Other | Other: Current treatmentTreatment as offered before intervention. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Low-energy fracture
Key exclusion criteria (1 listed)
- finger fracture, toe fracture, face fracture, skull fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fracture Liaison Service | Other | Fracture liaison service |
| Current treatment | Other | Current treatment |
Primary outcome
Fragility fracture
Time frame: 4 years
Incidence of fragility fractures per 10,000 person-years (distal forearm fractures, proximal humerus fractures and hip fractures)
1 secondary outcome
Mortality
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Derived from this study: PubMed 30646281Andreasen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Nordsletten, PhD study director
Oslo University Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fracture Liaison Service and Current treatment in people with Hip Fracture and Vertebral Fracture, run by Oslo University Hospital at 7 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fragility fracture (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02536898, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.