Osteoporotic FracturesNOFRACTsubNCT02608801
Prediction and Secondary Prevention of Fractures
An observational study of Osteoporotic Fractures and Hip Fractures, run by Oslo University Hospital at 6 sites in Norway.
Trial summary
The purpose of this study is to investigate patient related factors that contribute to increased risk of recurrent fractures and to investigate patient adherence to prescribed anti-osteoporotic drugs. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporotic Fractures, Hip Fractures, Wrist Fractures
- How many people
- 840 participants
- Where
- 6 sitesNorway
- Study dates
- Apr 2015to 31 Dec 2019
- Phase
- Observational
- 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
Study population: Patients already enrolled in NoFRACT main-study. Some patients will be asked to participate in this consent based sub-study, and must be able to answer questionairies, undergo DXA scan and bloodtests at baseline and follow-up.
Who may be able to join
- Patients participating in NoFRACT
- Recent low-trauma vertebral or non-vertebral fracture
- Written patient consent
Who cannot join
- Fractures of scull, face, toes or fingers
- Short life expectancy
- Patients not competent or willing to give consent
- Patients having difficulties in answering questionairies, undergoing a DXA scan, and show up on the follow-ups,
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Norway6 sites
Drammen hospital
Drammen
Molde Hospital
Molde
Orthopedic Center, Ulleval University Hospital
Oslo, 0408
Baerum Hospital
Sandvika, Gjettum
University Hospital of North Norway
Tromsø
St. Olavs Hospital
Trondheim, Trønderlag
About this study
Official title: Prediction and Secondary Preventing of Fractures in a Norwegian Population. A Substudy of Norwegian Capture the Fracture Initiative
The purpose of this study is to investigate patient related factors that contribute to increased risk of recurrent fractures and to investigate patient adherence to prescribed anti-osteoporotic drugs.
Read the detailed description
A standardized treatment program of osteoporosis will be introduced successively at 7 hospitals in Norway from April 2015 to January 2016. This Project is named NoFRACT (Norwegian Capture the Fracture Initiative https://clinicaltrials.gov/show/NCT02536898). Patients above 50 years of age, who recently have suffered a fragility fracture, will be offered examination of osteoporosis and treatment if indicated. Some of these patients will be asked to participate in this consent-based sub-study (NoFRACTsub). At baseline, the patients will be asked to answer a questionnaire, collect blood-sample for to outline possible causes for osteoporosis, in addition to Dual X-Ray Apsopiometry (DXA) scan including bone mineral density(BMD), trabecular bone score(TBS) and vertebral fracture assessment (VFA). At 1-year follow-up there will be a brief questionnaire and measuring of BTM. At 2-year follow-up there will be a brief questionnaire in addition to repeated measurement of DXA including BMD, TBS and VFA. All data will be stored securly at the designated server at the University of Oslo, Service of sensitive data, TSD.
- Conditions
- Osteoporotic Fractures, Hip Fractures, Wrist Fractures, Ankle Fractures, Vertebral Compression Fractures, Humeral Fractures, Proximal
- Medical subject headings
- Osteoporotic Fractures, Hip Fractures, Wrist Fractures, Ankle Fractures, Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients from NoFRACT | Patients from NoFRACT who consent to participate in this sub-study, will be offered examination and treatment with anti-osteoporotic drugs cf. treatment algorithm in the main-study. I.e. if osteoporosis is present clinically or at DXA scan, treatment is started. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fragility fractures
Number of new fractures during observation periode
Measured: 2 years
Secondary outcomes (8)
Bone mineral Density (BMD)
BMD in g/cm2 measured by DXA at both hips and lumbar spine. We want to study if there is a correlation between BMD an incidence of new fractures
Measured: Baseline, 2 years
Trabecular Bone Score (TBS)
TBS is an absolute value calculated from the DXA scans of L1-L4. We want to see if TBS can be used as a predictor of future fractures
Measured: Baseline, 2 years
Spinal Deformity Index (SDI)
Grading of vertebral fractures (SQ1=1 point, SQ2 =2 points, SQ3= 3 points) by Vertebral Fracture Assessment of lateral DXA scans. The total of points is the SDI. We want to see if there is a correlation between present fractures at baseline and future fractures
Measured: Baseline, 2 years
s-CTX
Fasting CTX (carboxy-terminal collagen crosslinks)in serum, measured in pg/ml
Measured: At 1 year follow-up
s-PINP
Fasting PINP (Procollagen I Intact N-Terminal)in Serum, measured in mcg/L
Measured: At 1 year follow-up
FRAX score
Calculation 10-year fracture risk for major osteoporotic and hip fractures by FRAX calculated during DXA scanning, on a population treated with AOD
Measured: Baseline
Garvan score
Calculation of 10-year fracture risk for major osteoporotic and hip fracture using online available Garvan Nomogram, on a population treated with AOD.
Measured: Baseline
Self-reported adherence to anti-osteoporotic drugs (AOD)
Self-reported use of AOD by questionnaire. Answer yes or no. If terminating of the treatment, patients will be asked to describe why.
Measured: Baseline, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startApr 2015
- Primary completion31 Dec 2017
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporotic FracturesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 840 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, Norwegian University of Science and Technology, St. Olavs Hospital, University Hospital of North Norway, University of Oslo
- Responsible party
- Principal investigator, Frede Frihagen, Oslo University Hospital
- Investigators
- Åshild Bjørnerem, Dr Med, Study director, The Arctic University of Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608801
- Sponsor's protocol ID
- 2014/2260REK OS
- Acronym
- NOFRACTsub
- Status last verified
- Mar 2020
- First submitted
- 17 Nov 2015
- Last updated
- 4 Mar 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction and Secondary Preventing of Fractures in a Norwegian Population. A Substudy of Norwegian Capture the Fracture Initiative
- ClinicalTrials.gov ID
- NCT02608801
- Acronym / sponsor ID
- NOFRACTsub / 2014/2260REK OS
- Conditions
- Osteoporotic Fractures, Hip Fractures, Wrist Fractures, Ankle Fractures, Vertebral Compression Fractures, Humeral Fractures, Proximal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 840 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Asker & Baerum Hospital, Drammen sykehus, Haukeland University Hospital, Molde Hospital, Norwegian University of Science and Technology, St. Olavs Hospital, University Hospital of North Norway, University of Oslo
- Study start
- Apr 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 20 Nov 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 purpose of this study is to investigate patient related factors that contribute to increased risk of recurrent fractures and to investigate patient adherence to prescribed anti-osteoporotic drugs.
Detailed description
A standardized treatment program of osteoporosis will be introduced successively at 7 hospitals in Norway from April 2015 to January 2016. This Project is named NoFRACT (Norwegian Capture the Fracture Initiative https://clinicaltrials.gov/show/NCT02536898). Patients above 50 years of age, who recently have suffered a fragility fracture, will be offered examination of osteoporosis and treatment if indicated. Some of these patients will be asked to participate in this consent-based sub-study (NoFRACTsub). At baseline, the patients will be asked to answer a questionnaire, collect blood-sample for to outline possible causes for osteoporosis, in addition to Dual X-Ray Apsopiometry (DXA) scan including bone mineral density(BMD), trabecular bone score(TBS) and vertebral fracture assessment (VFA). At 1-year follow-up there will be a brief questionnaire and measuring of BTM. At 2-year follow-up there will be a brief questionnaire in addition to repeated measurement of DXA including BMD, TBS and VFA. All data will be stored securly at the designated server at the University of Oslo, Service of sensitive data, TSD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients from NoFRACT | – | –Patients from NoFRACT who consent to participate in this sub-study, will be offered examination and treatment with anti-osteoporotic drugs cf. treatment algorithm in the main-study. I.e. if osteoporosis is present clinically or at DXA scan, treatment is started. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients already enrolled in NoFRACT main-study. Some patients will be asked to participate in this consent based sub-study, and must be able to answer questionairies, undergo DXA scan and bloodtests at baseline and follow-up.
Key inclusion criteria (3 listed)
- Patients participating in NoFRACT
- Recent low-trauma vertebral or non-vertebral fracture
- Written patient consent
Key exclusion criteria (4 listed)
- Fractures of scull, face, toes or fingers
- Short life expectancy
- Patients not competent or willing to give consent
- Patients having difficulties in answering questionairies, undergoing a DXA scan, and show up on the follow-ups,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fragility fractures
Time frame: 2 years
Number of new fractures during observation periode
8 secondary outcomes
Bone mineral Density (BMD)
Time frame: Baseline, 2 years
Trabecular Bone Score (TBS)
Time frame: Baseline, 2 years
Spinal Deformity Index (SDI)
Time frame: Baseline, 2 years
s-CTX
Time frame: At 1 year follow-up
s-PINP
Time frame: At 1 year follow-up
FRAX score
Time frame: Baseline
Garvan score
Time frame: Baseline
Self-reported adherence to anti-osteoporotic drugs (AOD)
Time frame: Baseline, 1 year, 2 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 4 Mar 2020.
- NoFRACTLink provided by the sponsor.
Related trials for Osteoporotic Fractures
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis
Active, not recruitingObservational study
Quebec Registry for Atypical Femur Fractures
Atypical Femur Fracture
Not yet recruitingObservational study
Functional Outcomes in Older Adults With Fragility Fractures of the Pelvis: The FFP-France Study
Fragility Fractures of the Pelvis (FFP), Osteoporotic Fractures
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.
Åshild Bjørnerem, Dr Med study director
The Arctic University of Norway
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporotic Fractures and Hip Fractures, run by Oslo University Hospital at 6 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 3 inclusion and 4 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 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 fractures (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2020.