Prediction and Secondary Prevention of Fractures
NOFRACTsub
1 other identifier
observational
840
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2015
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 17, 2015
CompletedFirst Posted
Study publicly available on registry
November 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedMarch 4, 2020
March 1, 2020
2.8 years
November 17, 2015
March 3, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Fragility fractures
Number of new fractures during observation periode
2 years
Secondary Outcomes (8)
Bone mineral Density (BMD)
Baseline, 2 years
Trabecular Bone Score (TBS)
Baseline, 2 years
Spinal Deformity Index (SDI)
Baseline, 2 years
s-CTX
At 1 year follow-up
s-PINP
At 1 year follow-up
- +3 more secondary outcomes
Study Arms (1)
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.
Eligibility Criteria
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.
You may qualify if:
- Patients participating in NoFRACT
- Recent low-trauma vertebral or non-vertebral fracture
- Written patient consent
You may not qualify if:
- 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,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oslo University Hospitallead
- Asker & Baerum Hospitalcollaborator
- Drammen sykehuscollaborator
- Haukeland University Hospitalcollaborator
- Molde Hospitalcollaborator
- Norwegian University of Science and Technologycollaborator
- St. Olavs Hospitalcollaborator
- University Hospital of North Norwaycollaborator
- University of Oslocollaborator
Study Sites (6)
Baerum Hospital
Sandvika, Gjettum, Norway
St. Olavs Hospital
Trondheim, Trønderlag, Norway
Drammen hospital
Drammen, Norway
Molde Hospital
Molde, Norway
Orthopedic Center, Ulleval University Hospital
Oslo, 0408, Norway
University Hospital of North Norway
Tromsø, Norway
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Åshild Bjørnerem, Dr Med
The Arctic University of Norway
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant
Study Record Dates
First Submitted
November 17, 2015
First Posted
November 20, 2015
Study Start
April 1, 2015
Primary Completion
December 31, 2017
Study Completion
December 31, 2019
Last Updated
March 4, 2020
Record last verified: 2020-03