Prediction and Secondary Prevention of Fractures (NOFRACTsub)

March 3, 2020 updated by: Frede Frihagen, Oslo University Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
840

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Drammen, Norway
        • Drammen Hospital
      • Molde, Norway
        • Molde Hospital
      • Oslo, Norway, 0408
        • Orthopedic Center, Ulleval University Hospital
      • Tromsø, Norway
        • University Hospital of North Norway
    • Gjettum
      • Sandvika, Gjettum, Norway
        • Baerum hospital
    • Trønderlag
      • Trondheim, Trønderlag, Norway
        • St. Olavs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • Patients participating in NoFRACT
  • Recent low-trauma vertebral or non-vertebral fracture
  • Written patient consent

Exclusion Criteria:

  • 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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fragility fractures
Time Frame: 2 years
Number of new fractures during observation periode
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bone mineral Density (BMD)
Time Frame: Baseline, 2 years
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
Baseline, 2 years
Trabecular Bone Score (TBS)
Time Frame: Baseline, 2 years
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
Baseline, 2 years
Spinal Deformity Index (SDI)
Time Frame: Baseline, 2 years
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
Baseline, 2 years
s-CTX
Time Frame: At 1 year follow-up
Fasting CTX (carboxy-terminal collagen crosslinks)in serum, measured in pg/ml
At 1 year follow-up
s-PINP
Time Frame: At 1 year follow-up
Fasting PINP (Procollagen I Intact N-Terminal)in Serum, measured in mcg/L
At 1 year follow-up
FRAX score
Time Frame: Baseline
Calculation 10-year fracture risk for major osteoporotic and hip fractures by FRAX calculated during DXA scanning, on a population treated with AOD
Baseline
Garvan score
Time Frame: Baseline
Calculation of 10-year fracture risk for major osteoporotic and hip fracture using online available Garvan Nomogram, on a population treated with AOD.
Baseline
Self-reported adherence to anti-osteoporotic drugs (AOD)
Time Frame: Baseline, 1 year, 2 years
Self-reported use of AOD by questionnaire. Answer yes or no. If terminating of the treatment, patients will be asked to describe why.
Baseline, 1 year, 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oslo University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Oslo
University Hospital of North Norway
Norwegian University of Science and Technology
Asker & Baerum Hospital
Haukeland University Hospital
St. Olavs Hospital
Molde Hospital
Drammen sykehus

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Åshild Bjørnerem, Dr Med, The Arctic University of Norway

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014/2260REK OS

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