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Prediction and Secondary Prevention of Fractures (NOFRACTsub)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02608801
Recruitment Status : Completed
First Posted : November 20, 2015
Last Update Posted : March 4, 2020
Sponsor:
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
Information provided by (Responsible Party):
Frede Frihagen, Oslo University Hospital

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.

Condition or disease
Osteoporotic Fractures Hip Fractures Wrist Fractures Ankle Fractures Vertebral Compression Fractures Humeral Fractures, Proximal

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.

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Study Type : Observational
Actual Enrollment : 840 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prediction and Secondary Preventing of Fractures in a Norwegian Population. A Substudy of Norwegian Capture the Fracture Initiative
Actual Study Start Date : April 2015
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Group/Cohort
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.



Primary Outcome Measures :
  1. Fragility fractures [ Time Frame: 2 years ]
    Number of new fractures during observation periode


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. s-CTX [ Time Frame: At 1 year follow-up ]
    Fasting CTX (carboxy-terminal collagen crosslinks)in serum, measured in pg/ml

  5. s-PINP [ Time Frame: At 1 year follow-up ]
    Fasting PINP (Procollagen I Intact N-Terminal)in Serum, measured in mcg/L

  6. 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

  7. 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.

  8. 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.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608801


Locations
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Norway
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, Norway, 0408
University Hospital of North Norway
Tromsø, Norway
Sponsors and Collaborators
Oslo University Hospital
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
Investigators
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Study Director: Åshild Bjørnerem, Dr Med The Arctic University of Norway

Additional Information:
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Responsible Party: Frede Frihagen, Consultant, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02608801    
Other Study ID Numbers: 2014/2260REK OS
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Ankle Fractures
Humeral Fractures
Fractures, Compression
Osteoporotic Fractures
Shoulder Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Arm Injuries
Shoulder Injuries