Prediction and Secondary Prevention of Fractures (NOFRACTsub)

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: Completed
• Conditions: Hip Fractures; Ankle Fractures; Osteoporotic Fractures; Humeral Fractures, Proximal; Vertebral Compression Fractures; Wrist Fractures

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: Observational
• Enrollment (Actual): 840

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fragility fractures	Number of new fractures during observation periode	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	Baseline, 2 years
s-CTX	Fasting CTX (carboxy-terminal collagen crosslinks)in serum, measured in pg/ml	At 1 year follow-up
s-PINP	Fasting PINP (Procollagen I Intact N-Terminal)in Serum, measured in mcg/L	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	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.	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.	Baseline, 1 year, 2 years

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: 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: Study Director: Åshild Bjørnerem, Dr Med, The Arctic University of Norway

Publications and helpful links

Helpful Links

• NoFRACT

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: November 17, 2015
• First Submitted That Met QC Criteria: November 17, 2015
• First Posted (Estimate): November 20, 2015

Study Record Updates

• Last Update Posted (Actual): March 4, 2020
• Last Update Submitted That Met QC Criteria: March 3, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Shoulder Injuries; Femoral Fractures; Hip Injuries; Arm Injuries; Fractures, Bone; Hip Fractures; Ankle Fractures; Fractures, Compression; Humeral Fractures; Shoulder Fractures; Osteoporotic Fractures
• Other Study ID Numbers: 2014/2260REK OS