Prediction and Secondary Prevention of Fractures

Completed

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

• Registration Number: NCT02608801
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-11-17
• Study First Submitted QC: 2015-11-17
• Study First Posted: 2015-11-20
• Primary Completion: 2017-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-03
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 840

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fragility fractures	2 years	Number of new fractures during observation periode

Secondary Outcome Measures

Name	Time	Method
Trabecular Bone Score (TBS)	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
s-PINP	At 1 year follow-up	Fasting PINP (Procollagen I Intact N-Terminal)in Serum, measured in mcg/L
FRAX score	Baseline	Calculation 10-year fracture risk for major osteoporotic and hip fractures by FRAX calculated during DXA scanning, on a population treated with AOD
Garvan score	Baseline	Calculation of 10-year fracture risk for major osteoporotic and hip fracture using online available Garvan Nomogram, on a population treated with AOD.
Spinal Deformity Index (SDI)	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
s-CTX	At 1 year follow-up	Fasting CTX (carboxy-terminal collagen crosslinks)in serum, measured in pg/ml
Bone mineral Density (BMD)	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
Self-reported adherence to anti-osteoporotic drugs (AOD)	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.

Trial Locations

Locations (6)

Orthopedic Center, Ulleval University Hospital; 🇳🇴 Oslo, Norway

Drammen hospital; 🇳🇴 Drammen, Norway

Baerum Hospital; 🇳🇴 Sandvika, Gjettum, Norway

University Hospital of North Norway; 🇳🇴 Tromsø, Norway

St. Olavs Hospital; 🇳🇴 Trondheim, Trønderlag, Norway

Molde Hospital; 🇳🇴 Molde, Norway