Epidemiology, Identification Rate and Treatment Penetration of Osteoporotic Vertebral Fractures in Switzerland (SwOF)

Pilot Study on the Epidemiology, Identification Rate and Treatment Penetration of Vertebral Fractures Due to Osteoporosis in Switzerland (SwOF)

In Switzerland, the prevalence of vertebral fractures in community- dwelling women is unknown and the published data from the Swiss hospitals statistics represent only the tip of the iceberg. In addition, the percentages of women correctly identified with vertebral fractures due to osteoporosis and the treatment rate of these women with a drug proven to reduce the risk of further fractures are unknown. Furthermore, it is not known whether the prevalence of vertebral fractures differs between urban and rural areas or between mountain areas and plain country, e.g. due to possible differences in sun exposure (vitamin D production) and/ or in physical activity and/ or dietary habits.

Clinical signs and symptoms leading to the suspicion of vertebral fracture(s) lack either sensitivity (wall-occiput distance) or specificity (rib-pelvis distance). Whether a combination of both would improve sensitivity and specificity is unknown.

The gold standard for the diagnosis of vertebral fracture relies on antero-posterior and lateral X-Rays of the thoracic and lumbar spine. Despite standardization of X-Ray readings, a retrospective study of hospitalized elderly patients has shown that as many as 50% of the radiographic reports failed to note the presence of moderate to severe vertebral fractures. In a primary care setting, fewer than 2% of the women received diagnoses of osteoporosis or vertebral fracture, although expected prevalence is 20% to 30% and appropriate drug treatment was offered to only 36% of the diagnosed patients.

The recent availability of software for vertebral fracture assessment (VFA) coupled to DXA measurements allows for the detection of vertebral deformities, which is critical for management of osteoporosis, as the existence of such deformities substantially increases the risk of subsequent fracture. Recently published results show that VFA allows the diagnosis of a vertebral fracture. The sensitivity of VFA for detection of vertebral fractures compared to expert radiologist reading of X-ray is excellent for grade 2 and 3 fractures, ranging between 90-94%.

Study Overview

• Status: Completed
• Conditions: Spinal Fractures; Postmenopausal Osteoporosis

Detailed Description

Examinations

• Community-dwelling women from a random sample (address lists may be chosen from public and/ or private providers)
• Aged 65-79 yrs
• Written informed consent

• Study Type: Observational
• Enrollment (Actual): 303

Contacts and Locations

Study Locations

• Switzerland
  • Davos-Wolfgang, Switzerland, CH-7265
    • Hochgebirgsklinik Davos
  • Olten, Switzerland, CH-4600
    • Kantonsspital Olten
  • Tafers, Switzerland, CH-1712
    • HFR Tafers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 79 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

The study population will be based on a representative (age categories, urban vs. rural, plain vs. mountain) stratified random sample taken from the general population of women living in urban/ suburban and country/ mountain regions (stratified for n = one third each, based on city code) in the german speaking part of Switzerland.

Description

Inclusion Criteria:

• Community-dwelling women from a random sample (address lists may be chosen from public and/ or private providers)
• Aged 65-79 yrs
• Written informed consent

Exclusion Criteria:

• Patients who underwent spine surgery
• Not willing or not able to sign informed consent
• In patients not willing or not able to participate, the reason for denial will be recorded for future evaluation.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Prevalence of vertebral fractures in community dwelling Swiss women aged 65-79 years	at the only study visit

Secondary Outcome Measures

Outcome Measure	Time Frame
Specificity, sensitivity, positive predictive value and negative predictive value for the prediction of underlying vertebral fracture of selected risk factors, clinical signs and vitamin D level, alone or in combination	at the only study visit
Assessment of the percentage of women correctly identified with a vertebral fracture and adequately treated for underlying osteoporosis and	at the only study visit
Assessment of the differences between these women and those who are either not correctly diagnosed or not correctly treated	at the only study visit

Collaborators and Investigators

• Sponsor: Prof. Dr. med. Kurt Lippuner
• Investigators: Principal Investigator: Kurt Lippuner, Prof. Dr., Interessengemeinschaft Osteoporose

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: June 29, 2011
• First Submitted That Met QC Criteria: September 8, 2014
• First Posted (Estimate): September 9, 2014

Study Record Updates

• Last Update Posted (Estimate): September 9, 2014
• Last Update Submitted That Met QC Criteria: September 8, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: vitamin D; vertebral fracture assessment (vfa)
• Additional Relevant MeSH Terms: Metabolic Diseases; Wounds and Injuries; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Spinal Injuries; Back Injuries; Fractures, Bone; Osteoporosis; Osteoporosis, Postmenopausal; Spinal Fractures
• Other Study ID Numbers: IGO-SwOF 01