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

NCT02234414 | Completed

• 1 other identifier: IGO-SwOF 01
• Study Type: observational
• Target: 303
• Locations: 1 country
• Sites: 3

Brief Summary

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%.

Conditions

Postmenopausal Osteoporosis; Spinal Fractures

Keywords

vertebral fracture assessment (vfa); vitamin D

Outcome Measures

Primary Outcomes (1)

• Prevalence of vertebral fractures in community dwelling Swiss women aged 65-79 years

  at the only study visit

Secondary Outcomes (3)

• 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

Eligibility Criteria

• Age: 65 Years - 79 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prof. Dr. med. Kurt Lippuner: lead

Study Sites (3)

Kantonsspital Olten

Olten, CH-4600, Switzerland

Location

HFR Tafers

Tafers, CH-1712, Switzerland

Location

Hochgebirgsklinik Davos

Wolfgang, CH-7265, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Spinal Fractures

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Kurt Lippuner, Prof. Dr.

  Interessengemeinschaft Osteoporose

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: June 29, 2011
• First Posted: September 9, 2014
• Study Start: February 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: June 1, 2011
• Last Updated: September 9, 2014

Record last verified: 2014-09

Locations

CH (3)