Baseline observations from the POSSIBLE EU® study: characteristics of postmenopausal women receiving bone loss medications

Abstract

SummaryProspective Observational Scientific Study Investigating Bone Loss Experience in Europe (POSSIBLE EU®) is an ongoing longitudinal cohort study that utilises physician- and patient-reported measures to describe the characteristics and management of postmenopausal women on bone loss therapies. We report the study design and baseline characteristics of 3,402 women recruited from general practice across five European countries.PurposeThe POSSIBLE EU® is a study describing the characteristics and management of postmenopausal women receiving bone loss medications.MethodsBetween 2005 and 2008, general practitioners enrolled postmenopausal women initiating, switching or continuing treatment with bone loss treatment in France, Germany, Italy, Spain and the UK. Patients and physicians completed questionnaires at study entry and at 3-month intervals, for 1 year.ResultsOf 3,402 women enrolled (mean age 68.2 years [SD] 9.83), 96% were diagnosed with low bone mass; 55% of these using dual energy X-ray absorptiometry. Most women (92%) had comorbidities. Mean minimum T score (hip or spine) at diagnosis was −2.7 (SD 0.89; median −2.7 [interquartile range, −3.2, −2.2]) indicating low bone mineral density. Almost 40% of the women had prior fractures in adulthood, mostly non-vertebral, non-hip in nature, 30% of whom had at least two fractures and more than half experienced moderate/severe pain or fatigue. Bisphosphonates were the most common type of bone loss treatment prescribed in the 12 months preceding the study.ConclusionsPOSSIBLE EU® characterises postmenopausal women with low bone mass, exhibiting a high rate of prevalent fracture, substantial bone fragility and overall comorbidity burden. Clinical strategies for managing osteoporosis in this population varied across the five participating European countries, reflecting their different guidelines, regulations and standards of care.

Prevalence of osteoporosis and fractures among women prescribed osteoporosis medication in five European countries: the POSSIBLE EU® study

“…For each of the participating countries, representative primary care centers were selected as described previously [14], taking into account a range of variables including broad geographical region, urban/rural location, physician gender, and the practice size. General practitioners who were willing and able to be involved with POSSIBLE EU® were selected from these centers.…”

“…At study entry, investigators at all sites collected the following data for each patient: demographics, bone loss diagnosis (no, yes, unknown/missing), method used at time of diagnosis (X-ray, ultrasound, DXA, clinical history, other, unknown/missing), fracture history during adulthood (≥18 years of age), bone loss treatment in adulthood, comorbidities, and concomitant medications [14].…”

“…For the 3,402 patients, the most common diagnostic methods were DXA (52% of patients), standard X-ray (24%), and clinical history (11%). Diagnostic approaches have been previously described in more detail [14]. Of 1,784 patients who had DXA results available at diagnosis, 68% (1,216) had osteoporosis, 31% (548) had osteopenia, and 1.1% (20) were "unknown" (Fig.…”

“…POSSIBLE EU® is one of the few osteoporosis treatment cohort studies being conducted in Europe [14]. However, the Incidence and ChAracterization of inadequate clinical Responders in Osteoporosis (ICARO) study has also been described [19].…”

The 21st-Century Landscape of Adult Fractures: Cohort Study of a Complete Adult Regional Population

“…Because hip fracture is generally considered the worst fracture in the elderly, its epidemiology has been extensively examined and used as a surrogate for the burden of osteoporosis on society. Even though other fracture types are not individually causing as much postfracture mortality and morbidity, recent studies have pointed out that as much as 90% of fractures in elderly women are nonhip fractures . Together, these account for three times more hospital days and four times more days of rehabilitation and/or nursing home care than hip fractures .…”