title: Baseline characteristics of the population enrolled in the Italian Observational Study on Severe Osteoporosis (ISSO).
abstract: OBJECTIVE
  Baseline characteristics of the population enrolled in the ISSO study, designed to evaluate the incidence of vertebral and non-vertebral fractures in Italian patients with severe osteoporosis treated according to clinical practice over 24 months observation.
  
  
  METHODS
  Prospective observational study in 783 post-menopausal women and men entering 18-month treatment with teriparatide in a community setting at 57 centres in Italy. Characterisation included demographics, fracture risk factors, bone mineral density, fracture status, Health-Related Quality of Life (HRQoL) measured by the European Quality of Life Questionnaire, EQ-5D, and back pain assessed by VAS.
  
  
  RESULTS
  Most patients were elderly women (90.5%), mean age±SD was 72.9±8.8 years. Nearly all (91.3%) had experienced ≥ 1 vertebral fracture (mean±SD, 3.6±2.2 per patient), 37.5% had ≥ 1 non-vertebral fracture (mean±SD, 1.4±0.7 per patient). Nearly all patients were suffering from back pain (94.9%), which had significantly restricted their daily activities (51.7%) and had likely or very likely been caused by vertebral fractures (29.2% and 55.8%, respectively). Mean EuroQoL EQ-5D index value was 0.58±0.25 and VAS score 49.2±23.6. Non-vertebral fractures, back pain and multiple vertebral fractures were associated with lower HRQoL (EuroQoL-5D Index both p<0.001, EQ-5D VAS score p=0.025 and p<0.016, respectively). Many patients were physically inactive (81.1%). One third (34.7%) of population had co-morbidities and 60.5% were on chronic concomitant treatments. Few subjects reported a maternal history of osteoporosis (15.5%), regular consumption of alcohol (13.3%) or were current smokers (11.5%). Nearly two-thirds (71.5%) had already been treated for osteoporosis, mainly with bisphosphonates. Calcium and vitamin D supplements were taken by 13% and 15.5% of the total population, respectively.
  
  
  CONCLUSIONS
  At enrollment, the population of ISSO study mostly consisted in aging women, who had osteoporosis with high fracture risk, poor HRQoL and suffered from significant back pain. Most of them had already been treated by bisphosphonates but without calcium and vitamin D supplements. Back pain, as well as non-vertebral and multiple vertebral fractures, were associated with lower HRQoL.
authors.affiliation: Unità Riabilitazione Reumatologica Osseo-Articolare, Ospedale Maggiore Borgo Trento, Verona, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Adami
authors.forename: D
authors.initials: D
authors.lastname: Maugeri
authors.forename: V
authors.initials: V
authors.lastname: Toscano
authors.forename: G
authors.initials: G
authors.lastname: Topa
authors.forename: M
authors.initials: M
authors.lastname: Carminiti
authors.forename: A
authors.initials: A
authors.lastname: Brancati
authors.forename: M
authors.initials: M
authors.lastname: Massarotti
authors.forename: G
authors.initials: G
authors.lastname: Osella
authors.forename: N
authors.initials: N
authors.lastname: Malavolta
authors.forename: G
authors.initials: G
authors.lastname: Iolascon
authors.forename: C
authors.initials: C
authors.lastname: Cagnoni
authors.forename: V
authors.initials: V
authors.lastname: Camozzi
authors.forename: C
authors.initials: C
authors.lastname: Corradini
authors.forename: A
authors.initials: A
authors.lastname: Nardi
authors.forename: S
authors.initials: S
authors.lastname: Migliaccio
authors.forename: F M
authors.initials: FM
authors.lastname: Ulivieri
authors.forename: G
authors.initials: G
authors.lastname: Resmini
authors.forename: D
authors.initials: D
authors.lastname: Valle
authors.forename: L
authors.initials: L
authors.lastname: Tauchmanovà
authors.forename: S
authors.initials: S
authors.lastname: Silvestri
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001416:Back Pain / Q000453:epidemiology / Q000209:etiology; D050071:Bone Density Conservation Agents / Q000627:therapeutic use; D015331:Cohort Studies; D003625:Data Collection; D005260:Female; D050723:Fractures, Bone / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D006801:Humans; D015994:Incidence; D007558:Italy / Q000453:epidemiology; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D010024:Osteoporosis / Q000150:complications / Q000453:epidemiology* / Q000503:physiopathology*; D011446:Prospective Studies; D011788:Quality of Life; D012189:Retrospective Studies; D012307:Risk Factors; D012720:Severity of Illness Index; D016103:Spinal Fractures / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D019379:Teriparatide / Q000627:therapeutic use
chemical_list: D050071:Bone Density Conservation Agents; D019379:Teriparatide