title: Back pain-related disability and quality of life in patients affected by vertebral fractures: data from baseline characteristics of population enrolled in Denosumab In Real Practice (DIRP).
abstract: BACKGROUND
  Spine fragility fractures lead to a significant acute and/or chronic pain and worsening of quality of life. Denosumab is effective in reducing the risk of new vertebral fractures, but its effectiveness on pain relief and improvement of the quality of life in patients with spine fractures are not well known.
  
  
  OBJECTIVE
  The aim of this paper is to describe the baseline demographic and clinical characteristics, back pain-related disability and quality of life of the Denosumab In Real Practice (DIRP) study population.
  
  
  METHODS
  DIRP is a multicenter prospective observational study evaluating the effectiveness of denosumab in reducing back pain-related disability and Health-Related Quality of Life (HRQoL) of women with postmenopausal osteoporosis who had already experienced at least one vertebral fragility fracture. Our evaluation protocol includes history of fractures, Spine Pain Index (SPI), HRQoL, bone mineral density (BMD) and radiological assessment of vertebral fragility fractures.
  
  
  RESULTS
  Two hundred and twenty-three post-menopausal women, who received a prescription for denosumab, were enrolled. The mean SPI score was 58.6 ± 21.4 SD, and 187 (83.86%) women experienced a moderate-severe pain. The mean HRQoL health state value was 0.54 ± 0.27 SD using EQ-5D index, whereas the mean Physical and Mental Health Composite Scale scores derived from the SF-12 were 31.06 ± 7.77 SD and 39.20 ± 11.03 SD.
  
  
  CONCLUSIONS
  Baseline characteristics of DIRP study cohort indicate that patients who received a prescription of denosumab in Campania region are affected by severe osteoporosis with highly prevalent vertebral fractures, disabling back pain and poor health-related quality of life. This is in contradiction with what it is expected by a front-line drug for osteoporosis.
authors.affiliation: Department of Medical and Surgical Specialties and Dentistry, Second University of Naples, Naples, Italy.
authors.forename: Antimo
authors.initials: A
authors.lastname: Moretti
authors.affiliation: Department of Mental and Physical Health and Preventive Medicine, Second University of Naples, Naples, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Gimigliano
authors.affiliation: Department of Medical and Surgical Specialties and Dentistry, Second University of Naples, Naples, Italy.
authors.forename: Gioconda
authors.initials: G
authors.lastname: Di Pietro
authors.affiliation: Department of Medical and Surgical Specialties and Dentistry, Second University of Naples, Naples, Italy.
authors.forename: Raffaele
authors.initials: R
authors.lastname: Gimigliano
authors.affiliation: Department of Medical and Surgical Specialties and Dentistry, Second University of Naples, Naples, Italy. giovanni.iolascon@gmail.com.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Iolascon
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001416:Back Pain / Q000175:diagnosis / Q000188:drug therapy / Q000453:epidemiology / Q000209:etiology / Q000523:psychology; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000627:therapeutic use; D000069448:Denosumab / Q000627:therapeutic use*; D004185:Disability Evaluation; D005260:Female; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy / Q000453:epidemiology; D010147:Pain Measurement; D011446:Prospective Studies; D011788:Quality of Life; D016103:Spinal Fractures / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy / Q000453:epidemiology / Q000523:psychology; D016896:Treatment Outcome
chemical_list: D050071:Bone Density Conservation Agents; D000069448:Denosumab
keywords: Back pain; Denosumab; Disability; Osteoporosis; Quality of life; Vertebral fractures