title: An observational study to assess back pain in patients with severe osteoporosis treated with teriparatide versus antiresorptives: An Indian subpopulation analysis.
abstract: BACKGROUND
  One year, prospective, observational study in an Indian subpopulation to assess back pain in patients with severe osteoporosis treated with teriparatide or antiresorptives in a clinical setting.
  
  
  METHODS
  One hundred and nineteen teriparatide-naοve Indian men and postmenopausal women (mean age 68.0 years) with previous osteoporotic vertebral fracture participated. Patients were assessed at baseline, 6-and 12-months to evaluate relative risk (RR) of new/worsening back pain using the Back Pain Questionnaire. The incidence of back pain and changes in back pain severity were assessed using the visual analog scale (VAS); Health outcomes were assessed using the euroquol-5 dimensions (EQ-5D) questionnaire. All tests were conducted with a two-sided alpha of 0.05.
  
  
  RESULTS
  Of 562 overall patients, 57, 60, and 2 Indian patients received teriparatide, antiresorptive, or teriparatide and antiresorptive, respectively. Baseline disease characteristics were slightly worse for antiresorptive-treated patients, whereas teriparatide-treated patients were older with more comorbidities. At 6-months, the incidence of new/worsening back pain was 5.3% for teriparatide-treated patients versus 4.4% for antiresorptive-treated patients (RR: 1.00, 95% confidence interval: 0.68, 1.48); the incidence of severe back pain was 0% versus 12.5% (P = 0.017); in these treatment groups, respectively. Mean VAS change scores (mean ± standard deviation [SD]) were - 1.9 ± 1.73 versus - 1.4 ± 1.77, and mean EQ-5D change scores were 4.2 ± 27.20 versus 9.9 ± 26.23 at 6-months. At 6 months, more teriparatide-treated patients felt better (89% vs. 61%; P = 0.001) and were at least very satisfied with their treatment (30% vs. 9%; P = 0.011).
  
  
  CONCLUSIONS
  Teriparatide-treated Indian patients had similar new/worsening back pain risk and minimal risk of severe back pain compared with antiresorptive-treated patients at 6-months.
authors.affiliation: Medical Director and Chief of Spine Services, Indian Spinal Injuries Centre, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Harvinder
authors.initials: H
authors.lastname: Chhabra
authors.affiliation: Consultant Orthopedic Surgeon, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Rajesh
authors.initials: R
authors.lastname: Malhotra
authors.affiliation: Orthopedic Surgeon, Marwah Clinic, Gurgaon, India.
authors.forename: Sunil
authors.initials: S
authors.lastname: Marwah
authors.affiliation: Orthopedic Surgeon, Stavya Spine Hospital and Research Institute, Ellisbridge, Ahmedabad, India.
authors.forename: Bharat
authors.initials: B
authors.lastname: Dave
authors.affiliation: Principal Research Scientist, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, USA.
authors.forename: Kyoungah
authors.initials: K
authors.lastname: See
authors.affiliation: Ethics and Compliance Officer, Eli Lilly and Company (India) Pvt. Ltd., Gurgaon, India.
authors.forename: Simrat
authors.initials: S
authors.lastname: Sohal
authors.affiliation: Senior Medical Advisor, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, USA.
authors.forename: Sirel
authors.initials: S
authors.lastname: Gurbuz
keywords: Antiresorptives; back pain; fractures; osteoporosis; teriparatide