title: Once-yearly zoledronic acid and days of disability, bed rest, and back pain: randomized, controlled HORIZON Pivotal Fracture Trial.
abstract: The objective of this study was to determine the effect of once-yearly zoledronic acid on the number of days of back pain and the number of days of disability (ie, limited activity and bed rest) owing to back pain or fracture in postmenopausal women with osteoporosis. This was a multicenter, randomized, double-blind, placebo-controlled trial in 240 clinical centers in 27 countries. Participants included 7736 postmenopausal women with osteoporosis. Patients were randomized to receive either a single 15-minute intravenous infusion of zoledronic acid (5 mg) or placebo at baseline, 12 months, and 24 months. The main outcome measures were self-reported number of days with back pain and the number of days of limited activity and bed rest owing to back pain or a fracture, and this was assessed every 3 months over a 3-year period. Our results show that although the incidence of back pain was high in both randomized groups, women randomized to zoledronic acid experienced, on average, 18 fewer days of back pain compared with placebo over the course of the trial (p = .0092). The back pain among women randomized to zoledronic acid versus placebo resulted in 11 fewer days of limited activity (p = .0017). In Cox proportional-hazards models, women randomized to zoledronic acid were about 6% less likely to experience 7 or more days of back pain [relative risk (RR) = 0.94, 95% confidence interval (CI) 0.90-0.99] or limited activity owing to back pain (RR = 0.94, 95% CI 0.87-1.00). Women randomized to zoledronic acid were significantly less likely to experience 7 or more bed-rest days owing to a fracture (RR = 0.58, 95% CI 0.47-0.72) and 7 or more limited-activity days owing to a fracture (RR = 0.67, 95% CI 0.58-0.78). Reductions in back pain with zoledronic acid were independent of incident fracture. Our conclusion is that in women with postmenopausal osteoporosis, a once-yearly infusion with zoledronic acid over a 3-year period significantly reduced the number of days that patients reported back pain, limited activity owing to back pain, and limited activity and bed rest owing to a fracture.
authors.affiliation: Department of Epidemiology, University of Pittsburgh, Pittsburgh, PA 15261, USA. JCauley@edc.pitt.edu
authors.forename: Jane A
authors.initials: JA
authors.lastname: Cauley
authors.forename: Dennis
authors.initials: D
authors.lastname: Black
authors.forename: Steven
authors.initials: S
authors.lastname: Boonen
authors.forename: Steven R
authors.initials: SR
authors.lastname: Cummings
authors.forename: Peter
authors.initials: P
authors.lastname: Mesenbrink
authors.forename: Lisa
authors.initials: L
authors.lastname: Palermo
authors.forename: Zulema
authors.initials: Z
authors.lastname: Man
authors.forename: Peyman
authors.initials: P
authors.lastname: Hadji
authors.forename: Ian R
authors.initials: IR
authors.lastname: Reid
mesh_terms: D001416:Back Pain / Q000150:complications* / Q000188:drug therapy*; D001510:Bed Rest; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000627:therapeutic use; D004164:Diphosphonates / Q000008:administration & dosage* / Q000627:therapeutic use*; D006233:Persons with Disabilities; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage* / Q000627:therapeutic use*; D015999:Multivariate Analysis; D015995:Prevalence; D011336:Probability; D012307:Risk Factors; D016103:Spinal Fractures / Q000150:complications* / Q000188:drug therapy*; D000077211:Zoledronic Acid
chemical_list: D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D007093:Imidazoles; D000077211:Zoledronic Acid