TY - JOUR T1 - The impact of incident vertebral and non-vertebral fragility fractures on health-related quality of life in established postmenopausal osteoporosis: results from the teriparatide randomized, placebo-controlled trial in postmenopausal women. JF - The Journal of Rheumatology JO - J Rheumatol SP - 1579 LP - 1583 VL - 30 IS - 7 AU - Alan K Oglesby AU - Michael E Minshall AU - Wei Shen AU - Sunny Xie AU - Stuart L Silverman Y1 - 2003/07/01 UR - http://www.jrheum.org/content/30/7/1579.abstract N2 - OBJECTIVE: To report the combined impact of both vertebral and non-vertebral fractures on decreased health-related quality of life (HRQOL) in postmenopausal women (mean age 70.7) with osteoporosis who participated in a clinical trial to examine the anti-fracture efficacy of teriparatide [rhPTH(1-34)] injection. METHODS: Patients were randomly assigned to 1 of 3 study arms: placebo, 20 micro g or 40 micro g of teriparatide by daily self-injection. All patients received daily calcium (1000 mg) and vitamin D (400-1200 U) supplements. Patients were followed for a median of 21 months. Incident vertebral fractures were assessed by lateral spinal radiograph. Incident non-vertebral fractures were ascertained by patient self-report and verified by a review of radiological reports. HRQOL was assessed at baseline and annually until study termination using the Osteoporosis Assessment Questionnaire (OPAQ), a validated disease-targeted instrument. RESULTS: Of the 365 women in the HRQOL sub-study, 53 had an incident vertebral or non-vertebral fracture during the study period. Compared to women without incident fractures, women who fractured reported significant declines in physical functioning, emotional status, and symptoms (all p < 0.05). Similarly, when analysis was limited to patients with significant loss in HRQOL, patients with incident fracture accounted for a greater proportion of those patients with decreased physical function, emotional status, and increased symptoms (all p < 0.05). CONCLUSION: Our results confirm and extend previous findings to show that a composite endpoint of incident vertebral and non-vertebral fractures in women with postmenopausal osteoporosis was associated with significant decreases in HRQOL. ER -