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  • Title: 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.
    Author: Oglesby AK, Minshall ME, Shen W, Xie S, Silverman SL.
    Journal: J Rheumatol; 2003 Jul; 30(7):1579-83. PubMed ID: 12858462.
    Abstract:
    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.
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