OBJECTIVE: To examine the association between back pain and health related quality of life (HRQOL) in postmenopausal women with osteoporosis. METHODS: The Fracture Prevention Trial was a prospective double blinded, placebo controlled study designed to compare the proportion of women receiving teriparatide who experienced a new fracture to the proportion of women receiving placebo who experienced a new fracture. Subjects were ambulatory postmenopausal women with osteoporosis and prior vertebral fracture. As part of this trial, English-speaking women from Canada, New Zealand, Australia, and the United States participated in a HRQOL substudy using the Osteoporosis Assessment Questionnaire (OPAQ). OPAQ was administered at baseline, 12 months, and at study termination (median treatment duration 19 mo). Back pain data were collected as part of the adverse event monitoring during the trial. Subjects considered to have experienced back pain reported this event spontaneously and were not queried specifically. We examined the influence of prevalent back pain on HRQOL after controlling for spine deformity index score, and the influence of new or worsening back pain on HRQOL after controlling for incident vertebral fracture. RESULTS: Of 471 women who completed OPAQ at baseline, 172 reportedback pain that was associated with a mean decrease in all OPAQ dimension scores (p < 0.05). Of 429 women who completed OPAQ at all timepoints, 88 experienced new or worsening back pain that was associated with a mean decrease in physical function, emotional status, and symptoms scores (p < 0.01 for each). In a subset of 65 women who experienced moderate to severe back pain, all OPAQ dimensions were significantly reduced (p < 0.05). CONCLUSION: Both prevalent back pain and new or worsening back pain affected HRQOL negatively. Osteoporosis therapies that prevent the development of back pain in postmenopausal women may also prevent decreases in HRQOL.
RCT Entities:
OBJECTIVE: To examine the association between back pain and health related quality of life (HRQOL) in postmenopausal women with osteoporosis. METHODS: The Fracture Prevention Trial was a prospective double blinded, placebo controlled study designed to compare the proportion of women receiving teriparatide who experienced a new fracture to the proportion of women receiving placebo who experienced a new fracture. Subjects were ambulatory postmenopausal women with osteoporosis and prior vertebral fracture. As part of this trial, English-speaking women from Canada, New Zealand, Australia, and the United States participated in a HRQOL substudy using the Osteoporosis Assessment Questionnaire (OPAQ). OPAQ was administered at baseline, 12 months, and at study termination (median treatment duration 19 mo). Back pain data were collected as part of the adverse event monitoring during the trial. Subjects considered to have experienced back pain reported this event spontaneously and were not queried specifically. We examined the influence of prevalent back pain on HRQOL after controlling for spine deformity index score, and the influence of new or worsening back pain on HRQOL after controlling for incident vertebral fracture. RESULTS: Of 471 women who completed OPAQ at baseline, 172 reported back pain that was associated with a mean decrease in all OPAQ dimension scores (p < 0.05). Of 429 women who completed OPAQ at all timepoints, 88 experienced new or worsening back pain that was associated with a mean decrease in physical function, emotional status, and symptoms scores (p < 0.01 for each). In a subset of 65 women who experienced moderate to severe back pain, all OPAQ dimensions were significantly reduced (p < 0.05). CONCLUSION: Both prevalent back pain and new or worsening back pain affected HRQOL negatively. Osteoporosis therapies that prevent the development of back pain in postmenopausal women may also prevent decreases in HRQOL.
Authors: M C Nevitt; P Chen; D P Kiel; J-Y Reginster; R K Dore; J R Zanchetta; E V Glass; J H Krege Journal: Osteoporos Int Date: 2006-08-08 Impact factor: 4.507
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