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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.
J Rheumatol. 2003 Jul; 30(7):1579-83.JR

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.

Authors+Show Affiliations

Eli Lilly and Company, Global Economic Affairs, Indianapolis, Indiana 46285, USA. aoglesby@lilly.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

12858462

Citation

Oglesby, Alan K., et al. "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." The Journal of Rheumatology, vol. 30, no. 7, 2003, pp. 1579-83.
Oglesby AK, Minshall ME, Shen W, et al. 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. J Rheumatol. 2003;30(7):1579-83.
Oglesby, A. K., Minshall, M. E., Shen, W., Xie, S., & Silverman, S. L. (2003). 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. The Journal of Rheumatology, 30(7), 1579-83.
Oglesby AK, et al. 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. J Rheumatol. 2003;30(7):1579-83. PubMed PMID: 12858462.
* Article titles in AMA citation format should be in sentence-case
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. AU - Oglesby,Alan K, AU - Minshall,Michael E, AU - Shen,Wei, AU - Xie,Sunny, AU - Silverman,Stuart L, PY - 2003/7/15/pubmed PY - 2003/10/28/medline PY - 2003/7/15/entrez SP - 1579 EP - 83 JF - The Journal of rheumatology JO - J Rheumatol VL - 30 IS - 7 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. SN - 0315-162X UR - https://www.unboundmedicine.com/medline/citation/12858462/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_ L2 - http://www.jrheum.org/cgi/pmidlookup?view=long&amp;pmid=12858462 DB - PRIME DP - Unbound Medicine ER -