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.
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).


CONCLUSIONS
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.
Oglesby
Alan K
AK
Eli Lilly and Company, Global Economic Affairs, Indianapolis, Indiana 46285, USA. aoglesby@lilly.com
Minshall
Michael E
ME
Shen
Wei
W
Xie
Sunny
S
Silverman
Stuart L
SL
D000368:Aged; D004311:Double-Blind Method; D005260:Female; D005598:Fractures, Spontaneous / Q000150:complications* / Q000503:physiopathology / Q000517:prevention & control; D006304:Health Status; D006801:Humans; D007279:Injections, Subcutaneous; D015663:Osteoporosis, Postmenopausal / Q000150:complications* / Q000188:drug therapy / Q000503:physiopathology; D011788:Quality of Life; D012646:Self Administration; D016103:Spinal Fractures / Q000150:complications* / Q000503:physiopathology / Q000517:prevention & control; D011795:Surveys and Questionnaires; D019379:Teriparatide / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome
D019379:Teriparatide