HEALTH-RELATED QUALITY-OF-LIFE AND PARTICIPATION IN OSTEOPOROSIS CLINICAL-TRIALS

Although osteoporosis affects millions of elderly women, the quality o f their lives is extremely complex and is only recently being apprecia ted. We recently used a disease-specific Osteoporosis Quality of Life questionnaire (OQLQ) to measure quality of life for 105 elderly osteop orotic women, and reported that by path analysis, spinal fractures, he alth perception, and several sociodemographic factors accounted for 63 % of the variance in quality of life. On the other hand, bone density, Colles fracture, hip fractures, pharmacologic agents, exercise, and s everal sociodemographic variables were not significant factors. Of par ticular note was the positive, indirect effect (via health perception and spinal fractures) that participation in a clinical trial (17.5% of the patients) had on life quality. In order to determine how involvem ent in a research study might affect health perception in this same co hort we examined OQLQ scores in the five domains of the OQLQ for the 1 8 postmenopausal osteoporotic women enrolled in two different phase II I clinical trials with oral bisphosphonates and 87 osteoporotic women treated conventionally (estrogen, bisphosphonate, calcitonin, calcium/ vitamin D) in our metabolic bone clinic. Research and clinical patient s did not differ in age, femoral BMD, or number of spinal fractures. H owever, women in research trials had significantly greater aggregate O QLQ scores (5.67 versus 4.23, P < 0.0001) and perceived health (7.28 v ersus 5.85, P = 0.001) than clinical patients. These differences were highly significant (P < 0.001) for domains of quality of life includin g physical function, activities of daily living, symptoms, and leisure /social activity and marginally significant for the emotional function domain (P = 0.05). Hence, by regression-based path analysis and subgr oup analysis of cross-sectional data, participation in a clinical tria l had a significant and positive impact on health-related quality of l ife. If these findings are confirmed by other studies, identifying tho se factors inherent in clinical studies that positively impact the liv es of osteoporotic patients should become as important a priority as d evelopment of new therapies for this chronic disease.