Inclusion of Older Women in Randomized Clinical Trials: Factors Associated with Taking Study Medication in the Fracture Intervention Trial

OBJECTIVES: The purpose of this study is to describe the early study medication discontinuation (SMD) experience during the first year of follow‐up in a randomized clinical trial in older women and to determine the associations between various baseline characteristics and risk of SMD. DESIGH, SETTIN...

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Bibliographic Details
Published in:	Journal of the American Geriatrics Society (JAGS) Vol. 48; no. 9; pp. 1126 - 1131
Main Authors:	Buist, Diana S.M., LaCroix, Andrea Z., Black, Dennis M., Harris, Fran, Blank, Jan, Ensrud, Kristine, Edgerton, Donna, Rubin, Susan, Fox, Kathleen M.
Format:	Journal Article
Language:	English
Published:	Oxford, UK Blackwell Publishing Ltd 01-09-2000 Blackwell Wiley Subscription Services, Inc
Subjects:	adherence Aged - psychology Aged, 80 and over Alendronate - adverse effects Analysis. Health state Biological and medical sciences Cessation Clinical trial. Drug monitoring Clinical trials Comorbidity controlled trial Depression - psychology Drugs Elderly women Epidemiology Female Follow-Up Studies Fractures, Bone - etiology Fractures, Bone - prevention & control General aspects General pharmacology Geriatrics Health Status Humans intervention Medical sciences Middle Aged Multicenter Studies as Topic - psychology Osteoporosis, Postmenopausal - complications Osteoporosis, Postmenopausal - psychology Patient Dropouts - psychology Patient Selection Pharmacology. Drug treatments Predictive Value of Tests Prescription drugs Public health. Hygiene Public health. Hygiene-occupational medicine randomized clinical trials Randomized Controlled Trials as Topic - psychology Risk Factors study withdrawal Surveys and Questionnaires Treatment Refusal - psychology USA Women Women - psychology United States North America America Human Diseases of the osteoarticular system Vertebra Fracture Trauma Prevention Chemotherapy Treatment Follow up study Cohort study Postmenopause Clinical trial Female Treatment compliance Predictive factor Elderly Public health
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Summary:	OBJECTIVES: The purpose of this study is to describe the early study medication discontinuation (SMD) experience during the first year of follow‐up in a randomized clinical trial in older women and to determine the associations between various baseline characteristics and risk of SMD. DESIGH, SETTING, AND PARTICIPANTS: The authors studied 6459 postmenopausal women aged 55 to 80 from 11 clinical settings during their first year of participation in the Fracture Intervention Trial (FIT). This trial was designed to test the efficacy of alendronate (Fosamax) on fracture prevention among women with low bone mass. RESULTS: Study medication discontinuation was greatest in the first month post‐randomization (2.2%) and declined thereafter. Cumulative rates of study medication discontinuation were 4.8% (n = 311) at 3 months and 11.1% (n = 717) at 12 months. SMD was not associated with age, marital status, alcohol consumption, regular exercise, past estrogen replacement therapy use, bone mineral density, or personal or maternal fracture history. After adjusting for covariates and markers of comorbidity, the strongest predictor of SMD was fair‐to‐poor self‐rated health (relative risk (RR) 2.10; 95% confidence interval (CI) 1.47, 2.99). Having four or more depressive symptoms was also a significant predictor and had a risk associated with SMD (RR vs none 1.34; 95% CI 1.05, 1.71) similar to that seen for individuals with good self‐rated health (RR 1.49; 95% CI 1.16, 1.91). CONCLUSIONS: Results from this cohort emphasize that clinical trials in older women with multiple concomitant conditions can achieve high levels of adherence. Thought should be given to measuring self‐rated health and depressive symptoms before randomization to help identify individuals to be targeted for special assistance programs that focus on encouraging adherence.
Bibliography:	ark:/67375/WNG-NJ7RPDLS-4 istex:7DB8F5A52DB234ECB0789ED7EA59D61E48E8ECB2 ArticleID:JGS4790 ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	0002-8614 1532-5415
DOI:	10.1111/j.1532-5415.2000.tb04790.x