Design and baseline characteristics of the osteoporotic fractures in men (MrOS) study--a large observational study of the determinants of fracture in older men.

Very little information is available to direct the prevention or management of osteoporosis in men. The Osteoporotic Fractures in Men (MrOS) Study is a prospective cohort study designed to examine the extent to which fracture risk is related to bone mass, bone geometry, lifestyle, anthropometric and neuromuscular measures, and fall propensity, as well as to determine how fractures affect quality of life in men. The study is also designed to understand how osteoporosis is related to prostate disease. At baseline, participants completed questionnaires regarding medical history, medications, physical activity, diet, alcohol intake, and cigarette smoking. Objective measures of anthropometric, neuromuscular, vision, strength, and cognitive variables were obtained. Skeletal assessments included DEXA, calcaneal ultrasound, and vertebral radiographs. Vertebral and proximal femoral QCT was performed on a subset (65%). Serum, urine, and DNA specimens were collected. After the baseline assessments, a questionnaire is mailed to participants every 4 months to ascertain incident falls, fractures, prostate cancer, and deaths. After an average of 4.5 years, participants are scheduled to return for a second comprehensive visit. Men were eligible if > or =65 years. 5995 men enrolled with a mean (+/-SD) age of 73.7 (+/-5.9) years, 11% of which were minorities. Most rated their health as good/excellent. Few were current smokers, although 59% had smoked previously, and 35% reported no alcohol intake, while 47% consumed at least 2 drinks per week. The mean (range) body mass index was 26.9 kg/m2 (17-56). A non-traumatic fracture after age 50 was reported by 17% of the cohort. The MrOS cohort should provide valuable information concerning the determinants of fracture in men and should help set the stage for the development of effective methods to identify those at risk.

Overview of recruitment for the osteoporotic fractures in men study (MrOS).

Large, long term research studies present recruitment challenges that can be met with collaborative approaches to identify and enroll participants. The Osteoporotic Fractures in Men Study (MrOS), a multi-center observational study designed to determine risk factors for osteoporosis, fractures and prostate cancer in older men, recruited 5995 participants over a 25-month period. Enrolling a cohort that represented the race and age distribution of each community, and developing interest in an older male cohort about a condition commonly thought of as a "women's disease," were major recruitment challenges. During the start-up phase, recruitment challenges and strategies were analyzed and collective approaches were developed to address ways to motivate the target population. Key methods included mailings using community and provider contact lists; regional and senior newspaper advertisements; and presentations targeted to seniors. Sites used a centrally developed recruitment brochure. Response to mass mailings at some sites surpassed 10-15% and appointment show rates averaged above 85%. The final number enrolled in MrOS was 5% more than the original recruitment goal of 5700. Minority recruitment was enhanced through the use of the Health Care Financing Administration and other databases that allowed for targeted recruitment. Overall, minority enrollment was approximately 10.56% of the cohort (244 African American, 191 Asian). Men age>80 were enthusiastic and represent about 18% of enrollees. Through a coordinated approach of developing and refining recruitment strategies and materials, sites were able to adapt their original strategies and complete recruitment ahead of schedule.