Osteoporotic fractures can result in significant health complications and an increased risk of death. Registry studies could provide better treatment options and improve patient outcomes by providing useful information about the dis- ease. The present study describes the protocol for an osteoporosis registry in Iran. Materials and methods This registry is a prospective multicenter cohort study recruiting patients with osteoporosis from Iran. The inclusion criteria of the study are individuals diagnosed with primary or secondary osteoporosis according to the diagnostic criteria of the study; patients will be identified and recruited from outpatient clinics in this registry. All patients diagnosed with primary or secondary osteoporosis are the target population of the study. Our expected sample size is 1000 participants and the study will continue for at least 2 years. The measurements of the Iranian Osteoporosis Registry include four parts: (i) variables measured by the specific questionnaires package, (ii) bone mineral density (BMD, (iii) clinical exam- ination, and (iv) lab data. The final questionnaire package includes “demographics information”, “socioeconomic status”, “lifestyle”, “reproductive health”, “medical history and medication”, “Osteoporosis diagnosis gap”, “Osteoporosis adher- ence and treatment gap”, “fracture history and fall risk assessment”, “FRAX ® tool ”, “hospitalization and death outcomes”, “low back pain”, “hospitalization history”, “attitude toward osteoporosis”, “osteoporosis awareness”, “osteoporosis related- performance”, “quality of life (Iranian version of SF12 questionnaire )”, and “food frequency questionnaire (FFQ)”. Clinical examination of this registry includes anthropometric measurements (including height, weight, body mass index (BMI), waist circumference, hip circumference, and right wrist circumference), and blood pressure. The baseline questionnaires will be filled out right after patients are diagnosed with osteoporosis and then osteoporotic patients will be followed up regularly on a yearly basis. In the follow-up visit, variables that may have changed over time are updated. The main outcomes include registration of fall, fracture, hospitalization, medication adherence, and death. An online web-based user-friendly software is also developed for data collection. Data analysis will be conducted with the collaboration of data-mining experts and epide- miologists at the end of each follow-up.
