title: Medication Use Patterns, Treatment Satisfaction, and Inadequate Control of Osteoporosis Study in the Asia-Pacific Region (MUSIC OS-AP): Design of a multinational, prospective, observational study examining the impact of gastrointestinal events on osteoporosis management in postmenopausal women.
abstract: BACKGROUND
  The burden of osteoporosis in the Asia-Pacific region is not well characterized. The Medication Use Patterns, Treatment Satisfaction, and Inadequate Control of Osteoporosis Study in the Asia-Pacific Region (MUSIC OS-AP) was designed to better understand the association of gastrointestinal events with patient-reported outcomes in postmenopausal women of this region.
  
  
  METHODS
  MUSIC OS-AP is a prospective, multinational, observational cohort study of postmenopausal women ≥ 50 years of age diagnosed with osteoporosis. The study was conducted in five Asia-Pacific countries: Australia, New Zealand, Taiwan, Korea, and India. MUSIC OS-AP has three components: a physician questionnaire, a retrospective chart review, and a prospective cohort study. The physician questionnaire investigated the role of gastrointestinal events in physicians' pharmacologic management of osteoporosis. The retrospective chart review, also completed by physicians, recorded rate of osteoporosis treatment and the types of osteoporosis medications prescribed to osteoporosis patients. The prospective cohort study investigated the associations between gastrointestinal events and patient-reported outcomes among patients taking oral medications for osteoporosis as well as reasons for non-treatment in patients who remained untreated. The prospective cohort study enrolled two groups of patients: untreated, and treated with oral osteoporosis medications. Untreated patients completed only the baseline surveys, providing information on gastrointestinal event rates, quality of life, health care resource use, and reasons for non-treatment. Treated patients, who were either new to osteoporosis medication or continuing an ongoing medication course, completed surveys at baseline and 3, 6, and 12 months post-baseline. The evaluations recorded patient characteristics, gastrointestinal events, health-related and osteoporosis-specific quality of life, health care resource use, medication adherence, and satisfaction with treatment.
  
  
  RESULTS
  Physicians at 59 sites completed the physician questionnaire, and data for 300 patients from 26 sites were abstracted for the retrospective chart review. Enrollment and baseline data collection for the prospective cohort study were conducted between July 2013 and August 2014 for 301 untreated and 3287 treated patients, of whom 1416 were new users and 1871 were experienced users of oral osteoporosis medications.
  
  
  CONCLUSIONS
  The results of MUSIC OS-AP will highlight the association of gastrointestinal events with patient-reported outcomes among postmenopausal women with osteoporosis and elucidate physicians' management of gastrointestinal events among this patient population in the Asia-Pacific region.
authors.affiliation: Center for Observational and Real-World Evidence, Merck & Co., Inc., Kenilworth, NJ, USA.
authors.forename: Ankita
authors.initials: A
authors.lastname: Modi
authors.affiliation: Monash University, Clayton, Australia.
authors.forename: Peter R
authors.initials: PR
authors.lastname: Ebeling
authors.affiliation: Kaohisung Chang Gung Memorial Hospital, Chang Gung University, Taiwan.
authors.forename: Mel S
authors.initials: MS
authors.lastname: Lee
authors.affiliation: Sungkyunkwan University, Jongno-gu, Seoul, South Korea.
authors.forename: Yong-Ki
authors.initials: YK
authors.lastname: Min
authors.affiliation: Medanta the Medicity, Gurgaon, Haryana, India.
authors.forename: Ambrish
authors.initials: A
authors.lastname: Mithal
authors.affiliation: Center for Observational and Real-World Evidence, Merck & Co., Inc., Kenilworth, NJ, USA.
authors.forename: Xiaoqin
authors.initials: X
authors.lastname: Yang
authors.affiliation: Center for Observational and Real-World Evidence, Merck & Co., Inc., Kenilworth, NJ, USA.
authors.forename: Shiva
authors.initials: S
authors.lastname: Sajjan
keywords: ADEOS, Adherence Evaluation of Osteoporosis treatment; BMD, bone mineral density; EQ-5D-3L, European Quality of Life-5 Dimensions; GI, gastrointestinal; Gastrointestinal diseases; MUSIC-OS, Medication Use Patterns, Treatment Satisfaction, and Inadequate Control of Osteoporosis Study; Medication adherence; OPAQ-SV, Osteoporosis Assessment Questionnaire; OPSAT-Q, Osteoporosis Patient Satisfaction Questionnaire; Osteoporosis; Patient satisfaction; Postmenopausal; Quality of life; Research design