title: Japan Fracture Observational Study (JFOS): patient characteristics and interim data on the use of daily teriparatide in Japanese patients with osteoporosis.
abstract: OBJECTIVE
  This report from the Japan Fracture Observational Study (JFOS) describes the design of the study, baseline characteristics of the patients, and interim results.
  
  
  METHODS
  This is an interim analysis from an ongoing observational study of male and female patients with osteoporosis initiating daily teriparatide treatment observed at baseline, 3, 6 and 12 months. There was no control group. Baseline data were collected on demographic characteristics, medical and osteoporosis history, prior use of medications and health-related quality of life (HRQoL). This interim analysis includes preliminary information concerning incidence of clinical fractures, bone mineral density (BMD), procollagen type 1 aminoterminal propeptide (P1NP), back pain, HRQoL, and adverse events.
  
  
  RESULTS
  Baseline observations were completed for 1810 patients; 90.1% were female. Compared with osteoporotic patients treated with teriparatide in other observational studies, those in JFOS were older but had fewer osteoporosis risk factors. The incidence of clinical fractures was 2.9% at 6 months and 3.7% at 12 months. At 12 months, mean BMD was 8.9% higher at the lumbar spine and 0.8% higher at the total hip compared to baseline. At 6 months, the median serum concentration of P1NP was 187.7% higher than at baseline. At 12 months, back pain scores assessed by visual analog scale (VAS) were lower and HRQoL scores were higher than at baseline. No new safety signals were observed.
  
  
  CONCLUSIONS
  This is the first report from an observational study of daily teriparatide in Japanese osteoporotic patients at high risk of fractures. Patients in JFOS were older but had fewer osteoporosis risk factors than those treated with teriparatide in other observational studies. The interim analysis suggests that the clinical profile of teriparatide in the real world is similar to that observed in clinical trials and observational studies conducted in Europe and the United States.
authors.affiliation: a a Department of Orthopedic Surgery and Rheumatology , Nara Hospital, Kinki University Faculty of Medicine , Ikoma City , Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Soen
authors.affiliation: b b Health Management and Promotion Center, Hiroshima Atomic Bomb Casualty Council , Hiroshima City , Japan.
authors.forename: Saeko
authors.initials: S
authors.lastname: Fujiwara
authors.affiliation: c c Department of Medicine and Bioregulatory Science , Graduate School of Medical Sciences, Kyushu University , Fukuoka City , Japan.
authors.forename: Ryoichi
authors.initials: R
authors.lastname: Takayanagi
authors.affiliation: d d Medicines Development Unit Japan , Eli Lilly Japan KK, Kobe City , Japan.
authors.forename: Masayo
authors.initials: M
authors.lastname: Sato
authors.affiliation: d d Medicines Development Unit Japan , Eli Lilly Japan KK, Kobe City , Japan.
authors.forename: Mika
authors.initials: M
authors.lastname: Tsujimoto
authors.affiliation: d d Medicines Development Unit Japan , Eli Lilly Japan KK, Kobe City , Japan.
authors.forename: Takanori
authors.initials: T
authors.lastname: Yamamoto
authors.affiliation: d d Medicines Development Unit Japan , Eli Lilly Japan KK, Kobe City , Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Enomoto
authors.affiliation: e e Bio-Medicines Core Team, Eli Lilly and Company , Indianapolis , IN , USA.
authors.forename: John H
authors.initials: JH
authors.lastname: Krege
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001416:Back Pain / Q000453:epidemiology / Q000209:etiology; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D050723:Fractures, Bone / Q000453:epidemiology / Q000209:etiology; D006801:Humans; D015994:Incidence; D007564:Japan / Q000453:epidemiology; D008297:Male; D010024:Osteoporosis / Q000150:complications / Q000188:drug therapy / Q000453:epidemiology / Q000378:metabolism / Q000523:psychology; D010446:Peptide Fragments / Q000097:blood; D011347:Procollagen / Q000097:blood; D011446:Prospective Studies; D011788:Quality of Life; D012307:Risk Factors; D019379:Teriparatide / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D050071:Bone Density Conservation Agents; D010446:Peptide Fragments; D011347:Procollagen; C047202:procollagen Type I N-terminal peptide; D019379:Teriparatide
keywords: Daily teriparatide; Fracture; Japanese population; Observational study; Osteoporosis; Quality of life