title: Effect of monitoring bone turnover markers on persistence with risedronate treatment of postmenopausal osteoporosis.
abstract: BACKGROUND
  Persistence with osteoporosis treatment is poor but is important for maximum benefit.
  
  
  OBJECTIVE
  The objective of the study was to assess the impact of physician reinforcement using bone turnover markers (BTMs) on persistence with risedronate treatment.
  
  
  METHODS
  This was a 1-yr multinational prospective, open-label, blinded study in 171 osteoporosis centers in 21 countries.
  
  
  METHODS
  A total of 2382 postmenopausal women (65-80 yr old) with spine/hip T-score -2.5 or less or T-score -1.0 or less with a low-trauma fracture.
  
  
  METHODS
  Intervention included calcium 500 mg/d, vitamin D 400 IU/d, and risedronate 5 mg/d for 1 yr. Centers were randomized to reinforcement (RE+) or no reinforcement (RE-). At 13 and 25 wk, reinforcement based on urinary N-telopeptide of type I collagen change from baseline was provided to the RE+ patients using the following response categories: good (>30% decrease), stable (-30% to +30% change), or poor (>30% increase).
  
  
  METHODS
  Persistence assessed with electronic drug monitors was measured.
  
  
  RESULTS
  In the overall efficacy population (n=2302), persistence was unexpectedly high and was similar for both groups (RE-, 77%; RE+, 80%; P=0.160). A significant relationship between the type of message and persistence was observed (P=0.017). Compared with RE-, intervention based on a good BTM response was associated with a significant improvement in persistence [hazard ratio (HR) 0.71; 95% confidence interval (CI) 0.53-0.95]. Persistence was unchanged (HR 1.02; 95% CI 0.74-1.40) or lower (HR 2.22; 95% CI 1.27-3.89) when reinforcement was based on a stable or poor BTM response, respectively. Reinforcement was associated with a lower incidence of new radiologically determined vertebral fractures (odds ratio 0.4; 95% CI, 0.2-1.0).
  
  
  CONCLUSIONS
  Reinforcement using BTMs influences persistence with treatment in postmenopausal women with osteoporosis, depending on the BTM response observed.
authors.affiliation: Institut National de la Santé et de la Recherche Médicale Research Unit 403 and University Claude Bernard, Hôpital Edouard Herriot, Pavillon F, 69437 Lyon Cedex 03, France. delmas@lyon.inserm.fr
authors.forename: Pierre D
authors.initials: PD
authors.lastname: Delmas
authors.forename: Bernard
authors.initials: B
authors.lastname: Vrijens
authors.forename: Richard
authors.initials: R
authors.lastname: Eastell
authors.forename: Christian
authors.initials: C
authors.lastname: Roux
authors.forename: Huibert A P
authors.initials: HA
authors.lastname: Pols
authors.forename: Johann D
authors.initials: JD
authors.lastname: Ringe
authors.forename: Andreas
authors.initials: A
authors.lastname: Grauer
authors.forename: David
authors.initials: D
authors.lastname: Cahall
authors.forename: Nelson B
authors.initials: NB
authors.lastname: Watts
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015415:Biomarkers / Q000097:blood; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D001842:Bone and Bones / Q000378:metabolism*; D012968:Etidronic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008991:Monitoring, Physiologic / Q000379:methods; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy*; D010349:Patient Compliance; D011446:Prospective Studies; D000068296:Risedronic Acid; D016312:Treatment Refusal
chemical_list: D015415:Biomarkers; D050071:Bone Density Conservation Agents; D000068296:Risedronic Acid; D012968:Etidronic Acid