title: Efficacy and safety of a novel delayed-release risedronate 35 mg once-a-week tablet.
abstract: Dosing regimens of oral bisphosphonates are inconvenient and contribute to poor compliance. The bone mineral density response to a once weekly delayed-release formulation of risedronate given before or following breakfast was non-inferior to traditional immediate-release risedronate given daily before breakfast. Delayed-release risedronate is a convenient regimen for oral bisphosphonate therapy.
  
  
  BACKGROUND
  We report the results of a randomized, controlled, clinical study assessing the efficacy and safety of a delayed-release (DR) 35 mg weekly oral formulation of risedronate that allows patients to take their weekly risedronate dose before or immediately after breakfast.
  
  
  METHODS
  Women with postmenopausal osteoporosis were randomly assigned to receive risedronate 5 mg immediate-release (IR) daily (n = 307) at least 30 min before breakfast, or risedronate 35 mg DR weekly, either at least 30 min before breakfast (BB, n = 308) or immediately following breakfast (FB, n = 307). Bone mineral density (BMD), bone turnover markers (BTMs), fractures, and adverse events were evaluated. The primary efficacy variable was percent change from baseline in lumbar spine BMD at Endpoint.
  
  
  RESULTS
  Two hundred fifty-seven subjects (83.7%) in the IR daily group, 252 subjects (82.1%) in the DR FB weekly group, and 258 subjects (83.8%) in the DR BB weekly group completed 1 year. Both DR weekly groups were determined to be non-inferior to the IR daily regimen. Mean percent changes in hip BMD were similar across groups. The magnitude of BTM response was similar across groups; some statistical differences were seen that were small and deemed by investigators to have no major clinical importance. The incidence of adverse events leading to withdrawal and serious adverse events were similar across treatment groups. All three regimens were well tolerated.
  
  
  CONCLUSIONS
  Risedronate 35 mg DR weekly is similar in efficacy and safety to risedronate 5 mg IR daily, and will allow patients to take their weekly risedronate dose immediately after breakfast.
authors.affiliation: Oregon Osteoporosis Center, 5050 NE Hoyt, Suite 626, Portland, OR 97213, USA. mmcclung@orost.com
authors.forename: M R
authors.initials: MR
authors.lastname: McClung
authors.forename: P D
authors.initials: PD
authors.lastname: Miller
authors.forename: J P
authors.initials: JP
authors.lastname: Brown
authors.forename: J
authors.initials: J
authors.lastname: Zanchetta
authors.forename: M A
authors.initials: MA
authors.lastname: Bolognese
authors.forename: C L
authors.initials: CL
authors.lastname: Benhamou
authors.forename: A
authors.initials: A
authors.lastname: Balske
authors.forename: D E
authors.initials: DE
authors.lastname: Burgio
authors.forename: J
authors.initials: J
authors.lastname: Sarley
authors.forename: L K
authors.initials: LK
authors.lastname: McCullough
authors.forename: R R
authors.initials: RR
authors.lastname: Recker
mesh_terms: D000284:Administration, Oral; D000368:Aged; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D012968:Etidronic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005269:Femur / Q000503:physiopathology; D006801:Humans; D008159:Lumbar Vertebrae / Q000503:physiopathology; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy* / Q000503:physiopathology; D000068296:Risedronic Acid; D013608:Tablets, Enteric-Coated; D016896:Treatment Outcome
chemical_list: D050071:Bone Density Conservation Agents; D003692:Delayed-Action Preparations; D013608:Tablets, Enteric-Coated; D000068296:Risedronic Acid; D012968:Etidronic Acid