title: The efficacy and tolerability of risedronate once a week for the treatment of postmenopausal osteoporosis.
abstract: This study evaluated the efficacy and tolerability of risedronate once a week (35 mg and 50 mg) compared with risedronate 5 mg once daily in women with osteoporosis. We conducted a randomized, double-blind, active-controlled, 2-year study; the primary efficacy assessment was performed after 1 year. Subjects were women aged 50 years or older who had been postmenopausal for at least 5 years, with either a bone mineral density (BMD) T-score of -2.5 or lower (lumbar spine or proximal femur) or a T-score lower than -2 and at least one prevalent vertebral fracture. Subjects received risedronate 5 mg once daily, 35 mg once a week or 50 mg once a week. All subjects also received 1 g daily of elemental calcium supplementation and supplemental vitamin D if the baseline serum levels were low. The primary efficacy measure was percent change in lumbar spine BMD at 12 months. A total of 1,456 women were randomized and received medication; 1,209 (83%) women completed 12 months. The mean percent change (SE) in lumbar spine BMD after 12 months was 4.0% (0.2%) in the 5 mg daily group, 3.9% (0.2%) in the 35 mg group, and 4.2% (0.2%) in the 50 mg group; each once-a-week treatment was determined to be as effective as the daily treatment. Outcomes of the secondary efficacy measurements and safety assessments were also similar in all 3 groups after 12 months. Risedronate 35 mg and 50 mg once a week provide the same efficacy and safety as the daily 5 mg regimen; therefore, the lower dose, 35 mg once a week, is considered optimal for women with postmenopausal osteoporosis who desire a once-a-week regimen.
authors.affiliation: Le Centre de recherche du CHUL, Laval University, Sainte-Foy, Québec, Canada. Jacques.Brown@crchul.ulaval.ca
authors.forename: J P
authors.initials: JP
authors.lastname: Brown
authors.forename: D L
authors.initials: DL
authors.lastname: Kendler
authors.forename: M R
authors.initials: MR
authors.lastname: McClung
authors.forename: R D
authors.initials: RD
authors.lastname: Emkey
authors.forename: J D
authors.initials: JD
authors.lastname: Adachi
authors.forename: M A
authors.initials: MA
authors.lastname: Bolognese
authors.forename: Z
authors.initials: Z
authors.lastname: Li
authors.forename: A
authors.initials: A
authors.lastname: Balske
authors.forename: R
authors.initials: R
authors.lastname: Lindsay
mesh_terms: D000284:Administration, Oral; D000368:Aged; D015415:Biomarkers / Q000032:analysis; D015519:Bone Density; D001862:Bone Resorption / Q000378:metabolism; D002121:Calcium Channel Blockers / Q000008:administration & dosage / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D012968:Etidronic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D005260:Female; D005272:Femur Neck / Q000187:drug effects / Q000378:metabolism; D006801:Humans; D008159:Lumbar Vertebrae / Q000187:drug effects / Q000378:metabolism; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy* / Q000378:metabolism; D000068296:Risedronic Acid; D016103:Spinal Fractures / Q000517:prevention & control; D013270:Stomach / Q000187:drug effects / Q000473:pathology; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D002121:Calcium Channel Blockers; D000068296:Risedronic Acid; D012968:Etidronic Acid