title: A novel monthly dosing regimen of risedronate for the treatment of postmenopausal osteoporosis: 2-year data.
abstract: This 2-year trial evaluated the efficacy and tolerability of a monthly oral regimen of risedronate. Postmenopausal women with osteoporosis were randomly assigned to double-blind treatment with risedronate 75 mg on 2 consecutive days each month (2CDM) or 5 mg daily. The primary end point was the percentage change from baseline in lumbar spine bone mineral density (BMD) at 12 months. Secondary end points included the change in BMD of the lumbar spine and proximal femur and in bone turnover markers as well as the number of subjects with at least one new vertebral fracture over 24 months. Among 1,229 patients who were randomized and received at least one dose of risedronate, lumbar spine BMD was increased in both treatment groups: mean percentage change from baseline was 4.2 ± 0.19 and 4.3 ± 0.19 % in the 75 mg 2CDM and 5 mg daily groups, respectively, at month 24. The treatment difference was 0.17 (95 % confidence interval -0.35 to 0.68). There were no statistically significant differences between treatment groups on any secondary efficacy parameters. Both treatment regimens were well tolerated. Risedronate 75 mg 2CDM was noninferior in BMD efficacy and did not show a difference in tolerability compared to 5 mg daily after 24 months of treatment in women with postmenopausal osteoporosis. This monthly regimen may provide a more convenient dosing schedule to some patients with postmenopausal osteoporosis.
authors.affiliation: Oregon Osteoporosis Center, 5050 NE Hoyt Street, Suite 626, Portland, OR 97213, USA. mmcclung@orost.com
authors.forename: Michael R
authors.initials: MR
authors.lastname: McClung
authors.forename: Claude-Laurent
authors.initials: CL
authors.lastname: Benhamou
authors.forename: Zulema
authors.initials: Z
authors.lastname: Man
authors.forename: Witold
authors.initials: W
authors.lastname: Tlustochowicz
authors.forename: Jose R
authors.initials: JR
authors.lastname: Zanchetta
authors.forename: Rachelle
authors.initials: R
authors.lastname: Eusebio
authors.forename: Ana M
authors.initials: AM
authors.lastname: Balske
authors.forename: Ellen
authors.initials: E
authors.lastname: Matzkin
authors.forename: Wojciech P
authors.initials: WP
authors.lastname: Olszynski
authors.forename: Robert
authors.initials: R
authors.lastname: Recker
authors.forename: Pierre D
authors.initials: PD
authors.lastname: Delmas
mesh_terms: D000368:Aged; D015519:Bone Density / Q000187:drug effects; D050071:Bone Density Conservation Agents / Q000008:administration & dosage*; D001842:Bone and Bones / Q000187:drug effects; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D012968:Etidronic Acid / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D008159:Lumbar Vertebrae / Q000187:drug effects; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy*; D061214:Patient Safety; D012107:Research Design; D000068296:Risedronic Acid; D016103:Spinal Fractures / Q000517:prevention & control; D016896:Treatment Outcome
chemical_list: D050071:Bone Density Conservation Agents; D000068296:Risedronic Acid; D012968:Etidronic Acid