title: An open-label extension study of alendronate treatment in elderly women with osteoporosis.
abstract: We have recently reported the results of a 24-month, double-blind, placebo-controlled study in 359 elderly osteoporotic women who were treated with daily oral alendronate (ALN) 1, 2.5, or 5 mg or placebo (PBO). We report the results of a 12-month, open-label, extension study during which 246 patients from the original study were treated with ALN 10 mg/day. Significant increases in lumbar spine bone mineral density (BMD) were observed in patients who had previously received PBO or ALN 1 and 2.5 mg/day for 24 months. Significant gains in trochanter BMD were seen in all treatment groups. Small changes were observed in femoral neck, total body, and forearm BMD during the course of this extension study. In general, the greatest increases in BMD during the open-label extension year occurred in patients who received either PBO or the lower doses of ALN during the previous 2-year blinded study. The frequencies of all categories of upper gastrointestinal adverse experiences (AEs) were less during months 25-36 (open-label extension) than during months 0-24 (original study). In conclusion, treatment with ALN 10 mg/day for 12 months in elderly women with osteoporosis who were previously treated for 24 months with PBO or ALN 1, 2.5, or 5 mg/day increased or maintained BMD of the spine, trochanter, and forearm, and was generally safe and well tolerated, especially in the upper gastrointestinal tract.
authors.affiliation: Division of Endocrinology and Metabolism, The Medical College of Virginia at Virginia Commonwealth University, Richmond, Virginia 23298, USA.
authors.forename: R W
authors.initials: RW
authors.lastname: Downs
authors.forename: H G
authors.initials: HG
authors.lastname: Bone
authors.forename: H
authors.initials: H
authors.lastname: McIlwain
authors.forename: M Z
authors.initials: MZ
authors.lastname: Baker
authors.forename: A J
authors.initials: AJ
authors.lastname: Yates
authors.forename: A
authors.initials: A
authors.lastname: Lombardi
authors.forename: D
authors.initials: D
authors.lastname: Krupa
authors.forename: R
authors.initials: R
authors.lastname: Harning
mesh_terms: D015502:Absorptiometry, Photon; D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D019386:Alendronate / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015519:Bone Density / Q000187:drug effects; D004305:Dose-Response Relationship, Drug; D005260:Female; D005269:Femur / Q000000981:diagnostic imaging / Q000187:drug effects; D005272:Femur Neck / Q000000981:diagnostic imaging / Q000187:drug effects; D005598:Fractures, Spontaneous / Q000517:prevention & control; D005756:Gastritis / Q000139:chemically induced; D006801:Humans; D008159:Lumbar Vertebrae / Q000000981:diagnostic imaging / Q000187:drug effects; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy*; D011884:Radius / Q000000981:diagnostic imaging / Q000187:drug effects; D016896:Treatment Outcome; D014457:Ulna / Q000000981:diagnostic imaging / Q000187:drug effects
chemical_list: D019386:Alendronate