title: Alendronate/vitamin D3 70 mg/2800 IU with and without additional 2800 IU vitamin D3 for osteoporosis: results from the 24-week extension of a 15-week randomized, controlled trial.
abstract: Although vitamin D supplementation is a fundamental part of osteoporosis treatment, many patients do not regularly take adequate amounts. A once-weekly (OW) alendronate (ALN) preparation that includes 2800 IU of vitamin D3 in a single combination tablet (ALN+D2800) is available for treating patients and ensuring intake of vitamin D that is consistent with existing guidelines. This randomized, double-blind study extension was conducted to evaluate the safety and tolerability of ALN+D2800 and ALN+D2800 plus an additional 2800 IU vitamin D3 single tablet supplement (ALN+D5600) administered for 24 weeks in men and postmenopausal women with osteoporosis previously treated OW for 15 weeks with either ALN or ALN+D2800. The primary endpoint was the proportion of participants who developed hypercalciuria (defined as a 24-hour urine calcium >300 mg in women or >350 mg in men and an increase of >25% versus randomization baseline) at week 39. The key secondary endpoint was the proportion of participants with vitamin D insufficiency (serum 25(OH)D <15 ng/mL [37.4 nmol/L]) at the end of the study. Hypercalciuria incidence (4.2% [ALN+D5600] vs. 2.8% [ALN+D2800]), did not differ between groups (p = 0.354). No participants developed hypercalcemia. Among the participants with vitamin D insufficiency at the week 0 baseline, the prevalence of insufficiency at the end of the study was reduced by 92% in the ALN+D5600 group and by 86% in the ALN+D2800 group. The incidences of clinical adverse experiences, including drug-related adverse experiences, were similar in both groups. In subjects previously treated with ALN+D2800 for 15 weeks, the addition of 2800 IU D3 for 24 weeks did not produce hypercalcemia nor increase the risk of hypercalciuria.
authors.affiliation: University of Wisconsin-Madison, Osteoporosis Clinical Center and Research Program, 2870 University Avenue, Suite 100, Madison, WI 53705, USA. nbinkley@wisc.edu
authors.forename: Neil
authors.initials: N
authors.lastname: Binkley
authors.forename: Johann D
authors.initials: JD
authors.lastname: Ringe
authors.forename: John I
authors.initials: JI
authors.lastname: Reed
authors.forename: Osten
authors.initials: O
authors.lastname: Ljunggren
authors.forename: Michael F
authors.initials: MF
authors.lastname: Holick
authors.forename: Helmut W
authors.initials: HW
authors.lastname: Minne
authors.forename: Minzhi
authors.initials: M
authors.lastname: Liu
authors.forename: Amy
authors.initials: A
authors.lastname: Lamotta
authors.forename: Joseph A
authors.initials: JA
authors.lastname: West
authors.forename: Arthur C
authors.initials: AC
authors.lastname: Santora
mesh_terms: D000368:Aged; D019386:Alendronate / Q000008:administration & dosage* / Q000009:adverse effects; D015519:Bone Density; D050071:Bone Density Conservation Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002762:Cholecalciferol / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D053565:Hypercalciuria / Q000139:chemically induced* / Q000453:epidemiology; D008297:Male; D010024:Osteoporosis / Q000188:drug therapy*; D017698:Postmenopause
chemical_list: D050071:Bone Density Conservation Agents; D002762:Cholecalciferol; D019386:Alendronate