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PMID: 12501880 Published · ppublish English Clinical Trial Comparative Study Journal Article Multicenter Study Randomized Controlled Trial

Patient preference for once-weekly alendronate 70 mg versus once-daily alendronate 10 mg: a multicenter, randomized, open-label, crossover study.

Clinical therapeutics ·Vol. 24 ·No. 11 ·2002-11-00 ·Pages 1871-86

Simon JA, Lewiecki EM, Smith ME, Petruschke RA, Wang L, Palmisano JJ

Abstract

Alendronate, an oral bisphosphonate, is available for the treatment of osteoporosis in a 70-mg once-weekly and a 10-mg once-daily formulation. This study aimed to determine patient preference for once-weekly versus once-daily dosing with alendronate, and to determine which treatment regimen the patients believed was more convenient and would be easier to comply with for a long period. This was a multicenter, randomized, open-label, preference study in which postmenopausal women with osteoporosis were enrolled to receive 9 weeks of treatment in crossover fashion (4 weeks with each study regimen separated by a 1-week washout period). The study regimens included once-weekly alendronate 70 mg and once-daily alendronate 10 mg. The primary and secondary end points were assessed with a questionnaire completed by the patient. Adverse events (AEs) were recorded to assess patient tolerability of the study medications. A total of 324 patients met the eligibility requirements; 288 were randomized to treatment, 287 (mean age, 64.8 years) received treatment, 272 completed the questionnaire, and 266 completed the study. Of the patients who completed the questionnaire, 235 patients preferred the 70-mg once-weekly dosing regimen compared with the 10-mg once-daily regimen (86.4% vs 9.2%; P < 0.001). Most patients also believed that once-weekly dosing was more convenient than once-daily dosing (89.0% vs 7.7%; P < 0.001) and would allow them to achieve better long-term compliance (87.5% vs 8.5%; P < 0.001). Clinical AEs were reported in 30.7% of patients treated with once-weekly alendronate and 30% of patients treated with once-daily alendronate, with no significant differences between treatments. When once-weekly alendronate 70 mg was compared with once-daily alendronate 10 mg in this study, 70-mg once-weekly alendronate was the preferred dosing regimen.

MeSH Terms
Administration, Oral Adult Aged Alendronate/administration & dosage,adverse effects,therapeutic use Cross-Over Studies Female Humans Middle Aged Osteoporosis, Postmenopausal/drug therapy,physiopathology Patient Compliance Patient Satisfaction Surveys and Questionnaires United States
Chemicals
Alendronate
Authors & Affiliations
6 authors, click to expand affiliations / ORCID
Simon James A
George Washington University School of Medicine, Washington, DC, USA.
Lewiecki E Michael
Smith Mary E
Petruschke Richard A
Wang Lixia
Palmisano Joanne J
Article Info
Journal
Clinical therapeutics
Abbr.
Clin Ther
ISSN
0149-2918
Published
2002-11-00
Pages
1871-86
Language
English
Region
United States
NLM ID
7706726
Subset
IM
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