Efficacy and safety of a novel delayed-release risedronate 35 mg once-a-week tablet View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2011-09-27

AUTHORS

M. R. McClung, P. D. Miller, J. P. Brown, J. Zanchetta, M. A. Bolognese, C. L. Benhamou, A. Balske, D. E. Burgio, J. Sarley, L. K. McCullough, R. R. Recker

ABSTRACT

Dosing regimens of oral bisphosphonates are inconvenient and contribute to poor compliance. The bone mineral density response to a once weekly delayed-release formulation of risedronate given before or following breakfast was non-inferior to traditional immediate-release risedronate given daily before breakfast. Delayed-release risedronate is a convenient regimen for oral bisphosphonate therapy.IntroductionWe report the results of a randomized, controlled, clinical study assessing the efficacy and safety of a delayed-release (DR) 35 mg weekly oral formulation of risedronate that allows patients to take their weekly risedronate dose before or immediately after breakfast.MethodsWomen with postmenopausal osteoporosis were randomly assigned to receive risedronate 5 mg immediate-release (IR) daily (n = 307) at least 30 min before breakfast, or risedronate 35 mg DR weekly, either at least 30 min before breakfast (BB, n = 308) or immediately following breakfast (FB, n = 307). Bone mineral density (BMD), bone turnover markers (BTMs), fractures, and adverse events were evaluated. The primary efficacy variable was percent change from baseline in lumbar spine BMD at Endpoint.ResultsTwo hundred fifty-seven subjects (83.7%) in the IR daily group, 252 subjects (82.1%) in the DR FB weekly group, and 258 subjects (83.8%) in the DR BB weekly group completed 1 year. Both DR weekly groups were determined to be non-inferior to the IR daily regimen. Mean percent changes in hip BMD were similar across groups. The magnitude of BTM response was similar across groups; some statistical differences were seen that were small and deemed by investigators to have no major clinical importance. The incidence of adverse events leading to withdrawal and serious adverse events were similar across treatment groups. All three regimens were well tolerated.ConclusionsRisedronate 35 mg DR weekly is similar in efficacy and safety to risedronate 5 mg IR daily, and will allow patients to take their weekly risedronate dose immediately after breakfast. More... »

PAGES

267-276

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00198-011-1791-y

DOI

http://dx.doi.org/10.1007/s00198-011-1791-y

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1040344660

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/21947137


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81 oral formulation
82 osteoporosis
83 patients
84 percent change
85 poor compliance
86 postmenopausal osteoporosis
87 primary efficacy variable
88 regimen
89 regimens
90 response
91 results
92 risedronate
93 risedronate 35
94 risedronate 5
95 safety
96 serious adverse events
97 spine bone mineral density
98 statistical difference
99 study
100 subjects
101 tablets
102 therapy
103 treatment groups
104 turnover markers
105 variables
106 weekly
107 weekly group
108 withdrawal
109 years
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