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

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, Robert R. Recker

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22 Citations (Scopus)

Abstract

Summary 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. Introduction We 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. Methods Women with postmenopausal osteoporosis were randomly assigned to receive risedronate 5 mg immediaterelease (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. Results Two 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. Conclusions Risedronate 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.

Original languageEnglish
Pages (from-to)267-276
Number of pages10
JournalOsteoporosis International
Volume23
Issue number1
DOIs
StatePublished - Jan 2012

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Tablets
Breakfast
Safety
Bone Density
Bone Remodeling
Diphosphonates
Risedronate Sodium
Pelvic Bones
Postmenopausal Osteoporosis
Spine
Research Personnel
Incidence
Therapeutics

All Science Journal Classification (ASJC) codes

  • Endocrinology, Diabetes and Metabolism

Cite this

McClung, M. R., Miller, P. D., Brown, J. P., Zanchetta, J., Bolognese, M. A., Benhamou, C. L., ... Recker, R. R. (2012). Efficacy and safety of a novel delayed-release risedronate 35 mg once-a-week tablet. Osteoporosis International, 23(1), 267-276. https://doi.org/10.1007/s00198-011-1791-y

Efficacy and safety of a novel delayed-release risedronate 35 mg once-a-week tablet. / McClung, M. R.; Miller, P. D.; Brown, J. P.; Zanchetta, J.; Bolognese, M. A.; Benhamou, C. L.; Balske, A.; Burgio, D. E.; Sarley, J.; McCullough, L. K.; Recker, Robert R.

In: Osteoporosis International, Vol. 23, No. 1, 01.2012, p. 267-276.

Research output: Contribution to journalArticle

McClung, MR, Miller, PD, Brown, JP, Zanchetta, J, Bolognese, MA, Benhamou, CL, Balske, A, Burgio, DE, Sarley, J, McCullough, LK & Recker, RR 2012, 'Efficacy and safety of a novel delayed-release risedronate 35 mg once-a-week tablet', Osteoporosis International, vol. 23, no. 1, pp. 267-276. https://doi.org/10.1007/s00198-011-1791-y
McClung MR, Miller PD, Brown JP, Zanchetta J, Bolognese MA, Benhamou CL et al. Efficacy and safety of a novel delayed-release risedronate 35 mg once-a-week tablet. Osteoporosis International. 2012 Jan;23(1):267-276. https://doi.org/10.1007/s00198-011-1791-y
McClung, M. R. ; Miller, P. D. ; Brown, J. P. ; Zanchetta, J. ; Bolognese, M. A. ; Benhamou, C. L. ; Balske, A. ; Burgio, D. E. ; Sarley, J. ; McCullough, L. K. ; Recker, Robert R. / Efficacy and safety of a novel delayed-release risedronate 35 mg once-a-week tablet. In: Osteoporosis International. 2012 ; Vol. 23, No. 1. pp. 267-276.
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abstract = "Summary 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. Introduction We 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. Methods Women with postmenopausal osteoporosis were randomly assigned to receive risedronate 5 mg immediaterelease (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. Results Two 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. Conclusions Risedronate 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.",
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AU - Bolognese, M. A.

AU - Benhamou, C. L.

AU - Balske, A.

AU - Burgio, D. E.

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N2 - Summary 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. Introduction We 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. Methods Women with postmenopausal osteoporosis were randomly assigned to receive risedronate 5 mg immediaterelease (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. Results Two 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. Conclusions Risedronate 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.

AB - Summary 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. Introduction We 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. Methods Women with postmenopausal osteoporosis were randomly assigned to receive risedronate 5 mg immediaterelease (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. Results Two 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. Conclusions Risedronate 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.

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