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Risedronate dosing before breakfast compared with dosing later in the day in women with postmenopausal osteoporosis

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Abstract

Summary

Two studies in postmenopausal women with osteoporosis provide information about the efficacy and safety of dosing oral risedronate 5 mg daily at a time other than before breakfast (i.e., 2 h before and 2 h after any food and drink other than plain water). A significant increase in lumbar spine BMD was observed for both treatment regimens in the two studies. However, smaller increases in lumbar spine BMD were observed with flexible dosing versus before-breakfast dosing. Geographic region, compliance, and consistency of dosing time appear to affect the amount of increase in BMD observed with flexible dosing.

Introduction

Two studies in postmenopausal women with osteoporosis provide additional information about the efficacy and safety of dosing oral risedronate 5 mg daily at a time other than before breakfast (i.e., 2 h before and 2 h after any food and drink other than plain water).

Methods

One study, flexible dosing, was a 6-month North American study in 730 patients randomized to before-breakfast dosing or flexible dosing later in the day. A second study, IMPACT, was a large (N = 2382), 1-year multinational study in patients that chose their dosing regimen (before breakfast or later in the day). These studies were used to examine the bone mineral density (BMD) response with different dosing regimens.

Results

A significant increase in lumbar spine BMD was observed for both treatment regimens in the two studies. However, in both studies, the flexible dosing group had a smaller increase from baseline compared to the before-breakfast regimen (ratio of flexible dosing to before breakfast: flexible dosing study, 0.52; IMPACT study, 0.75). In addition, a relationship between geographic region and BMD response was observed with flexible dosing in both studies. Patients in the flexible dosing group who had greater dosing compliance (based on the number of times the bottle was opened) and consistency of dosing time (bottle opened within a 1.5-h window) had a greater increase in lumbar spine BMD.

Conclusion

Results of these two studies demonstrate that overall flexible dosing of risedronate leads to smaller BMD gains compared to before-breakfast dosing. This result may be due to poorer adherence to the flexible dosing instructions that may be more pronounced in patients in certain geographic regions. If patients cannot abide by before-breakfast dosing and flexible dosing is an approved option, one can expect suboptimal BMD results with flexible dosing.

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Acknowledgments

The authors are grateful to Pamela Schofield, David Cahall, and Andreas Grauer for their technical assistance in the preparation of this manuscript. The authors wish to thank all the investigators that participated in the conduct of the flexible dosing and IMPACT studies. The principal investigators at each study center were: J. Adachi, Hamilton, ON; C. Albanese, Roma, ITA; C. Alexandre, St-Etienne, FRA; B. Allolio, Würzburg, DEU; B.H. Ascott-Evans, Cape Town, ZAF; M. Audran, Angers, FRA; G.L. Bakris, Chicago, IL; C. Bench, Salt Lake City, UT; C.L. Benhamou, Orleans, FRA; N. Binkley, Madison, WI; J. Blanch, Barcelona, ESP; E.P. Boling, Upland, CA; M.A. Bolognese, Bethesda, MD; S. Boonen, Lueven, AUT; T. Boermans, Losser, NLD; J. Brown, Sainte-Foy, QC; G. Brabant, Hannover, DEU; R. Brewer, Little Rock, AR; D. Briancon, Aix les Bains, FRA; S.B. Broy, Chicago, IL; P. Bourgeois, Paris, FRA; C. Bouvier, Tours, FRA; C. Campusano, Santiago de Chile, CHL; A. Carcassi, Sassari, ITA; G. Chales, Rennes, FRA; R. Civitelli, St. Louis, MO; S.B. Cohen, Dallas, TX; B. Combe, Montpellier, FRA; L.G. Corn, Sarasota, FL; B. Cortet, Lille, FRA; D. Cucinotta, Bologna, ITA; A. Daragon, Boisguillaume, FRA; N.R. de Melo, São Paulo, BRA; T.J. De Villiers, Cape Town, ZAF; A.J. De Weerd, Pretoria, ZAF; J. del Pino Montes, Salamanca, ESP; P. Delmas, Lyon, FRA; O. Di Munno, Pisa, ITA; H. Dobnig, Graz, AUT; R. Dore, Anaheim, CA; R. Dreher, Bad Kreuznach, DEU; R. Dumas, Laval, QC; R. Eastell, Sheffield, GBR; J. Eisman, Darlinghurst, AUS; G. Ellis, Somerset West, ZAF; W.T. Ellison, Greer, SC; R.D. Emkey, Reading, PA; S.C. English, Billings, MT; J.E. Ervin, Kansas City, MO; G. Evans, Jacksonville, FL; L. Euller-Ziegler, Nice, FRA; P. Fardellone, Amiens, FRA; J. Farrerons, Barcelona, ESP; D. Felsenberg, Berlin, DEU; C.E. Fiore, Catania, ITA; O. FitzGerald, Dublin, IRL; I. Fogelman, London, GBR; H. Francke, Oberammergau, DEU; V. Gangji, Bruxells, AUT; H. Gajardo, Santiago de Chile, CHL; R. 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Kurthen, Aachen, DEU; M. Laroche, Toulouse, FRA; M. LeBoff, Boston, MA; G. Lehmann, Jena, DEU; E. Leib, Burlington, VT; C. Libanati, Loma Linda, CA; S. Lindsey, Baton Rouge, LA; K. Lippuner, Bern, CHE; S. Lipschitz, Johannesburg, ZAF; J. Lisse, Tucson, AZ; A. Lopes Vaz, Oporto, PRT; M.M. Luckey, Livingston, NJ; P. Maier, Bad Waldsee, DEU; M. Malloy, Cork, IRL; W. Maksymowych, Edmonton, AB; R.L. Malamet, Hagerstown, MD; Z. Man, Buenos Aires, ARG; P. Masaryk, Pieštany, SVK; L. Mathy, Braine-Alleud, AUT; C. Mautalen, Buenos Aires, ARG; M. McClung, Portland, OR; H.H. McIlwain, Tampa, FL; C.D. McKeever, Houston, TX; J.M. McKenney, Richmond, VA; T.E. Melchione, Sacramento, CA; O. Messina, Buenos Aires, ARG; P.D. Miller, Denver, CO; R. Miller, Baltimore, MD; S. Miller, San Antonio, TX; H. Mönig, Kiel, DEU; A. Morales Piga, Madrid, ESP; A. Möricke, Magdeberg, DEU; E. Morris, Baltimore, MD; M. Muratore, San Cesareo, ITA; F.T. Murphy, Duncansville, PA; C. Netelenbos, Amsterdam, NLD; M.J. Noss, Cincinnati, OH; W.P. Olszynski, Saskatoon, SK; J. Orozco Alcalá, Guadalajara, MEX; S. Ortolani, Milano, ITA; E. Orwoll, Portland, OR; J.P. Ouellet, Sherbrooke, QC; G. Palummeri, Genova, ITA; F.S. Pansini, Ferrara, ITA; G. Parenti, Mariano Comense, ITA; J.E. Pappas, Lexington, KY; M. Passeri, Parma, ITA; J. Payer, Bratislava, SVK; R. Perez Cano, Sevilla, ESP; W. Petit, New Britain, CT; J. Pfeilschifter, Bochum, DEU; J. Pinkerton, Charlottesville, VA; D.A. Podlecki, Longmont, CO; H. Pols, Rotterdam, NLD; A. Porges, Hewlett, NY; E. Preisinger, Vienna, AUT; R. Prince, Nedlands, AUS; H.M. Prupas, Reno, NV; J.M. Quesada Gomez, Córdoba, ESP; H. Radspieler, München, DEU; R. Ramsey-Goldman, Chicago, IL; A. Rapado, Madrid, ESP; S. Rao, Detroit, MI; R. Recker, Omaha, NE; M. Reincke, Freiberg, DEU; H. Resch, Vienna, AUT; G.B. Rini, Palermo, ITA; R. Rizzoli, Geneva, CHE; L. Rodriguez Arboleya, Gijón, ESP; J. Rodriguez Moreno, L'Hospitalet de Llobregat, ESP; C. Roux, Paris, FRA; J Rosenstock, Dallas, TX; A. Rubinacci, Milano, ITA; P. Sambrook, St. Leonards, AUS; P. Schneider, Würzburg, DEU; H. Schwarz, Freudenstadt, DEU; E.N. Schwartz, Oakland, CA; S.L. Schwartz, San Antonio, TX; A. Sebba, Palm Harbor, FL; E. Seeman, Heidelburg, AUS; J. Seibel, Heidelberg, DEU; J. Semler, Berlin, DEU; W. Shergy, Huntsville, AL; K.G. Siminoski, Edmonton, AB; L. Sinigaglia, Milano, ITA; S. Solomon, Cherry Hill, NJ; M. Sosa, Las Palmas de Gran Canaria, ESP; L.G. Ste-Marie, Montreal, QC; J.J. Stepan, Prague, CZE; M.S. Stjernholm, Boulder, CO; H. Stracke, Geissen, DEU; V. Szejnfeld, São Paulo, BRA; S.B. Tanner, Nashville, TN; I. Testa, Ancona, ITA; A. Torrijos, Madrid, ESP; R. Trapp, USA; C. Trischitta, San Giovanni Rotondo, ITA; S. Tylavsky, Memphis, TN; W.J.R.R. Venekamp, Brunssum, NLD; A. Vilar, Lisboa, PRT; J.P.D. Wade, Vancouver, BC; N. Watts, Cincinnati, OH; R.D. Wasnick, Honolulu, HI; G. Weryha, Vandoeuvre, FRA; L. Williame, Antwerpen, AUT; L. Willis, Oklahoma City, OK; S. Wimalawansa, Galveston, TX; W. Wojno, Akron, OH; C. Wysham, Spokane, WA; C.K. Yuen, Winnipeg, MB; J. Zanchetta, Buenos Aires, ARG; C. Zerbini, São Paulo, BRA; T.M. Zizic, Baltimore, MD.

Conflicts of interest

Dr. Kendler is an Assistant Professor of Medicine at the University of British Columbia and has received research funding from Pfizer, Novartis, Eli Lilly, GSK, Biosante, Wyeth, Servier, Amgen, and Takeda and is a member of the Speakers Bureau and/or Advisory Boards of Novartis, Eli Lilly, Wyeth, Servier, Amgen, and Nycomed.

Dr. Ste-Marie is a member of the Advisory Board and/or received grants from the Alliance for Better Bone Health [Procter & Gamble and Sanofi-Aventis partnership], Amgen Canada, AstraZeneca, Eli Lilly, Genzyme Canada, GlaxoSmithKline, Hoffman-LaRoche Ltd., Merck Frost, Novartis Pharma, NPS Allelix, Pfizer Canada, Servier, and Zelos Therapeutics.

Ms. Taylor holds stock in Procter & Gamble, Inc.

Dr. Ringe and Dr. Vrijens both declare no disclosures.

Author information

Authors and Affiliations

  1. Osteoporosis Centre of British Columbia, 600-1285 W Broadway, Vancouver, BC, V6H 3X8, Canada

    D. L. Kendler

  2. Klinikum Leverkusen, Leverkusen, Germany

    J. D. Ringe

  3. Centre de Recherche du CHUM, Université de Montréal, Montreal, QC, Canada

    L. -G. Ste-Marie

  4. AARDEX Ltd, Zug, Switzerland

    B. Vrijens

  5. Procter & Gamble Pharmaceuticals, Inc, Mason, OH, USA

    E. B. Taylor

  6. INSERM Research Unit 831 and Université Claude Bernard Lyon, Lyon, France

    P. D. Delmas

Authors
  1. D. L. Kendler
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  2. J. D. Ringe
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  3. L. -G. Ste-Marie
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  4. B. Vrijens
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  5. E. B. Taylor
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  6. P. D. Delmas
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Corresponding author

Correspondence to D. L. Kendler.

Additional information

This study was sponsored by The Alliance for Better Bone Health (Procter & Gamble Pharmaceuticals, Inc., Mason, Ohio, and Sanofi-Aventis U.S. LLC, Bridgewater, New Jersey).

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Kendler, D.L., Ringe, J.D., Ste-Marie, L.G. et al. Risedronate dosing before breakfast compared with dosing later in the day in women with postmenopausal osteoporosis. Osteoporos Int 20, 1895–1902 (2009). https://doi.org/10.1007/s00198-009-0893-2

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