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Rapid Onset and Sustained Efficacy (ROSE) study: results of a randomised, multicentre trial comparing the effect of zoledronic acid or alendronate on bone metabolism in postmenopausal women with low bone mass

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Abstract

Introduction

The open-label Rapid Onset and Sustained Efficacy (ROSE) study was designed to compare a once-yearly intravenous (iv) dose of zoledronic acid with a once-weekly oral dose of alendronate with respect to markers of bone turnover in approximately 600 postmenopausal women in Germany.

Methods

Levels of N-telopeptide of collagen type I (NTx) and procollagen 1 C terminal extension peptide (P1NP) were assessed during the study. The primary objective was to assess if zoledronic acid was superior to alendronate in reducing serum NTx levels after 12 months’ treatment.

Results

A significantly greater reduction in NTx levels from baseline to month 12 (as determined by the area under the curve) was observed in patients treated with zoledronic acid (n = 408) versus those receiving alendronate (n = 196; 0.282 ng/mL vs. 0.270 ng/mL; P = 0.012). The reduction in levels of P1NP after 1 year was also significantly greater in patients treated with zoledronic acid compared with those receiving alendronate (28.21 vs. 25.53 ng/mL; P = 0.0024). The overall incidence of adverse events was similar between groups; both treatments were generally well tolerated. Although post-dose symptoms, including the incidence of influenza-like symptoms, were higher with zoledronic acid than alendronate initially, the incidence was similar between groups from days 4–360. Gastrointestinal symptoms were more frequent with alendronate than zoledronic acid throughout the study.

Conclusion

In this study, once-yearly iv zoledronic acid provided a greater and faster reduction in the levels of NTx and P1NP versus once-weekly oral alendronate.

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Acknowledgments

The authors are thankful to all the administrators of each of the 95 sites that participated in this study for their contribution and support.

The study was funded by Novartis Pharma GmbH, Nuremberg, Germany.

Medical writing support was provided by Caroline Masterman at ACUMED® (Tytherington, UK), with funding from Novartis Pharma GmbH, Nuremberg, Germany.

Conflicts of interest

Dr. P Hadji has received honoraria, unrestricted educational grants, and research funding from the following companies: Amgen, AstraZeneca, Eli Lilly, GlaxoSmithKline, Novartis, Pfizer, Roche, and Wyeth. Dr. PH Kann, Dr. V Ziller, Dr. W Spieler, Mr. Gamerdinger, and Dr. Moricke have no conflicts of interest. Dr. H Loeffler and Dr. K Articus are employees of Novartis Pharma GmbH.

Funding sources

The study was funded by Novartis Pharma GmbH, Nuremberg, Germany

Author information

Authors and Affiliations

  1. Philipps-University of Marburg, Marburg, Germany

    P. Hadji, P. H. Kann & V. Ziller

  2. Orthopedic Practice, Bautzen, Germany

    D. Gamerdinger

  3. Research Center for Osteology and Rheumatology, Zerbst, Germany

    W. Spieler

  4. Novartis Pharma GmbH, Nuremberg, Germany

    H. Loeffler & K. Articus

  5. Endocrinologic Practice, Magdeburg, Germany

    R. Möricke

  6. Head of the Department of Gynaecological Endocrinology, Reproductive Medicine and Osteoporosis, Philipps-University of Marburg, Baldingerstrasse, 35033, Marburg, Germany

    P. Hadji

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  1. P. Hadji
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Correspondence to P. Hadji.

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Hadji, P., Gamerdinger, D., Spieler, W. et al. Rapid Onset and Sustained Efficacy (ROSE) study: results of a randomised, multicentre trial comparing the effect of zoledronic acid or alendronate on bone metabolism in postmenopausal women with low bone mass. Osteoporos Int 23, 625–633 (2012). https://doi.org/10.1007/s00198-011-1583-4

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  • DOI: https://doi.org/10.1007/s00198-011-1583-4

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