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Intramuscular Neridronate in Postmenopausal Women with Low Bone Mineral Density

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Abstract

Compliance to osteoporosis treatment with oral bisphosphonates is very poor. Intermittent intravenous bisphosphonate is a useful alternative, but this route is not readily available. Neridronate, a nitrogen-containing bisphosphonate that can be given intramuscularly (IM), was tested in a phase 2 clinical trial in 188 postmenopausal osteoporotic women randomized to IM treatment with 25 mg neridronate every 2 weeks, neridronate 12.5 or 25 mg every 4 weeks, or placebo. All patients received calcium and vitamin D supplements. The patients were treated over 12 months with 2-year posttreatment follow-up. After 12-month treatment, all three doses were associated with significant bone mineral density (BMD) increases at both the total hip and spine. A significant dose–response relationship over the three doses was observed for the BMD changes at the total hip but not at the spine. Bone alkaline phosphatase decreased significantly by 40–55% in neridronate-treated patients, with an insignificant dose–response relationship. Serum type I collagen C-telopeptide decreased by 58–79%, with a significant dose–response relationship (P < 0.05). Two years after treatment discontinuation, BMD declined by 1–2% in each dose group, with values still significantly higher than baseline at both the spine and the total hip. Bone turnover markers progressively increased after treatment discontinuation, and on the second year of follow-up the values were significantly higher than pretreatment baseline. The results of this study indicate that IM neridronate might be of value for patients intolerant to oral bisphosphonates and unwilling or unable to undergo intravenous infusion of bisphosphonates.

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Acknowledgment

The study was designed by one of the authors (S. A.) and fully supported by an unlimited grant from Abiogen Pharma (Pisa, Italy).

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Authors and Affiliations

  1. Rheumatology Unit, Ospedale di Valeggio, University of Verona, 37067, Valeggio, Verona, Italy

    Silvano Adami, Davide Gatti & Maurizio Rossini

  2. Medicina D, University of Verona, Verona, Italy

    Francesco Bertoldo

  3. Clinica Medica I, University of Padua, Padua, Italy

    Leonardo Sartori

  4. Department of Internal Medicine, Rheumatology Unit, University of Pisa, Pisa, Italy

    Ombretta Di Munno

  5. Medicina Generale, Ospedale di Umbertide, Umbertide, Italy

    Paolo Filipponi

  6. Dipartimento di Endocrinologia e Metabolismo, University of Pisa, Pisa, Italy

    Claudio Marcocci

  7. Department of Rheumatology, University of Siena, Siena, Italy

    Bruno Frediani

  8. Dipartimento di Gerontologia, Ospedale Galliera, Genoa, Italy

    Ernesto Palummeri

  9. Clinica Medica L. Condorelli, University of Catania, Catania, Italy

    Carmelo Erio Fiore

  10. Clinica Medica, University of Parma, Parma, Italy

    Daniele Costi

Authors
  1. Silvano Adami
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  2. Davide Gatti
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  3. Francesco Bertoldo
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  4. Leonardo Sartori
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  5. Ombretta Di Munno
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  6. Paolo Filipponi
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  7. Claudio Marcocci
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  8. Bruno Frediani
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  9. Ernesto Palummeri
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  10. Carmelo Erio Fiore
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  11. Daniele Costi
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  12. Maurizio Rossini
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Corresponding author

Correspondence to Silvano Adami.

Appendix: Centers That Participated in the Study

Appendix: Centers That Participated in the Study

Riabilitazione Reumatologica, Università di Verona (S. Adami, M. Rossini); U.O. Medicina D, Università di Verona (V. Lo Cascio, F. Bertoldo); Clinica Medica I, Università di Padova (G. Realdi, L. Sartori); U.O. Reumatologia, Università Di Pisa (O. Di Munno, A. Delle Sedie); Ospedale di Umbertide (P. Filippini, S. Cristallini); Dipartimento Endocrinologia e Metabolismo, Università di Pisa (C. Marcocci, E. Vignali); Policlinico Le Scotte, Università di Siena (R. Marcolongo, B. Frediani); Ospedale Galliera, Genova (E. Palummeri, A. Barone); Clinica Medica I, Università di Catania (C.E. Fiore, P. Pennisi); Clinica Medica, Università di Parma (D. Costi).

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Adami, S., Gatti, D., Bertoldo, F. et al. Intramuscular Neridronate in Postmenopausal Women with Low Bone Mineral Density. Calcif Tissue Int 83, 301–307 (2008). https://doi.org/10.1007/s00223-008-9179-5

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  • DOI: https://doi.org/10.1007/s00223-008-9179-5

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