Calcified Tissue International

, Volume 83, Issue 5, pp 301–307

Intramuscular Neridronate in Postmenopausal Women with Low Bone Mineral Density

  • Silvano Adami
  • Davide Gatti
  • Francesco Bertoldo
  • Leonardo Sartori
  • Ombretta Di Munno
  • Paolo Filipponi
  • Claudio Marcocci
  • Bruno Frediani
  • Ernesto Palummeri
  • Carmelo Erio Fiore
  • Daniele Costi
  • Maurizio Rossini
Article

DOI: 10.1007/s00223-008-9179-5

Cite this article as:
Adami, S., Gatti, D., Bertoldo, F. et al. Calcif Tissue Int (2008) 83: 301. doi:10.1007/s00223-008-9179-5

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 (< 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.

Keywords

Postmenopausal osteoporosis Neridronate Bisphosphonate Bone mineral density Bone turnover marker 

Copyright information

© Springer Science+Business Media, LLC 2008

Authors and Affiliations

  • Silvano Adami
    • 1
  • Davide Gatti
    • 1
  • Francesco Bertoldo
    • 2
  • Leonardo Sartori
    • 3
  • Ombretta Di Munno
    • 4
  • Paolo Filipponi
    • 5
  • Claudio Marcocci
    • 6
  • Bruno Frediani
    • 7
  • Ernesto Palummeri
    • 8
  • Carmelo Erio Fiore
    • 9
  • Daniele Costi
    • 10
  • Maurizio Rossini
    • 1
  1. 1.Rheumatology Unit, Ospedale di ValeggioUniversity of VeronaValeggio, VeronaItaly
  2. 2.Medicina DUniversity of VeronaVeronaItaly
  3. 3.Clinica Medica IUniversity of PaduaPaduaItaly
  4. 4.Department of Internal Medicine, Rheumatology UnitUniversity of PisaPisaItaly
  5. 5.Medicina GeneraleOspedale di UmbertideUmbertideItaly
  6. 6.Dipartimento di Endocrinologia e MetabolismoUniversity of PisaPisaItaly
  7. 7.Department of RheumatologyUniversity of SienaSienaItaly
  8. 8.Dipartimento di GerontologiaOspedale GallieraGenoaItaly
  9. 9.Clinica Medica L. CondorelliUniversity of CataniaCataniaItaly
  10. 10.Clinica MedicaUniversity of ParmaParmaItaly

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