Calcified Tissue International

, Volume 83, Issue 5, pp 301-307

First online:

Intramuscular Neridronate in Postmenopausal Women with Low Bone Mineral Density

  • Silvano AdamiAffiliated withRheumatology Unit, Ospedale di Valeggio, University of Verona Email author 
  • , Davide GattiAffiliated withRheumatology Unit, Ospedale di Valeggio, University of Verona
  • , Francesco BertoldoAffiliated withMedicina D, University of Verona
  • , Leonardo SartoriAffiliated withClinica Medica I, University of Padua
  • , Ombretta Di MunnoAffiliated withDepartment of Internal Medicine, Rheumatology Unit, University of Pisa
  • , Paolo FilipponiAffiliated withMedicina Generale, Ospedale di Umbertide
  • , Claudio MarcocciAffiliated withDipartimento di Endocrinologia e Metabolismo, University of Pisa
  • , Bruno FredianiAffiliated withDepartment of Rheumatology, University of Siena
  • , Ernesto PalummeriAffiliated withDipartimento di Gerontologia, Ospedale Galliera
    • , Carmelo Erio FioreAffiliated withClinica Medica L. Condorelli, University of Catania
    • , Daniele CostiAffiliated withClinica Medica, University of Parma
    • , Maurizio RossiniAffiliated withRheumatology Unit, Ospedale di Valeggio, University of Verona

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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.


Postmenopausal osteoporosis Neridronate Bisphosphonate Bone mineral density Bone turnover marker