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Long-term Effects of Neridronate in Adults with Osteogenesis Imperfecta: An Observational Three-Year Italian Study

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Abstract

The aim of this study was to assess the long-term efficacy and safety of i.v. neridronate in the treatment of osteogenesis imperfecta (OI). One hundred and fourteen patients affected by OI were included in the study. Neridronate was administered by i.v. infusion at the dosage of 2 mg/kg, up to a maximum of 100 mg at three-month intervals for 3 years. Dual X-ray absorptiometry of the lumbar spine, hip, and ultradistal and proximal radius were evaluated every 6 months. Blood calcium, phosphate, albumin, fasting urinary calcium/creatinine ratio, total serum alkaline phosphatase, and bone alkaline phosphatase were obtained at baseline and every 3 months. The mean lumbar spine and total hip BMD significantly increased from baseline to any time point (p < 0.001). The mean ultradistal radius BMD significantly increased from baseline only at month 18 (p = 0.026), 30 (p = 0.046), and 36 (p = 0.013), respectively. The mean proximal radius BMD did not change during the whole observation. The levels of bone turnover markers significantly decreased from baseline to any post-baseline observation time. The study was not able to find any statistically significant effect on fracture risk (p = 0.185). The percentage of patients with fractures was unaltered during treatment as compared to the 3-year period before treatment. The most common AEs were fragility fractures, back pain, arthralgia, fever, and joint sprain. An acute phase reaction was reported in 26 (22.8%) patients. None of the reported SAEs were considered as treatment-related. Long-term treatment with i.v. neridronate has positive effects on BMD and bone turnover markers with a good safety profile, although no significant effect on the risk of fracture was observed.

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Authors and Affiliations

  1. Rheumatology Unit, Department of Medicine, University of Verona, p.le L Scuro 2, 37100, Verona, Italy

    O. Viapiana, L. Idolazzi, A. Fassio, G. Orsolini, M. Rossini, G. Adami & D. Gatti

  2. Internal Medicine, Department of Medicine, University of Verona, p.le L Scuro 2, 37100, Verona, Italy

    F. Bertoldo

Authors
  1. O. Viapiana
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  2. L. Idolazzi
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  3. A. Fassio
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  4. G. Orsolini
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  5. M. Rossini
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  6. G. Adami
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  7. F. Bertoldo
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  8. D. Gatti
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Correspondence to L. Idolazzi.

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Conflict of interest

Ombretta Viapiana has received speaking fees from Abiogen, Amgen, Merck Sharp & Dohme Corp. Luca Idolazzi has received speaking fees from Eli Lilly, UCB, Abbvie, Novartis. Angelo Fassio, Giovanni Orsolini, and Giovanni Adami declare they have no conflict of interest. Maurizio Rossini has received speaking and consulting fees from Abiogen, Amgen, Eli-Lilly, and Merck Sharp & Dohme Corp. Davide Gatti has received speaking fees from Abiogen, Amgen, Eli-Lilly, and Neopharmed-Gentili.

Human and Animal Rights and Informed Consent

The clinical study was conducted in accordance with the ethics principles of the Declaration of Helsinki and was approved by the local ethics committee. Each enrolled patient signed the informed consent to participate in the study.

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Viapiana, O., Idolazzi, L., Fassio, A. et al. Long-term Effects of Neridronate in Adults with Osteogenesis Imperfecta: An Observational Three-Year Italian Study. Calcif Tissue Int 100, 341–347 (2017). https://doi.org/10.1007/s00223-017-0236-9

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  • DOI: https://doi.org/10.1007/s00223-017-0236-9

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