Comparison of intravenous and intramuscular neridronate regimens for the treatment of Paget disease of bone.

Abstract

Aminobisphosphonates actually represent the most common treatment for Paget disease of bone (PDB). In a previous study we demonstrated that either zoledronic acid (4 mg) or neridronate (200 mg) given as a single intravenous infusion showed a similar short-term efficacy in achieving biochemical remission in up to 90% of patient nonresponders to pamidronate. In this study we compared the long-term (36 months) effects of a same neridronate dose (200 mg) given as an intravenous (100-mg infusion for 2 consecutive days) or intramuscular (25-mg injection weekly for 2 months) regimen in 56 patients with active PDB. All patients were advised to receive calcium plus vitamin D supplementation throughout the study period. At 6 months, 92.6% and 96.5% of patients receiving intravenous and intramuscular neridronate, respectively, achieved a therapeutic response [defined as normalization of alkaline phosphatase (ALP) levels or a reduction of at least 75% in total ALP excess]. The response to treatment was significantly correlated with baseline ALP and 25-hydroxyvitamin D [25(OH)D] levels at 6 months. The decrease in ALP levels was highest in patients with higher baseline total or bone-specific ALP levels and with higher 25(OH)D levels at 6 months. Response rates were maintained at 12 months but decreased progressively at 24 and 36 months without significant differences between the two neridronate regimens. Both regimens were well tolerated. The only relevant side effect was an acute-phase response occurring in 14% of the patients. In conclusion, these results indicate that a 200-mg intramuscular neridronate course has a similar efficacy as an intravenous infusion of the same dose for the treatment of PDB and might be of particular value for patients intolerant to oral bisphosphonates and unwilling or unable to undergo intravenous infusions.

• Authors: Daniela Merlotti, Domenico Rendina, Luigi Gennari, Giuseppe Mossetti, Fernando Gianfrancesco, Giuseppe Martini, Gianpaolo De Filippo, Annalisa Avanzati, Beatrice Franci, Maria Stella Campagna, Pasquale Strazzullo, Ranuccio Nuti
• Journal: Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research (J Bone Miner Res) Vol. 26 Issue 3 Pg. 512-8 (Mar 2011) ISSN: 1523-4681 [Electronic] United States
• PMID: 20814970 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2011 American Society for Bone and Mineral Research.

Chemical References

• Bone Density Conservation Agents
• Diphosphonates
• Vitamin D
• 6-amino-1-hydroxyhexane-1,1-diphosphonate
• 25-hydroxyvitamin D
• Alkaline Phosphatase

Topics

• Aged
• Alkaline Phosphatase (blood)
• Bone Density Conservation Agents (administration & dosage, adverse effects, therapeutic use)
• Diphosphonates (administration & dosage, adverse effects, therapeutic use)
• Female
• Humans
• Infusions, Intravenous
• Injections, Intramuscular
• Male
• Osteitis Deformans (blood, drug therapy, enzymology)
• Pain (drug therapy)
• Quality of Life
• Time Factors
• Treatment Outcome
• Vitamin D (analogs & derivatives, blood)