International Journal of Oral and Maxillofacial Surgery
Leading Clinical Paper
Oral Medicine/TherapeuticsCalcitonin therapy in central giant cell granuloma of the jaw: a randomized double-blind placebo-controlled study
Oral Medicine/Therapeutics
Section snippets
Materials and methods
Results from an earlier pilot study of 4 patients treated with synthetic human calcitonin10 were used to design a randomized, double-blind, placebo-controlled study of calcitonin therapy in patients with a CGCG. In this study, the null hypothesis was tested that there would be no difference in the proportion of patients with tumour reduction between the 2 treatment groups at 3 months. With a sample size of 7 patients per group, the study would have power of 86.9% to yield a statistically
Results
Over a period of 2 years 14 patients with a CGCG were included. The mean age was 26 years (22 years in the calcitonin group versus 29 years in the placebo group) and the male:female ratio was 6:8 (5:2 in the calcitonin group and 1:6 in the placebo group) (Table 1). Four patients presented with aggressive lesions (3 in the calcitonin group, 1 in the placebo group). Three patients had recurrence after earlier surgical treatment.
After 4 months of treatment 1 patient (no. 9, calcitonin group) was
Aggressive versus indolent lesions
Changes in tumour size over time were variable in the 4 patients with aggressive lesions, whereas reduction or stabilization of tumour size was consistent for indolent lesions at the end of therapy in both groups (i.e. patients receiving calcitonin for either 12 months or 15 months) (Table 5). Interestingly, continuing regression (≥10%) after cessation of therapy was observed in 5 patients (nos 2, 3, 4, 6, 7; see Table 3). The difference in the proportion of patients with tumour volume
Discussion
The therapeutic concept for administration of calcitonin in the treatment of CGCCs is based on an immunohistochemical study, using osteoclast-specific monoclonal antibodies, that demonstrated that giant cells in CGCGs are osteoclasts5. This was suspected from the in vitro reaction of giant cells to calcitonin and the behaviour of giant cells in cortical bone, causing bone excavation similarly to osteoclasts2, 5. The multinucleated giant cells further exhibit all the cytochemical and functional
Acknowledgments
This study was supported by a grant from the Dutch Association of Oral and Maxillofacial Surgeons.
The medication for this study was provided by Novartis Pharma AG, Basel, Switzerland.
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