Calcitonin therapy in central giant cell granuloma of the jaw: a randomized double-blind placebo-controlled study

doi:10.1016/j.ijom.2006.03.030

International Journal of Oral and Maxillofacial Surgery

Volume 35, Issue 9, September 2006, Pages 791-795

https://doi.org/10.1016/j.ijom.2006.03.030 Get rights and content

Abstract

The successful therapeutic use of calcitonin in patients with a central giant cell granuloma has been shown in several case reports. In a prospective, randomized, double-blinded, placebo-controlled clinical trial, 14 patients with a histologically confirmed central giant cell granuloma and normal calcium and parathyroid hormone serum levels were studied over 2 years. Patients were treated with intranasally administered salmon calcitonin (200 IU/day) or a placebo once a day. The placebo-controlled period was 3 months, after which all patients were treated with calcitonin for 1 year. Treatment response was assessed at the end of the placebo-controlled study phase (3 months), at the end of therapy (15 months’ timepoint with patients being on calcitonin treatment for either 12 or 15 months) and at 6 months’ follow-up. The χ²-test was used to compare the proportion of patients with a tumour reduction ≥10% of the pretreatment measurement between the 2 populations at the 3 timepoints: no differences were observed between the placebo group and the calcitonin group. At the 6-month follow-up timepoint, tumour volume had decreased by ≥10% in a total of 7 patients with a 37.9% (95% CI 31.3–44.5%) mean volume reduction in this subgroup. Complete remission was not observed.

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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Leading Clinical PaperOral Medicine/TherapeuticsCalcitonin therapy in central giant cell granuloma of the jaw: a randomized double-blind placebo-controlled study

Abstract

Section snippets

Materials and methods

Results

Aggressive versus indolent lesions

Discussion

Acknowledgments

The Calcitonin, Physiology and Pharmacology

The effects of calcium regulating hormones on bone resorption by isolated human osteoclastoma cells

J Pathol

Central giant cell lesions of the jaws; A clinicopathologic study

J Oral Maxillofac Surg

Intranasal calcitonin therapy for central giant cell granuloma

J Craniomaxillofac Surg

The multinucleate cells in the giant cell granulomas of the jaw are osteoclasts

Cancer

Central giant cell granulomas of the jaws regress with calcitonin therapy

Br J Oral Maxillofac Surg

Cellular mechanisms of osteoclast formation and lacunar resorption in giant cell granuloma of the jaw

J Oral Pathol Med

Phenotypic characterization of mononuclear and multinucleated cells of giant cell reparative granuloma of small bones

J Pathol

Antiangiogenetic therapy with interferon alpha for giant cell lesions of the jaws

J Oral Maxillofac Surg

Treatment of central giant cell granuloma of the jaw with calcitonin

Int J Oral Maxillofac Surg

Leading Clinical Paper
Oral Medicine/Therapeutics
Calcitonin therapy in central giant cell granuloma of the jaw: a randomized double-blind placebo-controlled study