IS ADDITION OF SODIUM-FLUORIDE TO CYCLICAL ETIDRONATE BENEFICIAL IN THE TREATMENT OF CORTICOSTEROID-INDUCED OSTEOPOROSIS

Objective-To investigate whether administration of sodium fluoride (Na F) in addition to cyclical etidronate has a positive effect on bone mi neral density (BMD) in patients with established osteoporosis during c ontinued treatment with corticosteroids. Patients and methods-47 patie nts who were receiving treatment with corticosteroids were included in a two year randomised, double blind, placebo controlled trial. Establ ished osteoporosis was defined as a history of a peripheral fracture o r a vertebral deformity, or both, on a radiograph. All patients were t reated with cyclical etidronate, calcium, and either NaF (25 twice dai ly) or placebo. Vitamin D was supplemented in the case of a low serum 25 (OH) vitamin D concentration. BMD of the lumbar spine and hips was measured at baseline and at 6, 12, 18, and 24 months. Results-After tw o years of treatment, the BMD of the lumbar spine in the etidronate/Na F group had increased by +9.3% (95% confidence intervals (CI): +2.3% t o +16.2%, p<0.01), while the BMD in the etidronate/placebo group was u nchanged: +0.3% (95% CI: -2.2% to +2.8%). The difference in the change in BMD between groups was +8.9% (95% CI: +1.9% to +16.0%, p<0.01). Fo r the hips, no significant changes in BMD were observed in the etidron ate/NaF group after two years: -2.5% (95% CI: -6.8% to +1.8%; in the e tidronate/placebo group BMD had significantly decreased: -4.0% (95% CI : -6.6% to -1.4%; p<0.01). The difference between the groups was not s ignificant: +1.5% (95% CI: -3.4% to +6.4%). No significant differences in number of vertebral deformities and peripheral fractures were obse rved between the two groups. Conclusion-The effect of combination trea tment with NaF and etidronate on the BMD of the lumbar spine in cortic osteroid treated patients with established osteoporosis is superior to that of etidronate alone.