Extended reports
Is addition of sodium fluoride to cyclical etidronate beneficial
in the treatment of corticosteroid induced osteoporosis?
a Department of
Rheumatology and Clinical Immunology, University Hospital Utrecht, the
Netherlands , b Department of Rheumatology, de Wever Hospital,
Heerlen, the Netherlands , c Department of Rheumatology, St Antonius Hospital,
Nieuwegein, the Netherlands , d Department of Clinical Chemistry, University Hospital
Utrecht, the Netherlands
Correspondence to: Dr W F Lems, Department of Rheumatology and Clinical Immunology, University Hospital Utrecht, P O Box 85500, 3508 CA Utrecht, the Netherlands.
Accepted for publication 3 March 1997
OBJECTIVE
To investigate whether administration of
sodium fluoride (NaF) in addition to cyclical etidronate
has a positive effect on bone mineral density (BMD) in
patients with established osteoporosis during continued treatment with corticosteroids.
PATIENTS AND METHODS47 patients who were receiving
treatment with corticosteroids were included in a two year randomised,
double blind, placebo controlled trial. Established osteoporosis was
defined as a history of a peripheral fracture or a vertebral deformity,
or both, on a radiograph. All patients were treated with cyclical
etidronate, calcium, and either NaF (25 twice daily) 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.
RESULTSAfter two years of treatment, the BMD of
the lumbar spine in the etidronate/NaF group had increased by +9.3%
(95% confidence intervals (CI): +2.3% to +16.2%, p<0.01), while the
BMD in the etidronate/placebo group was unchanged: +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). For the hips, no
significant changes in BMD were observed in the etidronate/NaF group
after two years: 2.5% (95% CI: 6.8% to +1.8%); in the
etidronate/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 significant: +1.5% (95% CI: 3.4% to +6.4%). No
significant differences in number of vertebral deformities and
peripheral fractures were observed between the two groups.
CONCLUSIONThe effect of combination treatment
with NaF and etidronate on the BMD of the lumbar spine in
corticosteroid treated patients with established osteoporosis is
superior to that of etidronate alone.
© 1997 by Annals of the Rheumatic Diseases
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