| Abstract | 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 METHODS: 47 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. RESULTS: After 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. CONCLUSION: The 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. |
| Authors | W F Lems, J W Jacobs, J W Bijlsma, G J van Veen, H H Houben, H C Haanen, M I Gerrits, H J van Rijn
(Affiliation: Department of Rheumatology and Clinical Immunology, University Hospital Utrecht, The Netherlands.)
|
| Journal | Annals of the rheumatic diseases
(Ann Rheum Dis)
Vol. 56
Issue 6
Pg. 357-63
(Jun 1997)
ISSN: 0003-4967 ENGLAND |
| PMID | 9227164
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
| Chemical References |
- Glucocorticoids
- Etidronic Acid
- Sodium Fluoride
|
| Topics |
- Adult
- Aged
- Bone Density
(drug effects)
- Double-Blind Method
- Drug Administration Schedule
- Drug Therapy, Combination
- Etidronic Acid
(therapeutic use)
- Female
- Glucocorticoids
(adverse effects)
- Humans
- Lumbar Vertebrae
(physiopathology)
- Male
- Middle Aged
- Osteoporosis
(chemically induced, drug therapy, physiopathology)
- Sodium Fluoride
(therapeutic use)
|
