Is addition of sodium fluoride to cyclical etidronate beneficial in the treatment of corticosteroid induced osteoporosis?

Abstract

Objective-To investigate whether administration of sodium fluoride (NaF) in addition to cyclical etidronate has a positive eVect 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 diVerence 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 diVerence between the groups was not significant: +1.5% (95% CI: −3.4% to +6.4%). No significant diVerences in number of vertebral deformities and peripheral fractures were observed between the two groups. Conclusion-The eVect 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.

Treatment of established osteoporosis: a systematic review and cost-utility analysis

“…58,72,104,110,115,190,[192][193][194][195] In six studies which included vertebral fracture as an outcome measure, there was no apparent differentiation between primary and secondary outcome measures. 74,76,79,163,164,191 Non-vertebral fracture was a primary outcome measure in one study 193 and a secondary outcome measure in a further eight.…”

“…74,76,79,163,164,191 Non-vertebral fracture was a primary outcome measure in one study 193 and a secondary outcome measure in a further eight. 70,75,109,110,115,124,176,192 It was mentioned in two further studies that did not appear to differentiate between primary and secondary outcome measures. 74,191 In one study, data were collected on symptomatic fractures only as part of adverse event reporting; vertebral and non-vertebral fractures were not reported separately.…”

“…93 In 13 studies, vertebral fracture incidence was reported as the number of patients in each arm sustaining such fractures. 58,70,72,75,109,124,163,166,[190][191][192][193]195 In nine studies, non-vertebral fracture incidence was reported as the number of patients in each arm sustaining fractures. 79,93,109,110,115,124,176,192,193 In one study, 70 which was published only in abstract form, the results were presented without unmasking the two groups.…”

Glucocorticoid-Induced Osteoporosis: From Basic Mechanisms to Clinical Aspects

“…However, no reduction in the incidence of fractures was observed. Moreover, fl uoride induced bone loss at the femoral neck [223,224] . Since most of the evidence indicates that sodium fl uoride does not provide architecturally competent bone, its use is currently not recommended for GCOP [175] .…”

Preventing Steroid-Induced Osteoporosis

“…On comparison after two years in the fluoride group and placebo treated group the BMD of femoral neck had increased by 2.2% and decreased by 3.8% respectively. [17] Fluoride increases BMD at the lumbar spine but has no effect at the hip. Another anabolic agent is para thyroid hormone (PTH), which has been used in SIOP.…”