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Minerva Medica 2002 December;93(6):471-8


language: Italian

Effects of the combined raloxifene-sodium fluoride therapy on bone mass and bone turnover in women with postmenopausal osteoporosis

Celi M., Letizia C., Ragno A., Minisola S., D’Erasmo E., Mazzuoli G. F.


Background. Aim of the study was to compare the effects of raloxifene (RLX) therapy alone or with a combination of RLX and slow release sodium fluoride (SRNaF) on bone mineral density (BMD) and bone turnover, at 1 year.
Methods. Ninety-two consecutive postmenopausal women with osteoporosis (49-62 yr old) were randomly allocated to a group A (n=48; RLX 60 mg/day per os) or a group B (n=44; RLX 60 mg/day per os plus SRNaF 25 mg x 2/day per os); all participants received oral calcium carbonate (500 mg x 2/day) and vitamin D3 (400 UI x 2/day) too. Lumbar spine (L1-L4) and femoral neck (FN) BMD were measured by dual energy X-ray absorptiometry (DEXA) at time 0 (T0), after 6 (T6) and 12 (T12) months; at the same time, serum bone specific alkaline phosphatase (BALP) and urinary N-terminal telopeptide of type I collagen normalized by creatinine (NTx/cr) were determined at T0, T6 and T12.
Results. Eighty-five women completed the study, 45 in group A and 40 in group B. In group B, after 1 year of treatment, we found a significant (p<0.01) increase in L1-L4 BMD (3.9±0.3%) respect to group A (2.8±0.1%); FN BMD in group B increased by 3.3±0.3% which was significantly different (p<0.01) from group A (2.3±0.1%), at 1 year. After 12 months of therapy, NTx/cr decreased significantly more (p<0.05) in group B (-36±2.6%) than group A (-29±2.0%); BALP levels increased in group B and decreased in group A: in group B BALP levels (11±1.2%) significantly increased (p<0.001) than group A (-2.1±0.1%), since 6th month.
Conclusions. These data demonstrate that the combination of antiresorptive and bone-stimulating agents may dissociate bone resorption and bone formation and thus, by synergestic effect, induce a significative increase in BMD.

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