[Effects of the combined raloxifene-sodium fluoride therapy on bone mass and bone turnover in women with postmenopausal osteoporosis].
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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Cattedra di Medicina Interna, Dipartimento di Scienze Cliniche, Policlinico Umberto I, Università degli Studi di Roma La Sapienza, Rome, Italy.
Letizia
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Ragno
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Minisola
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D'Erasmo
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D000704:Analysis of Variance; D015519:Bone Density / Q000187:drug effects* / Q000502:physiology; D016723:Bone Remodeling / Q000187:drug effects / Q000502:physiology; D001862:Bone Resorption / Q000188:drug therapy / Q000503:physiopathology; D001842:Bone and Bones / Q000187:drug effects* / Q000503:physiopathology; D016022:Case-Control Studies; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy* / Q000503:physiopathology; D020849:Raloxifene Hydrochloride / Q000627:therapeutic use*; D012969:Sodium Fluoride / Q000627:therapeutic use*
D020849:Raloxifene Hydrochloride; D012969:Sodium Fluoride