Fluoride therapy in postmenopausal osteopenic women: Effect on vertebral and femoral bone density and prediction of bone response

Pouillès, J. M.; Tremollieres, F.; Caussé, Elizabeth; Jp, Louvet; Ribot, C.

doi:10.1007/bf01880451

Cited by 25 publications

(6 citation statements)

References 21 publications

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“…However, these patients have severe deterioration of both bone quantity and micro‐architecture. One can speculate that, in younger patients, without fractures, an increase in bone mineral density may have a better benefit on bone strength 32 –34 . In this study, small doses of fluoride were used to limit side‐effects and because low doses of fluoride (37.5 mg) have been shown to be more effective than higher doses (75 mg) 35 , .…”

Section: Discussionmentioning

confidence: 98%

Osteoporosis in inflammatory bowel disease: effect of calcium and vitamin D with or without fluoride

Abitbol

Mary

Roux

et al. 2002

Aliment Pharmacol Ther

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Background: Previous data have indicated low bone formation as a mechanism of osteoporosis in inflammatory bowel disease. Fluoride can stimulate bone formation. Aim: To assess the effect of fluoride supplementation on lumbar spine bone mineral density in osteoporotic patients with inflammatory bowel disease treated in parallel with calcium and vitamin D. Methods: In this prospective, randomized, double‐blind, parallel and placebo‐controlled study, 94 patients with inflammatory bowel disease (lumbar spine T score below − 2 standard deviations, normal serum 25OH vitamin D), with a median age of 35 years, were included. Bone mineral density was measured by dual‐energy X‐ray absorptiometry. Patients were randomized to receive daily either sodium monofluorophosphate (150 mg, n=45) or placebo (n=49) for 1 year, and all received calcium (1 g) and vitamin D (800 IU). The relative change in bone mineral density from 0 to 12 months was tested in each group (fluoride or placebo) and compared between the groups. Results: Lumbar spine bone mineral density increased significantly in both groups after 1 year: 4.8 ± 5.6% (n=29) and 3.2 ± 3.8% (n=31) in the calcium–vitamin D–fluoride and calcium–vitamin D–placebo groups, respectively (P < 0.001 for each group). There was no difference between the groups (P=0.403). Similar results were observed according to corticosteroid intake or disease activity. Conclusions: Calcium and vitamin D seem to increase lumbar spine density in osteoporotic patients with inflammatory bowel disease; fluoride does not provide further benefit.

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Section: Discussionmentioning

confidence: 98%

Osteoporosis in inflammatory bowel disease: effect of calcium and vitamin D with or without fluoride

Abitbol

Mary

Roux

et al. 2002

Aliment Pharmacol Ther

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“…In our trial, a densitometric nonresponder to HRT was defined as a woman whose BMD change during the treatment was similar to the mean BMD change of the placebo group (+ 95% CI) or worse. In previous studies the definition of nonresponders to a treatment has varied [4,8]; they have been defined as women who lose bone above a certain rate or who have a negative BMD change during treatment. We considered that the definition of a densitometric nonresponder to HRT should be linked to the age-related bone loss seen especially among the early postmenopausal women deficient in estrogen.…”

Section: Discussionmentioning

confidence: 99%

Identification of Early Postmenopausal Women with No Bone Response to HRT: Results of a Five-Year Clinical Trial

Komulainen

Kröger

Tuppurainen

et al. 2000

Osteoporosis International

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Hormone replacement therapy (HRT) prevents postmenopausal bone loss and fractures. However, the occurrence of women with no bone response to HRT has not been widely examined. We identified the densitometric nonresponders to long-term HRT and investigated some characteristics and biochemical variables as possible predictors of densitometric nonresponse in postmenopausal women. The study population was a subsample of the Kuopio Osteoporosis Study (n = 14,220). A total of 464 early postmenopausal women were randomized into four treatment groups: (1) HRT (sequential combination of 2 mg estradiol valerate and 1 mg cyproterone acetate); (2) vitamin D3; (3) HRT + Vitamin D3 combined; and (4) placebo. In this study, the data from HRT and placebo groups were analyzed. Lumbar (L2-4) and femoral neck bone mineral density (BMD) were determined by dual-energy X-ray absorptiometry (DXA) at baseline and after 5 years of treatment. A densitometric nonresponder was defined as a woman whose 5-year BMD change was similar to the mean BMD change (+95% CI) of the placebo group or worse. Altogether, 74 women in the HRT group and 104 women in the placebo group complied with the treatment. According to spinal BMD analysis, 11% of the women were classified as densitometric nonresponders; the corresponding proportion for femoral BMD analysis was 26%. Both smoking (p = 0.003) and low body weight (p = 0.028) were significant risk factors for densitometric nonresponse to HRT. After 6 months of treatment the densitometric nonresponders (hip) had a significantly higher mean serum follicle stimulating hormone (FSH) level (p = 0.038) and lower increases in serum estradiol levels (p = 0.006) than the densitometric responders. The mean changes in serum FSH and alkaline phosphatase levels were significantly lower among the densitometric nonresponders (spine) than responders (p = 0.043 and 0.017, respectively). In conclusion, this prospective study shows that especially current smokers and women with low body weight are at increased risk of poor bone response to HRT. Repeated serum FSH, estradiol and alkaline phosphatase measurements during the first months of long-term HRT may be helpful in identifying the women with no bone response to HRT.

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“…The anabolic effect of fluoride on the cancellous bone mineral mass of the axial skeleton has been repeatedly recorded in human studies, although large variations in the individual therapeutic response have also often been observed [47][48][49][50][51][52][53][54]. Nevertheless, this consistent anabolic effect on bone mass has not invariably been found to be associated with an increase in bone strength.…”

Section: Predictive Value Of Preclinical Studiesmentioning

confidence: 96%

Importance of Preclinical Studies in the Development of Drugs for Treatment of Osteoporosis: A Review Related to the 1998 WHO Guidelines

Bonjour

Ammann

Rizzoli

1999

Osteoporosis International

100

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Osteoporosis, which is defined as a disease characterized by low bone mass and microarchitectural deterioration of bone tissue leading to enhanced bone fragility and a consequent increase in fracture risk, is a major health issue worldwide. Among the various strategies to prevent and cure this devastating ailment, an important objective is the development of new efficacious and safe drugs. This situation prompted the World Health Organization (WHO) to provide a comprehensive statement of guiding principles for the design, implementation and interpretation of both preclinical testing and clinical trials in osteoporosis. These guidelines, which are now available, underline the crucial importance of the preclinical evaluation, particularly for assessing the effect of an intervention on bone strength. This concept is heightened by the lack of a validated technique for noninvasively evaluating bone strength in humans and the multiple difficulties and heavy burden inherent in the evaluation of fracture rate in clinical trials. The WHO guidelines emphasize that a comprehensive and adequate preclinical program is expected to provide key information on the relationship between bone mass and strength and thus attenuate the burden of clinical studies. The present report provides a review of experimental evidence in support of the preclinical program as proposed in the WHO guidelines. This program is based on the recent development and refinement of animal models of osteoporosis that mimic the human condition according to the conceptual definition of the disease. Many preclinical studies carried out in appropriate animal models with agents that exert either antiresorbing or anabolic effects on bone indicate that they have been highly predictive of the drug action in humans in terms of both bone mass and remodeling, as well as of bone strength whenever fracture rate has been documented in clinical trials. Based on this evidence the WHO guidelines propose strategies according to which the results of preclinical evaluation will determine the end-points required in the different phases of the clinical development of the drug. Such a distribution of task assignment between preclinical and clinical programs should optimize the progress of research available to patients already suffering from or at risk of osteoporosis.

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Fluoride therapy in postmenopausal osteopenic women: Effect on vertebral and femoral bone density and prediction of bone response

Cited by 25 publications

References 21 publications

Osteoporosis in inflammatory bowel disease: effect of calcium and vitamin D with or without fluoride

Osteoporosis in inflammatory bowel disease: effect of calcium and vitamin D with or without fluoride

Identification of Early Postmenopausal Women with No Bone Response to HRT: Results of a Five-Year Clinical Trial

Importance of Preclinical Studies in the Development of Drugs for Treatment of Osteoporosis: A Review Related to the 1998 WHO Guidelines

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