Treatment of postmenopausal vertebral osteopenia with monofluorophospate: A long-term calcium-controlled study

Gambacciani, Marco; Spinetti, A.; Taponeco, Fabio; Piaggesi, Laura; Cappagli, Barbara; Ciaponi, Massimo; Rovati, Lucio C.; Genazzani, Andrea Riccardo

doi:10.1007/bf01626610

Cited by 20 publications

(9 citation statements)

References 15 publications

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“…The women in these trials were all de®ned as osteoporotic, according to the de®nition of osteoporosis at the time of the trials (presence of vertebral fractures in earlier trials and low BMD in more recent trials). Seven trials used sodium¯uoride [11,18,21,22,24± 28], three used mono¯uorophosphate [23,29,30] and one used both types of¯uoride [22]. Two used high dosages of¯uoride [11,26].…”

Section: Description Of the Included Studiesmentioning

confidence: 99%

Fluoride for the Treatment of Postmenopausal Osteoporotic Fractures: A Meta-Analysis

Haguenauer

Welch

Shea

et al. 2000

Osteoporosis International

126

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We conducted an effectiveness meta-analysis to determine the efficacy of fluoride therapy on bone loss, vertebral and nonvertebral fractures and side effects in postmenopausal women. A literature search was conducted on MEDLINE, Current Contents and the Cochrane Controlled Trial Registry. Two independent reviewers selected randomized controlled trials which met predetermined inclusion criteria. They independently extracted data using predetermined forms and assessed the methodologic quality of the trials using a validated scale. For dichotomous outcomes, the relative risk (RR) was calculated, and for continuous outcomes, the weighted mean difference (WMD) of percentage change from baseline was calculated. Where heterogeneity existed (determined by a chi-square test) a random effects model was used. Eleven studies (1429 subjects) met the inclusion criteria. The increase in lumbar spine bone mineral density (BMD) was found to be higher in the treatment group than in the control group with a WMD 8.1% (95% CI: 7.15, 9.09) after 2 years of treatment and 16.1% (95% CI: 14.65, 17.5) after 4 years. The RR for new vertebral fractures was not significant at 2 years [0.87 (95% CI: 0.51, 1.46)] or at 4 years [0.9 (95% CI: 0.71, 1.14)]. The RR for new nonvertebral fractures was not significant at 2 years [1.2 (95% CI: 0.68, 2.10)] but was increased at 4 years in the treated group [1.85 (95% CI: 1.36, 2.50)], especially if used at high doses and in a non-slow-release form. The RR for gastrointestinal side effects was not significant at 2 years [2.18 (95% CI: 0.86, 1.21)] but was increased at 4 years in the treated group [2.18 (95% CI: 1.69, 4.57)], especially if fluoride was used at high doses and in a non-slow-release form. The number of withdrawals and dropouts was not different between treated and control groups at 2 and 4 years. Thus, although fluoride has an ability to increase bone mineral density at the lumbar spine, it does not result in a reduction in vertebral fractures. Increasing the dose of fluoride increases the risk of nonvertebral fractures and gastrointestinal side effects without any effect on the vertebral fracture rate.

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Section: Description Of the Included Studiesmentioning

confidence: 99%

Fluoride for the Treatment of Postmenopausal Osteoporotic Fractures: A Meta-Analysis

Haguenauer

Welch

Shea

et al. 2000

Osteoporosis International

126

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“…The total body bone mineral (TBBM; milligrams per cm 2 ) was measured in the supine position by dual energy x-ray absorptiometry (DEXA) using a Lunar DPX (Lunar Corp., Madison, WI), as previously reported (13,14). Lean and adipose tissue weight and abdominal fat weight were determined from the DEXA total body scans (15)(16)(17)(18).…”

Section: Methodsmentioning

confidence: 99%

Body Weight, Body Fat Distribution, and Hormonal Replacement Therapy in Early Postmenopausal Women

Gambacciani

Ciaponi

Cappagli

et al. 1997

The Journal of Clinical Endocrinology & Metabolism

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250

108

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Body weight was measured, and body fat distribution was determined by dual energy x-ray in early postmenopausal women given either oral calcium (500 mg/day; control group; n ϭ 12) or hormonal replacement therapy (HRT), a combination of estradiol valerate (2 mg/day for 21 days) with cyproterone acetate (1 mg/day in the last 10 days of the treatment cycle; n ϭ 15). There were no differences in basal body weight or body fat distribution in the two groups before the study. In the control group, a significant (P Ͻ 0.05) increase in body weight (from 61.8 Ϯ 2.1 to 63.3 Ϯ 1.9 kg after 12 months) paralleled a slight, but significant (P Ͻ 0.05), increase in total body fat mass (from 23.8 Ϯ 2.2 to 24.7 Ϯ 2.2 kg), with an increase in fat in the trunk (from 10.2 Ϯ 0.4 to 11.3 Ϯ 0.4 kg; P Ͻ 0.01) and arms (from 2.4 Ϯ 0.5 to 2.7 Ϯ 0.2 kg; P Ͻ 0.05). These findings demonstrate a shift to a prevalent central android fat distribution after 12 months of observation in untreated postmenopausal women. Conversely, in the HRT group, total body bone mineral showed a significant (from 1089 Ϯ 28 to 1106 Ϯ 29 mg/cm 2 ; P Ͻ 0.05) increase after 12 months, with no significant increase in body weight (from 62.2 Ϯ 1.6 to 62.7 Ϯ 1.6 kg), and no modifications in trunk (from 10.0 Ϯ 0.2 to 9.8 Ϯ 0.3 kg) and arm (from 2.43 Ϯ 0.2 to 2.5 Ϯ 0.1 kg) fat, but a significant increase in leg fat (from 7.1 Ϯ 0.3 to 8.3 Ϯ 0.4 kg; P Ͻ 0.05). The present results suggest that HRT can counteract at least in part the postmenopausal increase in body weight and body fat and prevent central body fat distribution after menopause. (J Clin Endocrinol Metab 82: 414 -417, 1997)

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“…No differences in the occurrence of adverse skeletal effects (vertebral and non-vertebral fractures and lower-limb pain presumably caused by microfractures) were found in those studies where the fluoride dosis was 4.5 to 26 mg/day (up to 0.4 mg/kg/day) (Hansson and Roos, 1987;Christiansen et al, 1980;Grove and Halver, 1981;Gambacciani et al, 1995;Sebert et al, 1995). In two studies Pak et al, 1995) there was on the contrary a significantly reduced occurrence of vertebral fractures in the fluoride group compared to the placebo group.…”

Section: Skeletal Effectsmentioning

confidence: 88%

“…No gastrointestinal effects or the same frequency of nausea and dyspepsia as in the placebo group were observed in postmenopausal women administered 4.5-22 mg fluoride/day (assumed to correspond to 0.13-0.37 mg fluoride/kg body weight/day) over 12 weeks and up to 3 years (Hansson and Roos, 1987;Christiansen et al, 1980;Grove and Halver, 1981;Reginster et al, 1998;Gambacciani et al, 1995;Meunier et al, 1998;Pak et al, 1995;Sebert et al, 1995).…”

Section: Gastrointestinal Effectsmentioning

confidence: 91%

Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies (NDA) on a request from the Commission related to the Tolerable Upper Intake Level of Fluoride

Products¹

2005

EFSA Journal

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SUMMARYFluoride is not essential for human growth and development but is beneficial in the prevention of dental caries (tooth decay) when ingested in amounts of about 0.05 mg/kg body weight per day and when applied topically with dental products such as toothpaste. Dental enamel which contains fluoride is less likely to develop caries, because of greater resistance to ingested acids or to acids generated from ingested sugars by the oral bacteria. In addition, fluoride inhibits sugar metabolism by oral bacteria.Fluoride content of the body is not under physiological control. Absorbed fluoride is partly retained in bone and partly excreted, predominantly via the kidney. In infants retention in bone can be as high as 90% of the absorbed amount, whereas in adults retention is 50% or less. Fluoride is also incorporated into dental enamel during tooth formation.Excessive intake of fluoride during enamel maturation before tooth eruption from birth to eight years of age, when enamel formation is complete, can lead to reduced mineral content of enamel and to dental fluorosis of deciduous but predominantly of permanent teeth. The incidence and severity of dental fluorosis is dose-dependent. Mild dental fluorosis is not readily apparent and is associated with increased resistance to caries. The Panel considered moderate dental fluorosis, which is characterised by staining and minute pitting of teeth, to be an adverse effect. On the basis that the prevalence of moderate dental fluorosis of permanent teeth is less than 5% in populations ingesting 0.08-0.12 mg fluoride/kg body weight/day, the Panel considered that the upper level (UL) for fluoride is 0.1 mg fluoride/kg/day in children aged 1-8 years. This is equivalent to 1.5 and 2.5 mg fluoride per day in children aged 1-3 years and 4-8 years, respectively.Fluoride accretion in bone increases bone density but excessive long term intake reduces bone strength and increases risk of fracture and skeletal fluorosis (stiffness of joints, skeletal deformities). Studies with therapeutic oral administration of fluoride in amounts of 0.6 mg/kg body weight/day in postmenopausal women over several years increased the risk for nonvertebral bone fractures significantly. The Panel applied an uncertainty factor of 5 to derive an UL of 0.12 mg/kg body weight/day. This is equivalent to an UL of 5 mg/day in children aged 9-14 years and 7 mg/day for age 15 years and older, including pregnant and lactating women.The UL for fluoride applies to intake from water, beverages, foodstuffs, including fluoridated salt, dental health products and fluoride tablets for caries prevention.Children aged 1-8 years have fluoride intakes from food and water well below the UL provided the fluoride content of their drinking water is not higher than 1.0 mg/L. An increase

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Treatment of postmenopausal vertebral osteopenia with monofluorophospate: A long-term calcium-controlled study

Cited by 20 publications

References 15 publications

Fluoride for the Treatment of Postmenopausal Osteoporotic Fractures: A Meta-Analysis

Fluoride for the Treatment of Postmenopausal Osteoporotic Fractures: A Meta-Analysis

Body Weight, Body Fat Distribution, and Hormonal Replacement Therapy in Early Postmenopausal Women

Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies (NDA) on a request from the Commission related to the Tolerable Upper Intake Level of Fluoride

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