Treatment of postmenopausal osteoporosis with slow-release sodium fluoride: final report of a randomized controlled trial

Pak, Charles Y.C.; Sakhaee, Khashayar; Adams‐Huet, Beverley; Piziak, Veronica; Peterson, Roy D.; Poindexter, John R.

doi:10.1016/0378-5122(96)83754-6

Cited by 18 publications

(31 citation statements)

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“…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: 99%

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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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Section: Gastrointestinal Effectsmentioning

confidence: 99%

“…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. Meunier et al (1998) reported a significantly higher incidence of lower-limb pain in the group receiving fluoride 20-26 mg/day compared to the placebo group.…”

Section: Skeletal Effectsmentioning

confidence: 99%

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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2005

EFSA Journal

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“…The most potent bone anabolic agents that currently are available are sodium fluoride and recombinant human PTH. Sodium fluoride is highly effective in augmenting bone formation, increasing bone density, and in some studies reducing fracture rates (94,95). These studies were conducted in patients with uncomplicated osteoporosis.…”

Section: Preventive Strategiesmentioning

confidence: 99%

Pathogenesis and Prevention of Bone Loss in Patients Who Have Kidney Disease and Receive Long-Term Immunosuppression

Cunningham¹

2007

Journal of the American Society of Nephrology

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The coexistence of kidney disease with a need for immunosuppressive therapy leads to the convergence of several threats to bone. These comprise general effects of the primary disease, e.g., inflammatory state, more specific effects of acute renal failure or chronic kidney disease, and effects of therapies. Multisystem inflammatory disease that requires immunosuppression is associated frequently with kidney damage, and any reduction of kidney function that takes the patient into or beyond chronic kidney disease stage 2 for more than a short time is likely to have a negative impact on bone health. Bone mineral density frequently is low and fracture rates are high, although correlations often are poor. Chronic inflammation leads to local and systemic imbalance between bone formation and resorption. Upregulation of NF-␤ ligand (RANKL) and variable downregulation of osteoprotegerin are implicated, and bone health may improve in response to treatment of the inflammatory state. Certain immunosuppressive agents, especially glucocorticoids and calcineurin inhibitors, contribute further to bone loss. Antiresorptive agents such as bisphosphonates are used widely and, although able to prevent loss of bone mineral density, have uncertain effects on fracture rates. Augmentation of anabolic activity is desirable but elusive. Synthetic parathyroid hormone is untested but has potential. Manipulation of the RANKL/osteoprotegerin system now is feasible using antibodies to RANKL or synthetic osteoprotegerin. In the future, manipulation of the calcium-sensing receptor using calcimimetic or calcilytic agents may allow the anabolic effects of parathyroid hormone to be harnessed to good effect. With all of these therapies, it will be important to assess response in relation to important clinical end points such as fracture.

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“…Side effects included gastric irritation and generalized lower extremity pain. A more recent trial of a slow-release preparation of fluoride showed promise in terms of improved fracture rate and tolerability (110), and fluoride is available in Europe. To date, this drug has not been approved by the FDA in the US.…”

Section: New Therapies Selective Estrogen Receptor Modulators (Serms)mentioning

confidence: 99%

The prevention and treatment of osteoporosis

Golden

1998

Arthritis & Rheumatism

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Treatment of postmenopausal osteoporosis with slow-release sodium fluoride: final report of a randomized controlled trial

Cited by 18 publications

References 0 publications

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

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

Pathogenesis and Prevention of Bone Loss in Patients Who Have Kidney Disease and Receive Long-Term Immunosuppression

The prevention and treatment of osteoporosis

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