Key Findings - Fluoride & Osteomalacia:

1) One of fluoride's more well-defined effects on bone tissue is it's ability to increase the osteoid (unmineralized bone) content of bone. Osteomalacia is a bone-softening disease caused by an excess amount of osteoid in bone.

2) In human clinical trials, where fluoride has been used as an experimental drug to treat osteoprorosis, osteomalacia is a well recognized side effect of fluoride therapy.

3) In the 1960s and 1970s, when dialsysis units did not filter fluoride out of the dialysate, the use of fluoridated water caused an increase in both the rate and severity of osteomalacia among dialysis patients.

4) Among humans with skeletal fluorosis, osteomalacia is one of the more common radiological findings - particularly among children (aka rickets).

5) In studies on fluoride-exposed animals - dating back to the early years of the 20th century - osteomalacia has been a repeatedly-observed bone lesion.

General Info - Osteomalacia:

"A softening of the bones in adults caused by a failure of the normal calcification."
SOURCE: HealthCentral

"Osteomalacia is a type of metabolic bone disease in which the essential problem is a lack of available calcium or phosphorus (or both) for mineralization of newly formed osteoid."
SOURCE: Wheeless' Textbook of Orthopaedics

"There are numerous causes of osteomalacia. In children, the condition is called rickets and is usually caused by a deficiency of vitamin D."
SOURCE: National Institutes of Health

Symptoms - Osteomalacia:

"Diffuse bone pain, especially in the hips; muscle weakness; bone fractures with minimal trauma."
SOURCE: National Institutes of Health

"Patients generally complain of easy fatigability, malaise, and bone pain; Pain is diffuse and poorly localized and is accompanied by a general tenderness of bones; Fractures in an elderly individual that is thought to be the result of osteoporosis may be first sign of osteomalacia, & these patients must be evaluated carefully; Muscular weakness is often seen in severe cases"
SOURCE: Wheeless' Textbook of Orthopaedics

"The pain of osteomalacia is typically difficult to localize. All the bones are tender—especially the long ones in the legs and arms... In diagnosed cases of osteomalacia, 94% of patients complain of pain; 94% complain of muscle weakness; 88% complain of bone tenderness with pressure on touch; 24% complain of a waddling gait and muscle cramps; and, there is a higher incidence of fracture than expected for age—even in bones that test “normal” on the DEXA bone density test."
SOURCE: Doctor Diet

Frequency - Osteomalacia:

"The incidence is 1 in 1000 people."
SOURCE: HealthCentral

"Incidence/Prevalence in USA: N/A."
SOURCE: MedFamily

"Osteomalacia is more common than most physicians realize and should always be considered in patients with unexplained pain..."
SOURCE: Doctor Diet

"In adults, osteomalacia is usually a disease of the older population (50-80)."
SOURCE: MedFamily

Synonyms - Osteomalacia:

Rickets (when present in children).

Human Clinical Trials - Fluoride & Osteomalacia: (back to top)

"[F]luoride therapy is not considered to be a therapeutic agent for bone in part because of its side effects of high incorporation of fluoride ion in bone and the associated osteomalacia."
SOURCE: Lau KH, et al. (2002). Bone cell mitogenic action of fluoroaluminate and aluminum fluoride but not that of sodium fluoride involves upregulation of the insulin-like growth factor system. Bone 30: 705–711

"The prevalence of osteomalacia was much higher with high-dose NaF (sodium fluoride group) (42.8% for generalized, 85.7% for any) than with low-dose NaF (3.8% for generalized, 7.7% for any). With low-dose NaF, osteomalacia only developed in patients who were not taking vitamin D at the time of the second biopsy..."
SOURCE: Balena R, et al. (1998). Effects of different regimens of sodium fluoride treatment for osteoporosis on the structure, remodeling and mineralization of bone. Osteoporosis International 8: 428-435.

"[T]his study clearly documents in a prospective manner that fluoride therapy results in osteomalacia... Definitive evidence for osteomalacia is a prolonged mineralization lag time, which following fluoride treatment was found to be increased 9-fold in the second biopsy and 4-fold in the third biopsy."
SOURCE: Lundy MW, et al. (1995). Histomophometric analysis of iliac crest bone biopsies in placebo-treated versus fluoride-treated subjects. Osteoporosis International 5:115-129.

"True osteomalacia existed in... two patients with mild impairment of renal function. This points out the harmful effect of even mild renal failure in fluoride-treated patients."
SOURCE: Orcel P, et al. (1990). Stress fractures of the lower limbs in osteoporotic patients treated with fluoride. Journal of Bone and Mineral Research 5(Suppl 1): S191-4.

"Cancellous osteoid volume and perimeter, as well as width of osteoid seams, were significantly increased in fluorotic patients... Eight (fluoride-treated) patients showed a true histological osteomalacia with both a significantly increased osteoid width and a significantly decreased mineral apposition rate."
SOURCE: Boivin G, et al. (1989). Skeletal fluorosis: histomorphometric analysis of bone changes and bone fluoride content in 29 patients. Bone 10:89-99.

"When fluoride is given, especially at a high dosage without calcium, osteomalacia may develop. The newly formed matrix may be abnormal and may not undergo adequate mineralization. Thus, a typical histomorphometric picture is represented by a pronounced increase in osteoid (nonmineralized matrix) and reduced calcification front."
SOURCE: Pak CY. (1989). Fluoride and osteoporosis. Proceedings of the Society for Experimental Biology and Medicine 191: 278-86.

"In our patient, fluoride therapy induced typical bone fluorosis: elevated bone fluoride level (5,100 ppm), abornmal bone pattern on microradiography and an osteomalacia-like picture on histological examination."
SOURCE: Van Linthoudt, Ott H. (1987). Supraacetabular and femoral head stress fracture during fluoride treatment. Gerontology 33:302-306.

"True clinical osteomalacia can be induced by fluoride in the right circumstances, as a direct side effect of fluoride."
SOURCE: Kleerekoper M. (1983). Surgeon General's Ad Hoc Committee on 'Non-Dental Health Effects of Fluoride." Transcript of Proceedings, National Institutes of Health, Bethesda, Maryland, April 19.

"Combinations of osteomalacia, osteoporosis, and osteosclerosis (in fluorosis) result in a spectrum of bone changes from an early age."
SOURCE: Christie DP. (1980). The spectrum of radiographic bone changes in children with fluorosis. Radiology 136:85-90.

"Fluoride alone leads to accumulation of unmineralised bone, producing the histological picture of osteomalacia. The addition of calcium or vitamin D, or both, is believed to prevent this complication. We report a case where osteomalacia developed during sodium fluroide treatment despite large doses of vitamin D..."
SOURCE: Compston JE, et al. (1980). Osteomalacia developing during treatment of osteoporosis with sodium fluoride and vitamin D. British Medical Journal 281: 910-1.

Patients with Kidney Disease using Dialysis with Fluoridated (1 ppm) water: Fluoride & Osteomalacia: (back to top)

NOTE: For more detailed information on fluoridation & diaylsis, click here

"[O]steomalacia was significantly more severe in the fluoridated group."
SOURCE: Johnson W, et al. (1979). Fluoridation and bone disease in renal patients. In: E Johansen, DR Taves, TO Olsen, Eds. Continuing Evaluation of the Use of Fluorides. AAAS Selected Symposium. Westview Press, Boulder, Colorado. pp. 275-293.

"The risk of severe osteomalacia is reduced with the use of fluoride-free dialysate."
SOURCE: Lough J, et al. (1975). Effects of fluoride on bone in chronic renal failure. Archives of Pathology 99: 484-487.

"Because we had not seen such severe bone disease in a patient while on relatively high concentrations of dialysate calcium when fluoride-free water had been employed, we recommended in October, 1968, that a commercial mixed-bed deionizer be installed to remove the fluoride.. Bone resorption decreased and osteomalacia improved, coincident wtih the lowering of dialysate, serum and bone concentrations of fluoride... The excessive amounts of osteoid seen in the bone biopsy specimen and the decrease in osteomalacia subsequent to correcting the deionizer operation are consistent with a fluoride effect."
SOURCE: Johnson WJ, Taves DR. (1974). Exposure to excessive fluoride during hemodialysis. Kidney International 5: 451-454.

"The markedly increased incidence of osteomalacia in the fluoridated group supports previous reports that fluoride is an important factor... Since our patients in the fluoridated group were living in widely separate areas with different water supplies it seems unlikely that there was another common factor other than fluoride responsible for the higher incidence of osteomalacia. It is possible that the presence of other substances in untreated water is necessary before the toxic effects of fluoride become manifest... Forty-one patients on our chronic hemodialysis program were assessed for the degree of progression of bone disease over a period of 46 months. Four of 7 patients using fluoridated water (in diaylsis) developed florid osteomalacia, as opposed to none of the 34 patients in the non-fluoridated group... We conclude that the presence of fluoride in the dialysate, perhaps in conjunction with other substances, is associated with an increased incidence of osteomalacia. It therefore seems prudent to use non-fluoridated water in long-term hemodialysis."
SOURCE: Cordy PE, et al. (1974). Bone disease in hemodialysis patients with particular reference to the effect of fluoride. Transactions of the American Society of Artifical Internal Organs 20: 197-202.

"The use of fluoride-free dialysate decreases the risk of severe morphologic osteomalacia."
SOURCE: Jowsey J, et al. (1972). Effects of dialysate calcium and fluoride on bone disease during regular hemodialysis. Journal of Laboratory and Clinical Medicine 79: 204-214.

"We conclude that the osteomalacia that occurs in dialysis patients is due to multiple factors that are removed by deionization. Fluoride may be one of the contributing factors."
SOURCE: Posen GA, et al. (1972). Comparison of renal osteodystrophy in patients dialyzed with deionized and non-deionized water. Transactions of the American Society for Artificial Internal Organs 18: 405-411.

Skeletal Fluorosis: Fluoride & Osteomalacia: (back to top)

"Heavy and prolonged consumption of tea may be capable of inducing fluoride-related osteomalacia manifesting as unexpected spontaneous bone fractures."
SOURCE: Hayem G, Ballard M, Palazzo E, Somogyi N, Roux F, Meyer O. (2004). Insufficiency bone fractures due to fluorosis in heavy tea drinkers. Annals of the Rheumatic Diseases 63(Suppl 1): 488.

"Skeletal fluorosis caused by endemic fluorine poisoning was once thought to result merely in osteosclerosis, causing marblelike changes. Later, various radiologic features were found, including osteosclerosis, osteomalacia, and osteoporosis. Although this disorder has a wide variety of appearances, little attention has been given to the spectrum of radiologic appearances."
SOURCE: Wang Y, et al. (1994). Endemic fluorosis of the skeleton: radiographic features in 127 patients. American Journal of Roentgenology 162:93-8.

"High F intakes have been associated wtih a wide spectrum of bone diseases including osteosclerosis, osteoporosis, osteomalacia and exostoses... The pathogenic mechanisms underlying fluorosis of the mineralizing tissues have been studied extensively, but are still a matter of controversy."
SOURCE: Kragstrup J, et al. (1989). Effects of fluoride on cortical bone remodeling in the growing domestic pig. Bone 10:421-424.

"Osteomalacia and osteoporosis may occur in older persons who ingest excessive fluorides (over 10-25 mg/d for 10-20 years)."
SOURCE: Ellenhorn MJ, Barceloux DG. (1988). Medical Toxicology: Diagnosis and Treatment of Human Poisoning. Elsevier; New York. pp. 534.

"It is evident that osteomalacia is a feature of fluorosis, particularly in children and young males."
SOURCE: Krishnamachari KA. (1986). Skeletal fluorosis in humans: a review of recent progress in the understanding of the disease. Progress in Food and Nutrition Sciences 10(3-4):279-314.

"Metabolic bone disease occurred more frequently in residents of endemic (fluorosis) areas than in residents of nonendemic areas whose nutritional status was comparable. Common metabolic bone disorders, associated with endemic skeletal fluorosis, were osoteoporosis (bone resorption), rickets, osteomalacia, and parathyroid bone disease."
SOURCE: Teotia SPS, et al. (1984). Environmental fluoride and metabolic bone disease: an epidemiological study (fluoride and nutrient interactions). Fluoride 17: 14-2.

"Some cases showed axial osteosclerosis exclusively, others axial osteosclerosis in association with peripheral osteoporosis or osteomalacia."
SOURCE: Daijei H. (1984). Further observations on radiological changes of endemic foodborne skeletal fluorosis. Fluoride 17: 9-14.

"The osseous changes in fluorosis have been described as osteosclerosis, exostosis, hyperostosis, osteoporosis, osteomalacia, and rickets. Many questions arise as to why sometimes one type of osteopathy is induced and another at other times."
SOURCE: Krook L, Maylin GA. (1979). Industrial fluoride pollution. Chronic fluoride poisoning in Cornwall Island cattle. Cornell Veterinarian. 69(Suppl 8): 1-70.

Animal Studies: Fluoride & Osteomalacia: (back to top)

"Our study also demonstrated evidence of osteomalacia in rats receiving 15 ppm fluoride, or the equivalent of 3 ppm fluoridated water for humans."
SOURCE: Turner CH, et al. (1996). High fluoride intakes cause osteomalacia and diminished bone strength in rats with renal deficiency. Bone 19:595-601.

"The effect of fluoride on bone appears to be one of increased turnover with matrix formation exceeding resorption. Mineralization of newly-formed matrix is imperfect and much of the bone appears as woven or immature bone with components of unmineralized matrix resembling osteomalacia."
SOURCE: Riggins RS, et al. (1974). The effects of sodium fluoride on bone breaking strength. Calcified Tissue Research 14: 283-289.

"The osteofluorotic lesions may be porosis, sclerosis, hyperostosis, osteophytosis, and malacia, depending on the interacting factors influencing the degree of fluorosis."
SOURCE: Shupe JL, Olson AE. (1971). Cinical aspects of fluorosis in horses. Journal of the American Veterinary Association 158: 167-174.

"The changes produced in experimental animals... have been described as resembling osteomalacia by Roholm (1937), osteoporosis by Kellner (1939) and osteomalacia and rickets by Bauer (1945)."
SOURCE: Faccini JM. (1969). Fluoride and bone. Calcified Tissue Research 3:1-16.

"a small number of studies in animals and in man have indicated that osteomalacia is the prevailing response to administration of fluoride."
SOURCE: Jowsey J, et al. (1968). Some results of the effect of fluoride on bone tissue in osteoporosis. Journal of Clinical Endocrinology 28:869-874.

"Very high levels of fluoride resulted in severe osteomalacia."
SOURCE: Johnson LC. (1965). Histogenesis and mechanisms in the development of osteofluorosis. In: H.C.Hodge and F.A.Smith, eds : Fluorine chemistry, Vol. 4. New York, N.Y., Academic press. 424-441.

"The effects of fluorine on the osseous system are complicated, which may explain some of the apparently contradictory experimental observations. Both diffuse sclerosing processes, and a generalized condition resembling osteomalacia are observed."
SOURCE: Roholm K. (1937). Fluoride intoxication: a clinical-hygienic study with a review of the literature and some experimental investigations. London: H.K. Lewis Ltd.

"For practical reasons the bone affection resulting from the severe fluorine intoxication, accompanied by general symptoms, has been called osteomalacia... Common features are the reduced strength of the bones, the tendency to form exostoses, bone atrophy, and a deficient calcification."
SOURCE: Roholm K. (1937). Fluoride intoxication: a clinical-hygienic study with a review of the literature and some experimental investigations. London: H.K. Lewis Ltd.

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