Prevention of tooth loss by the administration of alendronate or

Drug – bio-affecting and body treating compositions – Dentifrices

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514108, 514900, 514902, A61K 716, A61K 3166, A61K 3342

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active

059140992

DESCRIPTION:

BRIEF SUMMARY
DESCRIPTION OF THE INVENTION

This invention relates to a method of preventing tooth loss by the administration of alendronate or a pharmaceutically acceptable salt thereof.


BACKGROUND OF THE INVENTION

Alendronate, 4-amino-1-hydroxybutylidene- 1,1-bisphosphonic acid, and its pharmaceutically acceptable salts are known to be useful in the treatment of osteoporosis. See, for example U.S. Patent 4,621,077. It has also been used experimentally to treat alveolar bone loss associated with periodontitis and periodontal disease, as set forth in U.S. Pat. No. 5,270,365.
Alveolar bone of the mandible and maxilla serves as the primary foundation for tooth support. While alveolar bone is generally subject to metabolic and other systemic diseases of the skeleton, there has been relatively little work on the occurrence, progression, or impact of systemic osteoporosis on alveolar bone, although such a relationship may exist. Mandibular bone loss has been correlated with systemic bone loss, and it has been reported that tooth loss is exacerbated by osteoporosis.
Osteoporosis of the jaw may have a relationship to tooth loss. Alveolar maxillary bone and mandibular bone may be highly susceptible to osteoporosis in those who have already lost teeth, either due to disuse or changing mechanical forces. Osteoporosis of the maxilla is accompanied by an increase in size of the paranasal sinuses, which in dentate persons can cause the maxillary antrum to extend below the roots of posterior teeth, possibly causing severe referred pain in these teeth, tooth mobility, and increased periodontal pocketing. The latter can in turn, lead to loss of crestal bone and tooth loss. If teeth are lost, many persons are now receiving dental implants, prostheses anchored by metal pillary in alveolar bone. Success of this process may also depend in part on the structural integrity of the bone.
Further it has been suggested that there is a relationship between periodontal disease and osteoporosis. However, it has not been shown that compounds which can treat osteoporosis may be effective in preventing tooth loss which is not associated with periodontal disease.


DETAILED DESCRIPTION OF THE INVENTION

This invention relates to a method of preventing tooth loss not necessarily associated with periodontal disease in a human by administering an effective amount of alendronate, or a pharmaceutically acceptable salt thereof over an extended time.
It has been found, in accordance with this invention that administration of alendronate or a pharmaceutically acceptable salt thereof to patients can result in fewer patients who experience tooth loss, as compared with patients who have not received alendronate. Further, in accordance with this invention, administration of alendronate can result in fewer numbers of teeth lost in patients receiving alendronate and who experience tooth loss, as compared with patients who do not receive alendronate. Thus another aspect of this invention is a method of lessening the risk of tooth loss by administering alendronate or a pharmaceutically acceptable salt thereof.
For purposes of this specification and claims, the following definitions apply: than three years. salt thereof) required to either (a) prevent progression of osteoporosis in the mandible or maxilla so that less tooth loss occurs than in the absence of alendronate; or (b) prevent osteoporosis from occurring in the mandible or maxilla so that less tooth loss occurs than in the absence of alendronate.
In accordance with this invention, alendronate may be given to patients who are either suffering from osteoporosis or who do not have this underlying disease.
It may be helpful to administer alendronate or its pharmaceutically acceptable salt for an extended time in order for the beneficial effects to occur. This is particularly so for patients who are already experiencing osteoporosis, i.e. have a bone mineral density (BMD) less than about 2.0 standard deviations below the normal peak BMD. Thus, in one aspect of this invention, alendronate is administered to osteo

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Krook et al., Cornell Vet. vol. 62 (1972), pp. 371-376, "Human periodontal disease and osteoporosis".
Groen et al., J. Periodontol., vol. 39 (1978), pp. 19-23, "Chronic destructive periodontal disease in patients with presinile osteoporosis".
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