COMPOSITIONS AND METHODS FOR INHIBITING BONE RESORPTION

Disclosed are compositions and methods for preventing, inhibiting, reducing and treating conditions and diseases associated with abnormal bone resorption in mammals, including for example osteoporosis. Embodiments of compositions of the invention comprise a pharmaceutically effective amount of alend...

Ausführliche Beschreibung

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Bibliographische Detailangaben
1. Verfasser: KIRSCH, JOHN D
Format: Patent
Sprache:eng ; spa
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Zusammenfassung:Disclosed are compositions and methods for preventing, inhibiting, reducing and treating conditions and diseases associated with abnormal bone resorption in mammals, including for example osteoporosis. Embodiments of compositions of the invention comprise a pharmaceutically effective amount of alendronate and vitamin D3 suitable for once-weekly dosing. Compositions and methods of the invention provide vitamin D nutrition during bisphosphonate treatment to facilitate normal bone formation and mineralization while minimizing the occurrence of or potential for the complications associated with vitamin D insufficiency, such as hypocalcaemia and osteomalacia. Also disclosed are methods for manufacturing compositions of the present invention, for measuring stability and degradation of those compositions, and for measuring blood plasma levels of vitamin D. Se describen composiciones y metodos para prevenir, inhibir, reducir o tratar condiciones y enfermedades asociadas con resorcion osea anormal en mamiferos incluyendo, por ejemplo, osteoporosis; las modalidades de las composiciones de la invencion, comprenden una cantidad farmaceuticamente efectiva de alendronato y vitamina D3 adecuada para dosificacion una vez por semana; las composiciones y los metodos de la invencion proveen nutricion de vitamina D durante el tratamiento con bisfosfonato, para facilitar la formacion y mineralizacion normal de hueso, mientras se reduce al minimo la ocurrencia de las complicaciones asociadas con insuficiencia de vitamina D, o el potencial para las mismas, tales como hipocalcemia y osteomalacia; se describen tambien metodos para fabricar composiciones de la presente invencion, para medir la estabilidad y la degradacion de esas composiciones, y para medir los niveles de vitamina D en plasma sanguineo.