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Osteo drug with Vit. D gets BFAD ok
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The Bureau of Food and Drugs (BFAD) has recently granted approval to pharmaceutical company Merck Sharp & Dohme (MSD) to market alendronate/ cholecalciferol, the first and only treatment that contains a weekly dose of two therapies – alendronate, a drug used for osteoporosis treatment, and vitamin D (cholecalciferol) – in a single, once-weekly tablet.

Vitamin D inadequacy is widespread in post-menopausal women with osteoporosis regardless of geographic location.

Recent epidemiological studies conducted in North America, Latin America, Europe, the Middle East, Asia and the Pacific Rim have shown that more than 50 percent of post-menopausal women with osteoporosis have inadequate levels of vitamin D.

Another recent study found that 97 percent of patients hospitalized with a non-traumatic fracture, such as a minor fall from a standing height, have vitamin D inadequacy.

"Vitamin D plays a vital role in bone health. Without vitamin D, the body cannot absorb calcium, which is essential for the normal development and maintenance of strong, healthy bones in people with osteoporosis," said Dr. Mary Anne Lim-Abrahan, professor, Section of Endocrinology, Department of Medicine, University of the Philippines’ College of Medicine, and president, Philippine Lipid Society.

Vitamin D is generally recommended for all patients being treated for osteoporosis. "Most patients know that calcium is important, but do not realize that vitamin D is essential for calcium absorption and building strong, healthy bones to help prevent fractures. Patients need to be reminded about the important role of Vitamin D in maintaining optimal bone health to help prevent fractures," said Dr. Lim-Abrahan. "As physicians, we always explain to our patients diagnosed with osteoporosis the importance for them to take vitamin D regularly."

Study results show that the alendronate in original formulation and alendronate/cholecalciferol were equally bioavailable.

Alendronate/cholecalciferol is indicated for the treatment of osteoporosis in post-menopausal women to prevent fractures, including those of the hip and spine, and to help ensure vitamin D adequacy.

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