Merck & Co., Inc. announced that the US Food and Drug Administration has approved a new dosage of Fosamax Plus D (alendronate sodium/cholecalciferol), a single, once-weekly tablet containing Fosamax (alendronate sodium) 70 mg and 5,600 international units (IU) of vitamin D3 (cholecalciferol).

"This once-weekly medicine now contains both the well-documented fracture benefits of Fosamax as well as 5,600 IU of vitamin D3. This provides physicians with another option to manage9 their osteoporotic patients, many of whom are not getting enough vitamin D3," said Robert Heaney, MD, professor of medicine, Creighton University, Omaha, Nebraska. "The importance of vitamin D3 for postmenopausal women with osteoporosis has been recently highlighted by the updated recommendation from the National Osteoporosis Foundation (NOF) for increased vitamin D intake."

NOF calls for increased vitamin D intake for Americans over 50. The NOF recently updated its recommendations for calcium and vitamin D intake, advocating for 800-1,000 IU of vitamin D3 per day for adults over 50. Consistent with these recommendations, Fosamax Plus D (70 mg alendronate/5,600 IU vitamin D3) is now the appropriate dose for most postmenopausal patients with osteoporosis being treated with Fosamax Plus D. Patients at increased risk for vitamin D deficiency (e.g., those who are nursing-home bound, chronically ill, over the age of 70 years) or with gastrointestinal malabsorption syndromes may require vitamin D supplementation in addition to that provided in Fosamax Plus D (70 mg/5,600 IU).

Fosamax Plus D is indicated for the treatment of osteoporosis in postmenopausal women. For the treatment of osteoporosis, Fosamax Plus D increases bone mass and reduces the incidence of fracture, including those of the hip and spine. Fosamax Plus D is also indicated to increase bone mass in men with osteoporosis. It is the only bisphosphonate with a weekly dose of vitamin D3, as per the NOF guidelines.

Fosamax Plus D, like other bisphosphonate containing products, should be used with caution in people with certain stomach or digestive problems. Fosamax Plus D should not be used if the patient has certain disorders of the esophagus that delay emptying or if the patient is unable to stand or sit upright for at least 30 minutes. In addition, Fosamax Plus D should not be used in patients with low levels of calcium in their blood or in patients who are allergic to Fosamax Plus D, and is not recommended for use in patients with severe kidney disease or in patients who are pregnant or nursing. Fosamax Plus D alone should not be used to treat vitamin D deficiency.

Nearly two out of three women over 50 are not getting enough vitamin D According to an analysis published in 2004 and based on the Third National Health and Nutrition Examination Survey (NHANES III), a majority of Americans do not receive enough vitamin D. The analysis estimated that over 70 per cent of women age 51-70 and almost 90 percent of women over 70 are not getting an adequate intake of vitamin D from food and supplements.

"It is clear that adequate levels of vitamin D are required for normal bone formation and most patients with osteoporosis need to find ways to get more," added Dr. Heaney.