Osteoporosis, the most prevalent bone disease in the U.S., can lead to bone loss and an increased risk of fractures. Over 12 million Americans over the age of 50 have osteoporosis and another 32 million have low bone mass. Osteoporosis is especially common in women after menopause, but also occurs in older men. Most often, it is due to an increase in the rate of resorption (breakdown) of bone tissue that is not matched by the rate of bone formation. The risk of having an osteoporosis-related fracture increases with age. In fact, one out of every two women over age 50 will have an osteoporosis-related fracture in their remaining lifetime, with the risk of fracture increasing with age.

 

Merck & Co, Inc. announced today that the US Food and Drug Administration (FDA) has approved FOSAMAX PLUS D (alendronate sodium/cholecalciferol). FOSAMAX has been demonstrated to reduce the risk of both hip and spine fractures in postmenopausal women with osteoporosis and is now the only bisphosphonate with the added benefit of a weekly dose of vitamin D.

Maintaining adequate levels of vitamin D is necessary for the development of strong bones because it helps increase the intestinal absorption of calcium. Vitamin D insufficiency is associated with reduced calcium absorption, bone loss, and increased risk of fracture. Patients at increased risk for vitamin D insufficiency  and with gastrointestinal malabsorption syndromes should receive vitamin D supplementation in addition to that provided in FOSAMAX PLUS D.

 

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.

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 severe kidney disease or low levels of calcium in their blood, in patients who are allergic to FOSAMAX PLUS D or in patients who are pregnant or nursing. FOSAMAX PLUS D alone should not be used to treat vitamin D deficiency.

 

 

The standard dosing regimen for FOSAMAX PLUS D includes swallowing the tablet with six to eight ounces of plain water the first thing upon arising for the day and at least 30 minutes before the first food, beverage or medication of the day. After swallowing FOSAMAX PLUS D, patients should not lie down for at least 30 minutes and not until after consuming their first food of the day. Patients should not chew or suck on a tablet of FOSAMAX PLUS D.