Because it contains alendronate
as the active ingredient, the clinical effects of Binosto for the treatment of osteoporosis
are based on the results of studies that used regular alendronate tablets. Binosto itself has not been studied in clinical trials.
Several studies have demonstrated that alendronate is effective at increasing bone mineral density (a measure of bone mass, which is commonly used to evaluate the health of bones) and decreasing the risk of bone fracture in postmenopausal women. In these studies, the drug was shown to reduce the risk of a new vertebral fracture (broken spinal bone) by as much as 48 percent. Increases in bone mineral density were seen in the hip and spine, areas where osteoporosis commonly occurs.
Alendronate has also been shown to increase bone mineral density in the spine and hip of men with osteoporosis. In addition, the drug helped prevent loss of height in both men and women with osteoporosis, which can be a consequence of the disease.
It should be noted that the safety and effectiveness of alendronate is based on clinical studies that evaluated the drug for no longer than four years of use. Bisphosphonates, including Binosto, settle into bone and are gradually released from the bone over many years. It is not entirely known how long treatment is needed for optimal bone effects.
An analysis completed by the U.S. Food and Drug Administration (FDA) suggested that many people may be able to stop treatment after three to five years and still maintain beneficial effects. However, there appears to be certain groups of individuals who may benefit from longer use, including those who still have low bone mineral density after three to five years of treatment, and those at particularly high risk for fracture.
Talk to your healthcare provider about how long you should take Binosto. In general, your healthcare provider will need to reevaluate your need for ongoing treatment on a regular basis, as each person's situation may be different.