The studies found Activella to be effective in preventing bone loss in postmenopausal women compared to the placebo group, based on measurement of various skeletal sites, including the lumbar spine and total hip. It was previously approved by the FDA for the treatment of moderate to severe vasomotor symptoms associated with menopause and for vulvar and vaginal atrophy associated with menopause. Use of the product is restricted to women with an intact uterus. It is characterized by low bone mass and structural deterioration of bone tissue, leading to bone fragility and an increased susceptibility to fractures of the hip, spine and wrist. At menopause, a woman experiences bone loss, which increases her risk for bone fractures.
Bone fractures are a major cause of morbidity and mortality associated with osteoporosis.
Activella will be available in pharmacies by summer 2000. Anyone who has hypersensitivity to any of the components of Activella should not take it. Any question regarding a medical diagnosis, treatment, referral, drug availability or pricing should be directed to either a licensed physician or to the product's manufacturer.