MENOSTAR^® (estradiol transdermal system) is indicated for the prevention of postmenopausal osteoporosis. Therapy should be considered only for women at significant risk of osteoporosis. Nonestrogen medications should be carefully considered first.

The mainstays for decreasing the risk of postmenopausal osteoporosis are weight-bearing exercise, adequate calcium and vitamin D intake and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400 to 800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.

Risk factors for osteoporosis include low bone mineral density, low estrogen levels, family history of osteoporosis, previous fracture, small frame (low BMI), light skin color, smoking, and alcohol intake. Response to therapy can be assessed during treatment by measuring biochemical markers of bone formation/resorption, and/or bone mineral density (BMD).

Estrogen therapy reduces bone resorption and retards or halts postmenopausal bone loss. Studies have shown a risk ratio of about 0.4 for hip and wrist fractures in women whose estrogen therapy was begun within a few years of menopause, compared to women taking calcium and vitamin D alone. Studies also suggest that estrogen reduces the rate of vertebral fractures. Even when started as late as 6 years after menopause, estrogen reduces further loss of bone mass for as long as treatment is continued. When estrogen therapy is discontinued, bone mass declines at a rate comparable to the immediate postmenopausal period.

Data from the Women’s Health Initiative study showed that use of estrogen (dose equivalent to 0.625 CE) resulted in about 6 less hip fractures per 10,000 women/years, compared to use of placebo (risk ratio about 0.6).

Contraindications

MENOSTAR should not be used in women with any of the following conditions:

1. Undiagnosed abnormal genital bleeding.
2. Known, suspected, or history of cancer of the breast.
3. Known or suspected estrogen-dependent neoplasia.
4. Active deep vein thrombosis, pulmonary embolism or a history of these conditions.
5. Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction).
6. Liver dysfunction or disease.
7. MENOSTAR should not be used in patients with known hypersensitivity to its ingredients.
8. Known or suspected pregnancy. There is no indication for MENOSTAR in pregnancy. There appears to be little or no increased risk of birth defects from oral contraceptives in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy.