Menopause and Osteoporosis

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After menopause, women may develop osteoporosis, a condition in which bones gradually lose their mineral content, becoming porous, thin and fragile. Osteoporosis causes pain, bone fractures and loss of stature in its advanced stages. While not specifically a menopausal symptom, osteoporosis is a significant health hazard associated with menopause because of decreased estrogen levels. To increase estrogen levels and strengthen bones, some women choose hormone replacement therapy (HRT). But for women who can't or don't want to use HRT, a growing number of medications are available to help fight osteoporosis. These medications are reviewed in detail in Menopause: Questions You Have ... Answers You Need. Written by PMS editor Annette Thevenin Doran, the book, available in January, also answers your questions on other aspects of menopause, including menopausal symptoms and treatments, the role of nutrition and exercise and the pros and cons of HRT. In this excerpt, adapted for Newsletter readers, we focus on osteoporosis medications.

Q: What medications prevent osteoporosis?
A: Medications to prevent osteoporosis include salmon calcitonin, bisphosphonates, calcitriol, sodium fluoride and a new class of medications known as selective estrogen receptor modulators, or SERMs. Let's start with salmon calcitonin, which is commonly called calcitonin and is sold under the brand names Calcimar and Miacalcin (available as an injection and nasal spray). Calcitonin, a type of hormone that stimulates bone production, is approved by the Food and Drug Administration (FDA) to prevent further bone loss in postmenopausal women who already have osteoporosis. Calcitonin helps strengthen bone by steering calcium into it and slows bone resorption (the body's process of removing calcium from bones). Calcitonin also apparently decreases pain caused by vertebral fractures from osteoporosis.

Q: Does calcitonin have any side effects?
A: Possible side effects include allergic reactions, headache, dizziness, increased frequency of urination and abnormal fluid accumulation. Nasal irritation is the most commonly reported side effect of Miacalcin Nasal Spray.

Any woman with an allergy to salmon should have an allergy test done before taking salmon calcitonin for the first time. In some cases, it can cause a severe, life-threatening allergic reaction.

Q: What are bisphosphonates?
A: Bisphosphonates are a class of drugs that can prevent further bone loss. However, except for alendronate sodium (Fosamax), bisphosphonates are not approved by the FDA for this use. (Bisphosphonates are used to treat bone cancer and other bonerelated conditions.) They work by reducing bone resorption.

Q: What does Fosamax do?
A: According to the manufacturer, Fosamax prevents osteoporosis in postmenopausal women. Results after two years of the ongoing six-year Early Postmenopausal Interventional Cohort study showed that treatment with Fosamax stopped bone loss in most women. Women treated with the drug significantly increased bone mass at the lumbar spine and hips by about 3.5 and 1.9 percent, respectively.

The FDA approved Fosamax for the treatment of osteoporosis in postmenopausal women in September 1995. In April 1997, the FDA approved the drug for the prevention of osteoporosis in postmenopausal women and the prevention of fractures in postmenopausal women who already have osteoporosis.

Q: Are there any drawbacks?
A: Yes. Fosamax carries very specific directions for administration: when to take it (time of day and proximity to mealtimes), what fluid to take it with and how much, and what protocol to observe after taking it. If these directions are not followed, upper-gastrointestinal problems can result. For best results, women should take Fosamax 30 minutes before breakfast (on an empty stomach) and avoid lying down afterward.

In addition, women with abnormalities of the esophagus, low levels of calcium in their blood or severe kidney disease or anyone unable to sit or stand upright for at least 30 minutes should not take Fosamax. Other side effects may include irritation and inflammation or ulceration of the esophagus.

Q: What are some other bisphosphonates?
A: Etidronate (Didronel) and pamidronate (Aredia) are two bisphosphonates that are injected into the body. Etidronate is also available in pill form and appears to prevent and treat osteoporosis of the spine. According to studies, pamidronate is effective in the treatment of postmenopausal osteoporosis and can increase bone mass and significantly reduce the frequency of new vertebral fractures. Again, though, these are drugs that have yet to be approved by the FDA specifically for the prevention and treatment of osteoporosis. However, your doctor can prescribe them "off label" for that purpose.

Q: What is calcitriol?
A: Calcitriol (Rocaltrol) is a potent form of vitamin D and a regulator of calcium. It appears to be an effective medication for osteoporosis, at least according to preliminary studies. Writing in The Osteoporosis Handbook, Sydney Lou Bonnick, M.D., says, "Studies have demonstrated that calcitriol can increase calcium absorption and increase the bone mass in the spine and forearm."

Q: What does sodium fluoride do for osteoporosis?
A: Once a mainstay of treatment for advanced osteoporosis and widely used for more than 30 years, this drug has fallen out of favor in the United States. Studies suggest that while sodium fluoride increases bone density in women who take it, it doesn't reduce the number of fractures.

However, new attention is being focused on this drug. A slow-release sodium fluoride, developed by researchers at the University of Texas Southwestern Medical School at Dallas, is awaiting approval by the FDA for the treatment of osteoporosis. A study published in the Annals of Internal Medicine found that women who combine slow-release sodium fluoride with calcium citrate supplements gain bone density in the spine and reduce their risk of future spine fractures.

Q: Are there any other medications to prevent osteoporosis?
A: Yes. In December 1997, the FDA approved a new drug, raloxifene (sold as Evista), that helps protect the bones and possibly the heart. Raloxifene belongs to the new class of drugs known as SERMs. Also called a designer estrogen, raloxifene has the selective ability to act on many of the organs that estrogen does, but not the uterus and the breasts. Raloxifene doesn't cause the monthly bleeding or breast tenderness associated with estrogen replacement, and early data suggest that raloxifene doesn't increase the risk of uterine or breast cancer.

Raloxifene acts like estrogen on the bones by building bone density. But it seems to prevent bone loss less effectively than estrogen does, according to various reports. The drug's manufacturer, Eli Lilly, says raloxifene maintains bone and keeps it strong in most women. It is not known if raloxifene prevents fractures, however.

Q: What are some possible side effects?
A: Raloxifene may worsen some menopausal symptoms. Women who take raloxifene have a higher incidence of hot flashes and leg cramps than women taking estrogen. Like estrogen, raloxifene may increase the risk of developing blood clots in the lungs and legs. Long-term risks are unknown.

Nevertheless, raloxifene may prove useful for a woman who shouldn't go on estrogen replacement therapy but who still wants some protection for her bones and possibly for her heart. A final note: At about $65 per month, this new drug costs roughly twice as much as estrogen replacement therapy.

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