Osteoporosis Health Center
Guidelines for Osteoporosis Treatment
Sept. 15, 2008 -- Drugs are helpful in treating osteoporosis, but figuring out which drug to prescribe means evaluating the pluses and minuses of each option for each patient, according to new recommendations from The American College of Physicians.
As people get older their bones become less dense and more vulnerable to fracture. In its severe form, this condition is known as osteoporosis. Osteoporosis is particularly common in women after menopause, though men get it too.
The American College of Physicians makes these news recommendations:
- Doctors should offer drugs to people who have known osteoporosis and people who have experienced what's called a fragility fracture -- when a bone breaks without significant trauma.
- Doctors should consider preventive treatment for patients at risk of getting osteoporosis, the guidelines say.
- Doctors should take into account a patient's individual risk and benefits when selecting among drug treatment options for osteoporosis
- Additional research should be done to investigate osteoporosis treatment in men and women.
The authors collectively reviewed data from several different drug studies to come up with their evidence-based guidelines.
Among the findings:
- Bisphosphonates are used for prevention or treatment of osteoporosis. They reduce fractures, but there isn't good information on how long people should take these drugs. Adverse effects include acid reflux, and problems of the esophagus; a rare but serious side effect involves the breakdown of the jaw bone.
- Estrogens reduce the incidence of fractures but can increase risk for some kinds of cancer, stroke, and blood clots.
- A non-estrogen drug that focuses on estrogen receptors (also known as a SERM, or selective estrogen receptor modulator) prevents spinal fractures but doesn't reduce the likelihood of a hip fracture. Adverse effects include blood clots.
- Calcitonin is used for treatment. The authors note fair-quality evidence that it reduces incidence of spine fractures, though evidence suggests calcitonin does not reduce other kinds of fractures. No clinically significant side effects are noted in the guideline.
- Teriparatide is used for osteoporosis treatment. It prevents spine fractures, but evidence for other types of fractures are mixed. No clinically significant side effects are noted in the guideline.
- Vitamin D and calcium supplements, taken together, have a modest effect on fractures. It is unclear how effective either is if taken alone.
VIVELLE-DOT (estradiol transdermal system) IS AVAILABLE BY PRESCRPTION ONLY.
INDICATION
Vivelle-Dot is used after menopause to: reduce moderate to severe hot flashes; treat moderate to severe dryness, itching and burning in or around the vagina; help reduce your chances of getting osteoporosis (thin weak bones); and treat certain conditions in which a young woman's ovaries do not produce enough estrogens naturally. Vivelle-Dot 0.025 mg/day is only used to prevent osteoporosis from menopause. If you use Vivelle-Dot only to treat your dryness, itching, and burning in and around your vagina or if you use Vivelle-Dot only to prevent osteoporosis from menopause, talk with your healthcare professional about whether a different treatment or medicine without estrogens might be better for you.
IMPORTANT SAFETY INFORMATION
Estrogens increase the chances of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb).
Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer, and blood clots. Using estrogens with progestins may increase your risk of dementia (decline in memory and thinking skills).
Vivelle-Dot should not be used if you have unusual vaginal bleeding; currently have or have had certain cancers, including cancer of the breast or uterus; had a stroke or heart attack in the recent past (for example, in the past year); currently have or have had blood clots; currently have or have had liver problems; or think you may be, or know that you are, pregnant.
The most common side effects that may occur with Vivelle-Dot are headache, breast tenderness, and back pain.
You and your healthcare professional should talk regularly about whether you still need treatment with Vivelle-Dot.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Full Prescribing Information for Vivelle-Dot.


