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This article is from the WebMD News Archive
No Osteoporosis Drug Proven Best
Dec. 17, 2007 -- There is no proof that the most widely prescribed osteoporosis drugs work better than other drug treatments for the prevention of bone fractures.
That is the finding from a new report funded by the U.S. government's Agency for Healthcare Research and Quality (AHRQ).
Based on an analysis of studies examining the risks and benefits of six bisphosphonates and other osteoporosis drugs, researchers concluded that while many medications reduced the risk of bone fractures in people with osteoporosis, no single drug or drug class was clearly superior.
They noted that there was not enough data to determine if the bisphosphonates were better for preventing fractures than hormone-based treatments.
The popular osteoporosis drugs Fosamax and Boniva are bisphosphonates, which work by slowing the natural process that breaks down bone tissue.
The researchers included in their analysis studies involving Fosamax, Boniva, four other bisphosphonates (Didronel, Aredia, Actonel, and Reclast), the man-made hormone calcitonin, the selective estrogen receptor modulators Evista and tamoxifen, parathyroid hormone, estrogen, testosterone, calcium, and vitamin D.
"The fact is, there have been very few head-to-head trials done to compare any of these agents," study author Catherine MacLean, MD, PhD, of the RAND Corp., tells WebMD. "It is expensive to do these trials. On the other hand, these are also expensive agents, and as consumers we have the right to know which ones work best."
Many Patients Stop Treatment
The studies indicated that the effectiveness of calcium and vitamin D varied according to the dosage taken, how often the supplements were taken, and whether osteoporosis patients were at high risk for fractures.
Researchers also found compliance to be a problem with most osteoporosis treatments and for calcium and vitamin D, which must be taken every day. Patients were more likely to stay on longer-acting bisphosphonate treatments than those that had to be taken daily.
At least one calcium study showed the supplement to benefit patients who took it daily as directed, but not patients who took it less often than was recommended, MacLean points out.
"As with any therapy, these treatments don't work unless you take them," she says.
No single bisphosphonate was found to be superior to another for preventing bone fractures.
The analysis was published online Monday and will appear in the Feb. 5 edition of the Annals of Internal Medicine.
More Study Needed
An official with the AHRQ says the report helps shed light on what is known and not known about the effectiveness and safety of osteoporosis treatments.
"Without question we need more studies examining the effectiveness of different treatments," Jean Slutsky tells WebMD. "There is a lot of uncertainty about how the supplements compare to the other therapies and how the [prescription] drugs compared to each other."
This research is important, Slutsky says, because so many people elderly people are at risk for osteoporosis and frequently life-altering fractures related to bone weakening.
"About half of women over 50 will suffer an osteoporosis-related bone break in their lifetime," she says. "We have all heard stories about older people who were doing great until they fell and broke a hip and went into a steady decline."
She adds that while it isn't clear which medications work best, it is clear that most treatments do help reduce fracture risk when taken regularly.
"[Osteoporosis] is a largely treatable condition," she says.
Calls to Fosamax manufacturer Merck & Co. and Boniva manufacturer Hoffmann-LaRoche were not returned by publication time.
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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.
Taking Vitamin D and Calcium Together
Osteoporosis specialist Dr. Ethel Siris on why it's so important to take calcium with Vitamin D.
