Osteoporosis Health Center
This article is from the WebMD News Archive
Forteo Helps Drug-Induced Osteoporosis
Nov. 14, 2007 -- A new study shows that in people at high risk for bone fracture due to steroid-related osteoporosis, the drug Forteo may trump Fosamax.
The study included 428 people with osteoporosis tied to long-term use of steroids such as prednisone to treat other conditions. Over time, some steroids can cause bone loss.
All of the patients took a pill and got a shot every day for 18 months.
Half of the patients got Fosamax and a shot containing no medicine. The other half of the group got an empty pill and a shot of Forteo.
The patients didn't know whether they were taking Forteo or Fosamax. All of them also took calcium and vitamin D.
Participants got bone density scans of their hip and lumbar spine periodically throughout the study.
After 18 months of treatment, patients in the Forteo group had a 7% increase in their lumbar spine bone mineral density and a 3.8% increase in their total hip bone mineral density.
People taking Fosamax showed smaller gains, with a 3.4% increase in lumbar spine bone mineral density and a 2.4% increase in their total hip bone mineral density.
Of the 11 people who suffered a spine fracture during the study, 10 were taking Fosamax and one was taking Forteo.
The researchers -- who included Kenneth Saag, MD, of the University of Alabama at Birmingham -- report similar safety profiles for each drug.
But a journal editorial notes that the study is due to continue for another 18 months, and those results aren't in yet.
Editorialist Philip Sambrook, MD, of Australia's University of Sydney also notes that the study only included "the group most severely affected by [steroid]-induced bone loss and the most difficult to treat."
The study, published in tomorrow's edition of The New England Journal of Medicine, was funded by Eli Lilly, which makes Forteo.
In the journal, Saag reports financial ties to Eli Lilly and to Merck, which makes Fosamax. Sambrook notes no potential conflicts of interest.
Merck spokeswoman Kim Hamilton tells WebMD that Merck doesn't have an immediate comment but looks forward to reviewing the study.
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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.


