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Bone Loss Shots Fight Osteoporosis
Oct. 13, 2003 -- Women may soon have a new alternative to taking a pill every day to help prevent the bone loss associated with menopause. A new study shows a shot of an experimental drug every three months may be just as good as daily tablets for aiding in osteoporosis prevention.
Researchers found quarterly shots of the drug ibandronate given to postmenopausal women without osteoporosis produced similar bone-loss preventative benefits as those provided by daily drug therapy.
Ibandronate is part of a class of drugs used in osteoporosis prevention known as bisphosphonates. Other bisphosponates include Fosamax and Actonal. These drugs are commonly prescribed in pill form to be taken once a day by postmenopausal women who have osteoporosis or who are at risk or develop it.
But researchers are now investigating new, intravenous forms of these and other drugs administered at less frequent intervals to make it more convenient for women to keep up with their osteoporosis prevention therapy.
Osteoporosis is a bone-weakening disease that frequently strikes women after menopause. The disease makes the bones less dense and susceptible to potentially disabling fractures in the spine and hip as well as other bones.
Quarterly Shots Help Prevent Osteoporosis
In this study, researchers looked at the safety and effectiveness of giving different dosages of ibandronate via injection once every three months to a group of 629 postmenopausal women without osteoporosis.
The study showed that one year's worth of quarterly treatment with ibandronate produced similar gains in bone mineral density (BMD, a measure of bone strength) in the spine and hip as is typically found with daily bisphosphonate therapy.
The 2.0-milligram dose produced an average 2.5% increase in lumbar spine BMD and a 1.7% increase in BMD at the hip compared with those who received a placebo. This dosage level also produced the greatest benefits in normalizing the rate of bone turnover, a process where new cells may not keep up pace with the resorption of old bone leaving bone porous and fragile. Bone turnover is a factor that contributes to the development of osteoporosis.
The results of the study appear in the October issue of the Annals of Rheumatic Diseases.
Researchers say the protective effects of ibandronate in osteoporosis prevention were seen regardless of the women's BMD at the start of the study or time since menopause. But the effects of the therapy were most evident in women at risk for osteoporosis -- women with slight degrees of bone loss not sufficient enough to qualify as having osteoporosis but not considered to have normal bone mineral density measures either.
The most common side effect of treatment with ibandronate was body aches, which was usually minor and reported after the first injection.
Researchers say it's the first study to demonstrate the effectiveness and safety of intermittent intravenous injections of a bisphosphonate in preventing bone loss in early menopausal women.
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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.
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