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.