May 16, 2010
It is estimated that greater than 40% of postmenopausal women in the United States will experience one fracture during their lifetime. The quality of life is greatly reduced after osteoporotic bone fracture, and some fractures result in death. Costs associated with these fractures, estimated at greater than $19 billion in 2005, make a sizeable contribution to the overall US medical costs. A number of effective therapies have been developed that include calcium and vitamin D supplementation, hormone replacement therapy, and bisphosphonates (e.g., Fosamax, Alendronate).
Numerous studies and reviews have been conducted to evaluate the anti-fracture nature of bisphosphonates in postmenopausal women. Studies have shown that Fosamax and its generics provide for a positive change in bone mineral density BMD as evaluated in randomized control trials. Although each bisphosphonate provides for different BMD’s depending on dosages, all were successful in preventing fractures. In addition, the site of measuring BMD affects the overall BMD as well. This means that bones in different parts of the body have different results due to the fact they have different structure BMD because they perform different functions, which means results cannot be compared across trials. Alendronate, the generic of Fosamax, has been studied for 10 years; however, some patients were supplemented with calcium and vitamin D and others were not, making comparison difficult due to different treatments. Given these differing treatment regimes, data cannot be easily compared.
Scientific publications on randomized controlled trials, post hoc analyses, and observational studies have been analyzed with a wide range of generics including alendronate (Fosamax), determining efficacy with more than 100 patients, with follow up data for at least one year. The strengths and limitations of each study method have been thoroughly reviewed and reported.
Analysis of controlled trials indicate result differences with different generic forms of bisphosphonates in terms of site-specific fracture prevention and time set of fracture risk reduction. In other words, depending on the generic drug, different bones demonstrate variation on their degree of fracture protection. Some generics have different results where others have similar outcomes. Alendronate demonstrated fracture protection for up to 10 years where other generics were only evaluated for 3-5 years. The only way to get a definitive interpretation is to compare complementary data from trials and observational studies from journals. However, clinical trials and clinical settings, although limited in size, have demonstrated a decrease in fracture risk. The patient exclusion process for these trials and previously reported data is interesting to note. Studies that contained only unique patient subpopulations were excluded as well as patients who had fractures within the first 6 months of treatment. Other studies excluded patients who had combination therapies (generics plus something else) or where drug treatment was changed midstream and patients who had different dosing regimens of the same bisphosphonate.
One may wonder whether the subpopulations that were excluded from these studies might have contained information about Fosamax femur fracture.
If you have experienced a Fosamax femur fracture or any other bone related illness while on Fosamax, you may be entitled to financial compensation. Fosamax femur fracture lawsuits are currently being filed across the country. You may want to contact a Fosamax lawyer to see if you qualify for a lawsuit.
Susan Ardizzoni, Ph.D. holds a Doctorate in Biology with a major in Neuroscience (medical) and minors in Biochemistry, Physics, and Mathematics with experience in basic and clinical research. Although the author is not an attorney, this article was sponsored by the law firm of Bernstein Liebhard LLP and constitutes Attorney Advertising. To learn more about Fosamax femur fracture or Fosamax lawyer please visit www.ConsumerInjuryLawyers.com.