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Fosamax Review Article

 

Fosamax basically alters the cycle of bone formation and breakdown in the body. It slows down bone loss while increasing bone mass which helps in preventing bone fractures. It belongs to a group of medicine known as bisphosphonates and it is used in men and women to treat or prevent osteoporosis that is caused by menopause or by taking steroids. Fosamax is also used to increase bone mass in men who have osteoporosis and treat Paget's disease of bone. In case of any surgery, it is necessary to reveal doctor that you are taking fosamax. The medication is only the part of entire exercise which includes diet changes, exercise, taking calcium and vitamin supplements.

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fosamax treats osteoporosisWomen in general, in comparison to men, need to be monitoring their bone density especially as they age. Postmenopausal women are of even greater risk as their bone density greatly begins to decline after menopause. This is due to the loss of estrogen during menopause. The estrogen hormone helps to maintain a certain level of bone density and with its subsequent loss, women can start to experience osteopenia (loss in bone mass) which can lead to osteoporosis (translates to porous bones). Of course, porous bones are weak and more likely to break.

Treatments to improve bone density and hopefully strengthen bones include the drug, Fosamax®, commonly known as alendronate. Alendronate, a bisphosphonate, is an oral drug that can be given at 10 mg a day or 70 mg a week. It has been shown to reduce bone fractures in clinical studies, up to a 40-50% reduction in the risk of vertebral fractures (Lips and van Schoor, 2005). Bisphosphonate operate by inhibiting osteoclasts, cells which break down bone. The further mechanism of bisphosphonates is to bind to bone and inhibit the osteoclast enzyme, farnesyl pyrophosphate synthase. When osteoclasts are inhibited, less bone is broken down, and a possible increase in bone density is possible. Through clinical trials, Fosamax® was found to improve bone density in postmenopausal women that already had osteoporosis.
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One such trail by Ringe and Moller (2009) involved 186 women at or over the age of 50 with postmenopausal osteoporosis. Three study groups were formed and each group was either given generic Alendronate, Fosamax®, or anther bisphosphonate, Actonel®. After treatment with Fosamax® at 70 mg once a week with a supplement of 1,200 mg calcium and 800 IU vitamin D once a day, there was improvement in bone density at the hip and lumbar spine. This improvement was also found in the study group that took Actonel® and generic Alendronate, but a greater effect was found in the groups treated with the non-generic (Fosamax® and Actonel®) than with the generic Alendronate. There was only a 1.5% change in mean bone density in the study participants taking the generic drug, compared to 2.9% and 3.1% change in Fosamax® and Actonel® respectively. Also, the participants taking the generic drug reported more adverse gastrointestinal effects (32 participants) compared to 15 participants taking Fosamax® and 9 participants taking Actonel®.

Another study (Koo et al., 2010), identified the benefits of Fosamax® in conjunction with a vitamin D supplement. Vitamin D is necessary for bone growth and when taken in combination with calcium, may help individuals diagnosed with osteoporosis. Vitamin D doses of 400-800 IUs for people less than 50 years of age and a dose of 800-1000 IUs for those aged over 50 is recommended by the National Osteoporosis Foundation, though the Institute of Medicine does not recommend taking over 800 IUs until 70 years of age (2010).

It may be difficult for some individuals to take such doses on a daily basis, thus a bisphosphonate was combined with a vitamin D supplement, cholecalciferol, to create Fosamax Plus®. This combination may improve calcium absorption and reduce the number of oral supplements to hopefully eliminate the difficulties of taking multiple drugs/supplements for osteoporosis.

Koo et al., (2010) gave weekly supplements of Fosamax Plus® (alendronate 70 mg and cholecalciferol 2,800 IU) to 27 patients (mainly women). Serum levels of vitamin D, parathyroid hormone, calcium, osteocalcin and N-telopeptide levels were measured. In these patients, serum vitamin D levels increased by 77% in the first 3 months and continued to improve over the next 6 months; serum osteocalcin (indicator of bone breakdown) levels decreased by 19% in 6 months and continued at decreased levels at 12 months. The combination drug may also be less associated with hypercalcemia and/or hypercalciuria than Alendronate alone (Recker et al., 2006).

Side effects

The most common side effect, in about 20-30% of users of Fosamax®, is gastrointestinal discomfort. Most of these gastrointestinal effects are associated with esophageal irritation. Other complaints are nausea, heartburn, and upper abdominal pain (Arantes et al., 2010). If gastrointestinal discomfort becomes too much to handle, bisphosphonates can be taken intravenously. The intravenous form of bisphosphonate does not accumulate in the G.I. tract and should cause less G.I. discomfort. Such intravenous forms are Ibandronate, Zoledronic acid, and Pamidronate. Both Ibandronate and Zoledronic acid have been shown to decrease the risk of vertebral and non-vertebral fractures but the risk of hip fractures is still to be evaluated in Ibandronate (Arantes et al., 2010). As of 2010, the FDA has not approved the use of Pamidronate for osteoporosis.
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Flu-like symptoms (headache, fever, bone pain, and nausea) have been shown to occur in patients that have taken intravenous bisphosphonates. These symptoms may just occur in individuals that have never taken bisphosphonates before. Also, kidney problems have been reported in some users of intravenous bisphosphonates and it is recommended to have kidney function assessed before processing with the intravenous dosage (Chang et al., 2003).


Fosamax® may also inhibit serum calcium levels and in patients with already low vitamin D levels, a possibility of contracting hypocalcemia may occur. Serum calcium and vitamin D levels should be measured before using the drug.


Fosamax in the News


One of the rare side effects of Fosamax® is osteonecrosis of the jaw (ONJ), or ‘dead jaw’. This is caused by sores that do not heal usually after dental surgeries. According to Arantes et al. (2010), 95% of the cases that reported osteonecrosis of the jaw were from patients receiving high doses of the intravenous drug during cancer therapy. In 2009, a district court judge in Florida ruled that Merck (the company that produces Fosamax®) should not be charged with punitive damages because of Fosamax association with ONJ. Individuals claimed that Fosamax® caused their ONJ and Merck did not warn patients of this side effect. There was not sufficient scientific evidence to document a causal relationship between Fosamax® and ONJ, so no damages were awarded to the plaintiffs (Moynihan, 2009).

List of references

1. Arantes, H.P., da Silva, A.G., Lazaretti-Castro , M. 2010. Bisphosphonates in the treatment of metabolic bone diseases.
Arq Bras Endocrinol Metab. 54(2): 206-212.

2. Chang J.T., Green L, Beitz J. 2003. Renal failure with the use of zoledronic acid. N Engl J Med 349:1676-9.

3. Compston J., Cooper A., Cooper C., Francis R., Kanis J.A., Marsh D. et al. 2009. Guidelines for the diagnosis and management of osteoporosis in postmenopausal women and men from the age of 50 years in the UK. National Osteoporosis Guideline Group (NOGG). Maturitas. 62(2):105-8.

4. Institute of Medicine, Food and Nutrition Board. Dietary Reference Intakes for Calcium and Vitamin D.
Washington, DC: National Academy Press, 2010.

5. Koo, J.H., Kim, H.K., Kim, I.S., Kim, E.K., and Chung, Y.S. 2010. The Effects of Combined Treatment of Alendronate Plus Active or Plain Vitamin D on the Vitamin D Metabolism and Bone Turnover Markers in Patients with Osteoporosis. Endocrinology and Metabolism 25 (4):305-309.

6. Lips P., van Schoor N.M. 2005. Quality of life in patients with osteoporosis. Osteoporos Int.16:447-55.

7. Moynihan, R. 2009. US judge rules Merck won’t face “punitive damages” in first Fosamax case. BMJ 339:b3225.

8. Recker, R., Lips, P., Felsenberg, D., Lippuner, K., Benhamou, L., Hawkins, F., Delmas, P.D., Rosen, C., Emkey, R., Salzmann, G., He, W., and Santora A.C. 2006. Alendronate with and without cholecalciferol for osteoporosis: results of a 15-week randomized controlled trial. Curr Med Res Opin 2006 Sep; 22(9) :1745-55.

9. Ringe, J.D., and Moller, G. 2009. Differences in persistence, safety and efficacy of generic and original branded once weekly bisphosphonates in patients with postmenopausal osteoporosis: 1-year results of a retrospective patient chart review analysis. Rheumatol Int 30: 213-221.


 

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