Fosamax (alendronate ) can it be the answer to your bone loss?

One of the first drugs prescribed by my health care provider was Fosamax. Like most post menopausal women, I found that it helped increase my bone density. I did have problems with taking the drug on a daily basis and so stopped. Then a weekly 70mg dose of Fosamx came on the market. I used this for awhile and then stopped.

Fosamax is a powerful drug and I thought you might have some questions about it. I have used the question/answer format again so you can scroll down to find the information that interests you.

1. What is Fosamax and how does it work? Fosamax is the brand name that the drug manufacturer Merck gave to the drug alendronate. It is one of the most commonly prescribed drugs for osteopenia and osteoporosis.

Fosamax works by "inhibiting the work of osteoclats".

Osteoclats are the cells that remove old bone. Fosamax does not affect the work of your osteblats, the cells that build new bone. Since your osteoblats continue to work while your osteoclats are inhibited by the drug, you begin to add bone.

First you stop losing more bone than your cells are making. Then slowly, you begin to add new bone. If you are doing bone desnity exercises and other bone building activitieyou will build new bone faster.

Since it usually takes about 100 days for a full cycle of bone building to occur, it takes about a year to see the results of taking Fosamax.

Research shows that the rate of increase in bone mass usually improves in the 2nd and 3rd year. After the third year, there appears to be little further improvement with Fosamax.

2. How often should one take Fosamax? Are there any cautions when taking it?There are two forms of Fosamx: one is taken each day; the other is taken once a week. The pill needs to be taken in the morning before eating or drinking anything. (No, no coffee or juice. They would interfere with the work of the pill.)

When you take the pill, you need to drink a full glass of water to be sure that the pill ‘goes all the way down’. Then do not lie down for at least 30 minutes. You can sit upright, stand or walk.

After 30 minutes, eat something. After that, you can lie down if you want or need. The reason you can not lie down is that Fosamax can erode the lining of the esophagus and cause ulceration. Staying upright makes sure the pill stays in the stomach when it disintergrates.

3. Should I have any concerns about taking Fosamx [ alendronate ]? If you have any of the following conditions or problems, be sure to discuss them with your health care provider before taking this medication.

- if you have a problem swallowing or have a narrowing of your esophagus
- if you have ulcers on your esophagus or if you have an esophageal disease
- if you have a condition that causes low levels of calcium in your body
- if you have kidney disease
- if you have stomach ulcers or other digestive problems
- if you are unable to stand or sit upright for at least 30 minutes
- if you are pregnant or if you are breast feeding
It is important to discuss these problems with your health care provider because it could be that you should not take Fosamax or if you do take it, you may need a lower dose or some special monitoring.

4. What about the cost? Will my health insurance pay for this medication? Fosamx is not cheap. But since it is an FDA approved treatment for Osteoporosis, most insurance companies will cover the cost. If you do not have insurance, do shop around. Prices vary widely from pharmacy to pharmacy.

Also, Merck has a program to help those who can not afford their medications. Patients can get information about the program through Merck's Consumer toll-free number, 1-800-727-5400. Most patients apply through their health care provider, so do ask yours if you feel that you can not afford your Fosamax prescription.

5. Are their any generic equivalents? Right now there is no generic equivalent available in the United States. Generic forms of the drug are available outside the USA. TEVA, an Israeli company that specializes in developing generic drugs will be able to distribute an generic equivalent in the USA in 2008 since TEVA recently won the court battle with Merck over distribution of generic equivalent.

6. Are there any 'downsides' to taking Fosamax? There are a few. First there is the problem of possible irritation or ulceration of the esophagus or of developing gastric ulcers. If you develop any irritation, do contact your health care provider before taking your next dose. Second, is the cost. Third, since this is a fairly new drug, there are no long term studies of its effects although more studies are being conducted each year.

7. What about Osteonecrosis?

here has been some concern of late about fosamax or other bisphosphonates developing Osteonecrosis - especially of the jaw after dental procedures.

I am including a link to a full text report about Ostenecrosis and bisphosphonates so readers can satisfy their need for knowledge about the condition and risks. Osteocronsis and bisphosphonates

Recent Research about Fosamax

Does Fosamx (aldnronate) reduce fractures? Here are two studies but their conclusions differ:

1. Alendronic acid in primary prevention: new indication. No reduction in fracture risk. Prescrire Int 2000 Jun;9(47):70-2.
Abstract. (1) Alendronic acid at a dose of 5 mg/day is now licensed in France for primary prevention of postmenopausal fractures. (2) The clinical file is relatively bulky and methodologically adequate, but there are no comparisons with combined hormone replacement therapy or with raloxifen. (3) Three trials have shown that 5 mg/day alendronic acid slows postmenopausal bone loss. However, this effect disappears on treatment cessation, and mineral bone density is only one risk factor for postmenopausal fractures. (4) A placebo-controlled trial of primary prevention involving more than 4,000 patients showed no reduction in the risk of fracture after 4 years of treatment with alendronic acid (5 mg/day for 2 years, then 10 mg/day). (5) Alendronic acid increases the risk of oesophageal ulceration, necessitating strict precautions during ingestion.

2. Risk of fracture among women who lose bone density during treatment with alendronate. The Fracture Intervention Trial. by Chapurlat RD, Palermo L, Ramsay P, Cummings SR .Department of Rheumatology and Bone Diseases and INSERM U403, E. Herriot Hospital, 69437, Lyon, France.

It is commonly believed that the response to treatment in patients on alendronate is proportional to the increase in bone mineral density (BMD), and that those who lose BMD during treatment might not respond to treatment. In the Fracture Intervention Trial 6,459 women were randomly assigned to treatment with alendronate or placebo; BMD was measured annually, and new spine fractures were assessed by lateral spine films, taken at baseline and end of follow-up. Among subjects who took at least 70% of the study drug (5,220 women), we compared reductions in risk of spine fractures at end of follow-up (3 or 4 years) within various levels of change in total hip and spine BMD after 1 and 2 years of treatment, after adjustment for differences in characteristics between the treatment and control groups. Women "losing" BMD at the lumbar spine (0% to 4%) while on alendronate had a reduction of 60% in vertebral fracture risk [OR=0.40 (0.16, 0.99)] compared to their counterparts in the placebo group. The few women that lost more than 4% did not have a significant benefit [OR=0.15 (0.02, 1.29)]. Those who "gained" BMD (0% to 4%) during treatment had a reduction in risk of 51% [OR=0.49 (0.30, 0.78)]. Similarly, women who "lost" total hip BMD (0% to 4%) during the first year on alendronate had a 53% decreased risk of vertebral fracture compared to their controls taking placebo [OR=0.47 (0.27, 0.81)], whereas those "gaining" BMD (0% to 4%) had a comparable risk reduction [OR=0.49 (0.34, 0.71)]. This was not observed for the few women who lost more than 4% [OR=0.61 (0.11, 3.45)]. Patients who lost BMD at both the hip and spine were not protected by alendronate. Among patients who adhere to treatment with alendronate, even those who lose BMD benefit from a substantial reduction in risk of vertebral fracture. So, the reduction in bone turnover induced by alendronate might be more important than BMD changes. The few women who lose the most BMD (more than 4% per year) might not benefit from the treatment.

PMID: 15580479 [PubMed - as supplied by publisher]

How does Fosamax compare with other medications?

Treatment with once-weekly alendronate 70 mg compared with once-weekly risedronate 35 mg in women with postmenopausal osteoporosis: a randomized double-blind study. by Rosen CJ, Hochberg MC, Bonnick SL, McClung M, Miller P, Broy S, Kagan R, Chen E, Petruschke RA, Thompson DE, de Papp AE; Fosamax Actonel Comparison Trial Investigators.Maine Center of Osteoporosis Research and Education and St Joseph Hospital, Bangor, Maine 04401, USA.

Once-weekly alendronate 70 mg and once-weekly risedronate 35 mg are indicated for the treatment of postmenopausal osteoporosis. These two agents were compared in a 12-month head-to-head trial. Greater gains in BMD and greater reductions in markers of bone turnover were seen with alendronate compared with risedronate with similar tolerability. INTRODUCTION: The nitrogen-containing bisphosphonates, alendronate and risedronate, are available in once-weekly (OW) formulations for the treatment of postmenopausal osteoporosis. A 12-month, head-to-head study was performed to compare these agents in the treatment of postmenopausal women with low BMD. MATERIALS AND METHODS: A total of 1053 patients from 78 U.S. sites were randomized to OW alendronate 70 mg (N = 520) or risedronate 35 mg (N = 533), taken in the morning after fasting. Endpoints included BMD changes over 6 and 12 months at the hip trochanter, total hip, femoral neck, and lumbar spine (LS); percent of patients with predefined levels of change in trochanter and LS BMD at 12 months; and change in biochemical markers of bone turnover at 3, 6, and 12 months. Tolerability was evaluated by adverse experience (AE) reporting. RESULTS: Significantly greater increases in hip trochanter BMD were seen with alendronate (3.4%) than risedronate (2.1%) at 12 months (treatment difference, 1.4%; p < 0.001) as well as 6 months (treatment difference, 1.3%; p < 0.001). Significantly greater gains in BMD were seen with alendronate at all BMD sites measured (12-month difference: total hip, 1.0%; femoral neck, 0.7%; LS, 1.2%). Significant differences were seen as early as 6 months at all sites. A greater percentage of patients had > or =0% (p < 0.001) and > or =3% (p < 0.01) gain in trochanter and spine BMD at 12 months with alendronate than risedronate. Significantly greater (p < 0.001) reductions in all biochemical markers of bone turnover occurred with alendronate compared with risedronate by 3 months. No significant differences were seen between treatment groups in the incidence of upper gastrointestinal AEs or AEs causing discontinuation. CONCLUSIONS: In this 12-month, head-to-head trial of alendronate and risedronate, given in accordance with the approved OW regimens for treatment of osteoporosis in postmenopausal women, alendronate produced greater gains in BMD and greater reductions in markers of bone turnover than risedronate. The greater antiresorptive effect of alendronate was seen as early as 3 months, and the tolerability profiles were similar.

For additional studies, go to PubMed and enter the term Fosamax in the search box..