If you are a menopausal or post-menopausal woman, you may have been told by your physician that you should begin taking bisphosphonates–better known under the brand names Fosamax, Actonel, Boniva, Skelid, Didronel, and others. Several years ago it was recommended that I take Actonel after I was diagnosed with osteopenia based on a heel bone density test. I did some research before deciding what to do. The information I found then did not convince me that I should take any of the bone loss drugs. Although I no longer have access to that exact information, I remember reading that there was little evidence that the drugs prevented broken bones in women who had not already had fractures, and I had not. I also read that broken bones correlated most strongly with falling, not to whether or not the patient was taking drugs. After reading about the most common side effects–upset stomach, irritation of the esophagus, and bone or joint pain–and the very small likelihood of preventing broken bones, I decided that the potential benefits did not justify the risk of side effects, and I did not take the Actonel.
Just recently I was talking to a friend whose doctor had told her that she should begin taking one of these bone loss drugs. Our discussion of the pros and cons made me think I should take another look at the latest research about bisphosphonates, which are prescribed to millions of people. What I learned confirmed my earlier decision not to take Actonel and gave me reason to doubt the benefits for many others now taking the drugs. Here’s what I found, why I’m glad I decided not to take Actonel years ago, and why I would absolutely make the same decision today.
What are osteoporosis and osteopenia?
First I looked for more information about osteoporosis and osteopenia–exactly what are they and how do doctors diagnose them? Osteoporosis comes from the Greek for ‘porous bones.’ It indicates a reduced mineral density of the bone (BMD) that can lead to breakage. Bone cells die and new ones are created, but as we age the creation of new bone cells slows down which can reduce bone density. The information about osteoporosis was about what I expected, but what I then learned about osteopenia did surprise me. Osteopenia, sometimes called pre-osteoporosis, is officially and arbitrarily defined as “one standard deviation below that of an average 30-year old white woman.” This definition is controversial because there is “no biological or medical reason for using one standard deviation.” [emphasis mine] It was defined in 1992 by the World Health Organization and was intended to indicate a possible growing problem. The definition of osteopenia “didn’t have any particular diagnostic or therapeutic significance.” So why are so many women diagnosed with osteopenia and told to take bisphosphonates? In fact, more than half of the population probably qualifies as having osteopenia. Another problem with the diagnosis is that the methods of testing for both osteoporosis and osteopenia are not very reliable, and the diagnosis itself may depend more on what type of machine is used for the test than on the actual condition of your bones. Bisphosphonates are heavily marketed to women who are diagnosed with osteopenia and who are actually at very low risk of fracture. Another interesting (but not so surprising) bit of information: the original bisphosphonate drug trials were funded by the pharmaceutical industry and were reviewed by teams that included drug company employees. Is this another case of drug companies exaggerating risks of a disease in order to market their drug treatments? [Another example, statins for lowering cholesterol]
Men can also have osteoporosis–about 30% of osteoporosis fractures–are in men-but, due to their greater bone mass, men usually break hips, vertebra, or wrists about 10 years later than women.
What causes osteoporosis and osteopenia
The primary causes of osteoporosis are poor bone growth in adolescence and increased bone loss in perimenopausal women; however, there are other factors that can reduce bone strength. Some are lifestyle habits like smoking tobacco, drinking too much alcohol, and lack of weight-bearing exercise. Another cause is a diet poor in nutrients such as the Standard American Diet (SAD) which doesn’t have the nutrients needed for healthy bones and teeth, such as vitamins A, D, K, B vitamins, omega-3 fatty acids, and minerals. In fact, any condition or illness that prevents or hinders our getting nutrients from the foods we eat can cause bone loss. Some of these conditions are (in addition to the SAD) anorexia nervosa and other eating disorders, celiac disease, inflammatory bowel disease, Chron’s disease, liver disease, and excessive weight loss. The common practice of feeding dairy cattle grain rather than grass may also contribute to bone loss since today’s conventional dairy milk has only about 30% of the conjugated linoleic acid (CLA) that it had before 1960. CLA has many health benefits, including increase in bone mineral density. Many Americans take multiple prescription drugs every day, and lots of these medications can cause bone loss: antacids containing aluminum; some antiseizure medications such as Dilantin or Phenobarbital; cancer chemotherapy drugs; cyclosporine A; cortisone and prednisone; gonadotropic releasing hormone; heparin; lithium, Depra-Provera, methotrexate; proton-pump inhibitors; SSRIs such as Lexapro, Prozac, and Zoloft; Tamoxifen; Thiazolidenediones, Actos and Avandia; and an excess of thyroid hormones.
What are bisphosphonates and how do they work?
Bisphosphonates are a class of drug that are designed to prevent bone loss. Bisphosphonates originated in the detergent division of Procter & Gamble in the 1960s when the company was looking for an additive that could be used to soften water. Soon however the dental division took over the research to help remove tartar buildup on teeth. The discovery that bisphosphonates could stop bone loss led to the release of Fosamax (alendronate) by Merck in the 1990s. Our bones are constantly undergoing turnover which is kept in balance by osteoblasts which create bone and by osteoclasts which destroy bone. Bisphosphonates cause the osteoclasts to slow way down or die thus reducing bone loss. During treatment, the bisphosphonates accumulate in the bones and can persist for decades, continually exposing patients to the effects of the drugs long after they stop taking them.
Are bisphosphonates effective for osteoporosis and osteopenia?
There is evidence that bisphosphonates reduce the risk of breakage in patients who have had previous fractures; however, they have not been shown to reduce fracture risk for those who have not already had a fracture. Studies of Fosamax, a commonly prescribed bisphosphonate, show that, for women with osteoporosis, it “may prevent fractures in the spine, hip or wrist, or in bones other than the spine.” However, in women with more normal bone density, as in osteopenia, Fosamax shows no benefit in fractures of the hip, wrist, or bones other than the spine. For women with osteopenia, Fosamax may prevent fractures of the spine. Studies of Actonel, another commonly prescribed bone drug, showed that for women with osteoporosis, it could prevent spinal fractures and may prevent hip fractures, but will not prevent wrist fractures. The Actonel studies do not show any benefit for women who are diagnosed with osteopenia. Overall it looks like there is some limited benefit for women with osteoporosis and very little, if any, benefit for women with more normal bone strength. How small is the potential benefit for women diagnosed with osteopenia? “Up to 270 women with pre-osteoporosis (osteopenia) might need to be treated with drugs for three years so that one of them could avoid a single vertebral fracture.” [emphasis mine] Even in cases where benefit may be gained from taking the drugs, an analysis published by the FDA “found little if any benefit from the drugs after three to five years of use.”
What are the risks and the most common side effects of taking bisphosphonates?
Since the benefits of taking the drugs seem to be limited, what are the health risks? Are they worth the small but possible benefit? The most common adverse side effects from oral bisphosphonates are upset stomach; inflammation of the esophagus; severe bone, joint, or musculoskeletal pain; atrial fibrillation; bone abnormalities; and osteonecrosis of the jaw. Although the correlation has not been confirmed, one study estimated that 3% of atrial fibrillation cases may have been caused by use of alendronate (Fosamax). The side effect of musculoskeletal pain has been described as severe and even incapacitating and can occur soon after beginning the treatment or years after starting the bisphosphonates. Stopping treatment doesn’t always give complete relief from the pain, maybe because the drugs remain in the bones for so many years.
Femoral (thigh bone) fractures, an uncommon but serious and well-known side effect of taking bisphosphonates, are termed “low-energy or spontaneous” because they result from falls no higher than a standing person or without any fall or trauma at all. Fractures of the thigh bone are rare because the bones are subject to high stress and don’t readily break unless there is really something significantly wrong with the makeup of the bone. How bisphosphonates cause the femoral fractures is not known, but one possibility is that the drugs slow down bone turnover allowing increased mineralization of the bone. This increased mineralization makes the bones stiffer and more brittle. The stiffer bones may cause microscopic cracks that the bones would normally repair; however, if bone resorption (death of bone cells) is inhibited by treatment with bisphosphonates, the normal repair process may not be able to take place. The unrepaired, now more brittle thigh bone may break more easily than normally repaired bone.
When bisphosphonates are administered intravenously, additional adverse side effects can occur. There can be fever, flu-like symptoms, and osteonecrosis (bone death) of the jaw. Osteonecrosis can occur when the bisphosphonates work too well. The drugs inhibit bone cell death which can cause the bones to become too dense. Too dense bones can displace the space for the bone marrow which keeps the bones alive.
What are natural alternatives to taking drugs?
If you decide, like I did, not to take bisphosphonates, there are natural and effective alternatives to taking drugs. These alternatives include exercising, improving your diet, and possibly taking supplements.
First, Exercise is essential. Any type of movement is good for strengthening bones. When muscles contract, they pull the tendons attached to the bones and send a message to the bones to deposit more calcium thus strengthening the bones. The best exercise for osteoporosis is weight lifting–join a gym or get some barbells to use at home. Walking 30 minutes or more a day is basic exercise to improve your overall health. But don’t forget there are many other excellent ways to get your exercise: gardening, dancing, running, jumping rope, tennis, aerobics, and climbing stairs are just some of them. They’re all good. In fact, the best advice is to do whatever activity you enjoy most because that’s the one you will keep on doing.
Second, What you eat and drink can have a profound effect on your health, including your bone strength. Here are some of the changes you can make to help prevent or reverse bone loss. Stop eating and drinking junk foods. Some junk foods just displace nutritious foods in our diet, but others are actually harmful to bone health. Don’t drink soft drinks (the phosphorus promotes bone loss), foods and beverages containing fluoride, caffeine, and alcohol. Stop smoking. Add whole Real Foods to your diet. Studies suggest that our bodies are better nourished by eating foods rich in minerals and vitamins than by taking supplements. Minerals especially important for bone health include calcium, magnesium, and trace minerals like boron, strontium, manganese, silica, and copper. Nutrient-dense foods include cheese and other full-fat dairy products (preferably unpasteurized), wild salmon, sardines, fish liver oils (e.g., fermented cod liver oil), beef liver, egg yolks, and bone broth. Natto (a fermented soybean product), cheeses, egg yolks, and liver are good food sources of vitamin K2 which has been shown in Japanese studies to reverse bone loss in people with osteoporosis. The Japanese studies found K2 supplements caused a 60% reduction in spinal fractures and an 80% reduction in other fractures.
Third, If you find it difficult to eat enough nutritious foods, you can add supplements, although they are not as beneficial as getting nutrients from whole foods. Multi vitamins and minerals, including trace minerals, from good sources may be useful. Fermented cod liver oil is an excellent source of vitamins A and D and omega-3 fatty acids.
What do I do to keep my bones strong?
Since I decided that I would not take drugs for osteopenia, I thought it was important to focus on healthy ways to prevent bone loss. Here’s what I do: I exercise six days a week, at home; I don’t go to a gym. The exercises include using free weights, stretching, Chi Kung, and sometimes Tai Chi. I have eliminated all soft drinks, all processed food, most sweeteners, and most junk food. [We do eat out once or twice a week which I usually put in the junk food category.] My family eats grass-fed beef, pastured or organic poultry, mostly local and/or organic vegetables and fruits, whole raw milk products, and yard eggs. I eat probiotics, such as kefir, kombucha, or fermented fruits and vegetables with every meal. We have greatly reduced, but not eliminated, grains, and the grains we do eat are sprouted or soaked to reduce the toxins and improve digestion. We eat bone broth and lots of homemade soups made with bones. I do take vitamin and mineral supplements (including fermented cod liver oil for A and D and high vitamin butter oil for K2) because my diet in childhood and adolescence was so poor that I’m sure I have deficient bone strength.
Commonly prescribed bisphosphonates, their generic names, and their manufacturers
Fosamax, alendronate, Merck
Actonel, risedronate, Proctor & Gamble
Boniva, ibandronate, Roche
Skelid, tiludronate, Sanofi
Didronel, etidronate, Procter & Gamble
Reclast and Zometa, zoledronic acid, Novartis [intravenously administered]
Aredia, pamidronate, Novartis [intravenously administered]
Update November 22, 2012: Osteoporosis Myth: The Dangers of High Mineral Density explains how a “desease,” osteopenia was manufactured from the normal bone loss due to aging. If someone’s bone density is compared to his/her appropriate age group, the vast majority of people (usually women) “diagnosed” with osteopenia will fall out of the category. An additional problem with measuring bone mineral density (BMD) is that it is NOT a measure of bone strength. In some cases of high bone density, the bone is actually weaker, not stronger. Also, higher BMD in middle-aged and older women is associated with a 200-300% higher risk of breast cancer.
Update, December 5, 2012: A new study has found that “Women with higher cholesterol levels have significantly higher bone mineral density.”
Update, May 9, 2013: “A new study published in The Breast Journal, authored by researchers at the Department of Surgery, St. Luke’s-Roosevelt Hospital Center, New York, NY confirms numerous past studies showing low bone mineral density lowers the risk of breast cancer.” [source]
Update, July 6, 2013: A new study identifies the harmful effects of statins and bisphosphonates on bone health, Statins and Bisphosphonates Inhibit Menaquinone-4 Biosynthesis in Bone
Update, September 4, 2014: A new Swedish study finds that taking bisphosphonates can risk fractures of the thigh bone. “For those who took bisphosphonates for four to five years, the so-called ‘relative risk’ was 100 times higher than among people who didn’t use the medications.” While the risk may be worth the benefit for people with osteoporosis, for those with less decrease in bone density (sometimes called osteopenia), the risk may be greater than the potential benefit. [emphasis added]
Update, September 15, 2014: Vitamin B12 is necessary for proper bone growth. “Older women with low levels of vitamin B12 experience significantly more rapid hip bone loss – a sign of osteoporosis – than women with higher levels of B12.” “The best dietary sources of vitamin B12 are animal products like organic grass-fed beef, chicken, raw milk, and eggs.” [source]
How Bisphosphonates Work
New Cautions About Long-Term Use of Bone Drugs
Bisphosphonates for Osteoporosis–Where Do We Go from Here?
Subtrochanteric and Diaphyseal Femur Fractures in Patients Treated with Alendronate
US FDA Safety Announcement (10-13-2010)
Severe Pain with Osteoporosis Drugs
The Bisphosphonate Story From Detergents to Bone Disease (a history of the development of bisphosphonates in the treatment of osteoporosis)
Alendronate [Fosamax] for the primary and secondary prevention of osteoporotic fractures in postmenopausal women
Risedronate [Actonel] for the primary and secondary prevention of osteoporotic fractures in postmenopausal women
Preventing Osteoporosis with Nutrition
Drugs for pre-osteoporosis: prevention or disease mongering?
Low-Energy Femoral Fractures Associated with the Long-Term Use of Bisphosphonates
Osteochemonecrosis of jaws and bisphosphonates
t10c12-CLA maintains higher bone mineral density during aging by modulating osteoclastogenesis and bone marrow adiposity
Other Causes of Bone Loss
Osteoporosis–Natural Help for Strong Bones
Osteoporosis Prevention Through Nutrition and Diet
Strontium Treatment for Osteoporosis
Preventing Osteoporosis with Nutrition
Photo credit: Alendronic acid (Fosamax) tablets
This post is shared on Fat Tuesday, June 19, 2012