JustCare

Tag: Osteoporosis

  • Exercise may be your best bet for bone health, not calcium or vitamin D supplements

    Exercise may be your best bet for bone health, not calcium or vitamin D supplements

    Calcium helps keep your bones strong and healthy. So, it is wise to incorporate foods with calcium into your daily diet. If you’re not getting enough calcium, exercise may be your best bet for bone health; the evidence is weak that calcium supplements will benefit you.

    The National Institutes of Health recommends eating foods rich in calcium. People over 50 need between 1,200 mg and 2,000 mg of calcium every day. You can get your daily dose of calcium from milk, cheese, yogurt, soybeans and dark, leafy vegetables such as kale or broccoli.

    Calcium supplements are another matter. Increasing evidence suggests that all those years of advice to take calcium supplements for bone health may be turning into one of those reversals of medical advice that seems to come all too frequently.

    Since 2002, the bulk of the evidence indicates that calcium supplements actually don’t decrease fracture risk and may actually do harm, such as increase the risks of kidney stones, heart attacks, prostate cancer, and even stroke. Nor does evidence indicate that eating more foods with calcium reduces fracture risk.

    That said, the Mayo Clinic suggests that if you are a vegan, lactose intolerant, have osteoporosis, or consume a lot of food with protein or sodium, you should talk to your doctor about whether you should take a calcium supplement.

    Vitamin D supplements also seem to be over-rated as far as bone health, as supplements do not lower fracture risk for those living in the community. For those living in nursing homes on the other hand, they do lower the risk of fractures from falls.

    The best bet to promote bone health for those living in the community? According to the evidence: Exercise. Weight-bearing exercises, such as walking, climbing stairs and dancing, are most helpful. These exercises help create new bone tissue, strengthening your bones.

    Exercise has a positive effect on preventing fractures, though in actual controlled studies, the average effect was small. The Surgeon General recommends an exercise goal of 30 minutes a day.

    This post was originally published on July 30, 2015.

    Here’s more from Just Care:

  • If Merck knew that Fosamax causes bone fractures and kept silent, shouldn’t it be liable?

    If Merck knew that Fosamax causes bone fractures and kept silent, shouldn’t it be liable?

    How would you feel if you were harmed by a medicine you took as prescribed and then learned that the drug company wasn’t liable — even though it knew about the risk and didn’t tell you or your doctor?

    This is exactly what has happened in the case of Fosamax (alendronate), a drug used to treat bone-thinning osteoporosis and osteopenia. After it was approved by the Food and Drug Administration and women across the country began taking the drug, the FDA and its maker, Merck, started receiving reports about spontaneous fractures of the thigh bone among women taking the drug.

    These fractures, dubbed “Fosamax fractures,” happen with no warning and usually require surgery. Although they are a rare side effect of the drug, millions of women have taken the drug. While the true number of Fosamax fractures isn’t known, about 500 women have sued Merck for failing to warn them about the risk of this painful and possibly debilitating side effect. These lawsuits are at the heart of a case, Merck, Sharp & Dohme Corp. v. Doris Albrecht, et al., that will be argued before the U.S. Supreme Court on Jan. 7, 2019.

    MedShadow Foundation, the nonprofit organization I founded in 2012 to inform the public about the side effects of medicines, along with three former FDA officials, filed an amicus curiae brief in support of Albrecht, the defendant in the case. Such “friend of the court” briefs are filed by individuals or organizations that aren’t parties in a case.

    Merck Admits Fosamax Caused The Fractures

    Merck acknowledges that Fosamax caused these fractures and that the company knew about them. In 2008, Merck started the process to get the FDA’s permission to put a warning on the drug label — the inserts that come with all medicines, providing information such as instructions on how to take a drug, what it can be used for, and warnings. The FDA reviews and must approve any information on drug labels for accuracy. These labels are generally considered fair warning to users about possible side effects or adverse events and, in that way, provides legal protection for drug companies from being sued for causing them.

    The FDA relies on manufacturers to update and make changes to drug labels throughout the lives of their drugs. That’s because approvals for new drugs are often based on small clinical trials of 1,000 or fewer people that normally last less than a year. Unusual or rare side effects and can’t be detected in such small, short-term trials. Once a drug is approved and thousands or millions of people are taking it, new side effects and adverse events can emerge.

    The spontaneous fractures caused by Fosamax didn’t begin appearing until the drug had been on the market for five years. And these fractures aren’t the only significant bone problems linked to the drug. Cases of osteonecrosis (literally “bone death”) of the jaw, a painful condition where jaw bones become exposed, were reported by people taking Fosamax. In 2013, Merck agreed to pay $27.7 million to settle 1,140 lawsuits from individuals who alleged that Fosamax caused them to develop this condition.

    Pharmaceutical companies have the best access to reports of adverse events, and they pay attention to updating drug labels as an important patient-protection safeguard.

    When Merck applied to the FDA for a label change to reflect these fractures, the FDA rejected its request. Why? Because Merck described them as stress fractures, which are minor and quite different from far more serious spontaneous fractures. A stress fracture is an incomplete bone break that is generally treated by rest and inactivity. A spontaneous fracture is a complete break that occurs in a seemingly normal bone without any trauma and must often be repaired with surgery.

    Although drug companies are responsible for updating labels, the FDA can require updates. In 2010, the FDA convened a panel to review the increasing number of reports of Fosamax-related spontaneous fractures. After reviewing the research, the panel found a clear connection between Fosamax and spontaneous thigh bone fractures. The FDA then ordered Merck to change the label.

    Women Suing Merck Claim Drugmaker Failed to Warn Them

    The women suing Merck claim that the company failed to warn them about a known adverse event. Merck is claiming that the FDA did not allow the company to change the label, making it impossible for Merck to warn women or their doctors.

    If Merck prevails, the disingenuous tactic it used for Fosamax could be replicated by other pharmaceutical companies and have far-reaching effects.

    Suppose a pharmaceutical company discovers that one of its drugs causes a serious adverse event. The company files an application for a change to the drug label, but knowingly designs the change so the FDA won’t accept it — either by minimizing the risk of the adverse event or by not accurately reflecting the risk. The drug company could then claim it isn’t liable for not warning consumers about that adverse event because the FDA denied the label change.

    If the Supreme Court allows drug companies to circumvent the law this way — which is what Merck is attempting to do in this case — it would remove the motivation for pharmaceutical companies to provide the FDA with timely and transparent information.

    MedShadow Foundation is a small nonprofit with limited resources. Yet we have taken on the costly and time-consuming process of filing an amicus brief because we believe that pharmaceutical companies cannot be allowed to obscure the risks, side effects, and adverse events of drugs — or exaggerate their benefits.

    The foundation’s mission is to protect quality of life by ensuring that people have all the known information about side effects before deciding to take a prescription or over-the-counter drug. Today, pharmaceutical companies are motivated to reveal previously unknown risks and warn the medical community so they can’t be sued for damages. The FDA and the law must maintain that obligation to protect people from unnecessary harm.

    There will always be some risk with medicines, but consumers have the right to all the information about benefits and risks of drugs — whenever that information is discovered — so they can make informed decisions about their health and well-being.

    This article originally appeared on Stat and is also on Medshadow.org.

    Here’s more from Just Care:

  • Do you need a bone scan?

    Do you need a bone scan?

    I want to talk today about bone scans . Here’s my basic advice: for the 40 million people with osteoporosis, this test is critical to diagnose and start treatment. It is good to develop a bone density baseline, but there is generally no reason to do it until you’re at least 65. It’s recommended for women over 65 and those under 65 only if they have a fracture or arthritis or family history or other indications that demonstrate a need for a scan. Men over 70 should consider the test if there is an indication such as, steroids or low testosterone, for it. (Medicare covers a bone scan every two years for people at risk of osteoporosis with a referral from your doctor.)

    Unless the test shows evidence of osteoporosis or serious bone loss or you have other indications, you should be able to avoid scans in the future. You shouldn’t get your bone density tested repeatedly if there’s no evidence you need it. If test results show minimal bone loss, also called osteopenia, you might want to forgo repeated scans.

    As you age, it’s natural to suffer some bone loss. Osteopenia has a much lower risk of fractures than osteoporosis and since bone density does not change rapidly, you probably can wait to get scanned again. Similarly, medication generally should not be taken to treat osteopenia. These drugs can carry some risks (as does any medication) and, the clinical benefit for those with osteopenia appears minor at best.  Moreover, medications can be costly and lengthy.

    So, if you are diagnosed with osteopenia and your doctor recommends regular bone scans or medications, you should ask your doctor whether you can avoid them. Medications alone could cost you between $38 and $148 each month, depending upon whether you take the generic or brand-name drug.

    Instead of undergoing extra tests and getting another prescription, focus on how you can influence your health and reduce your chance of these and other tests. Make sure your diet is balanced and contains Calcium and Vitamin D. Avoid excessive drinking and smoking and medications that promote bone loss. Perform weight-bearing exercises. Finally, make your house and work safe by removing fall hazards.

    Here’s more from Just Care:

  • Osteoporosis, bisphosphonates and how to keep your bones strong

    Osteoporosis, bisphosphonates and how to keep your bones strong

    Bisphosphonate drugs, such as Fosamax, are marketed heavily to older adults as a medicine that keeps your bones strong, particularly for people with osteoporosis. Like all drugs, bisphosphonates have side effects. It’s important to know who benefits from bisphosphonate drugs before deciding to take one.

    Bisphosphonate drugs treat osteoporosis by decreasing the breakdown (resorption) of bone that is part of bone’s normal remodeling process but that speeds up with age. The FDA approved the first bisphosphonate, Fosamax or alendronate, in 1995. These drugs are marketed heavily to prevent broken bones in older adults.

    Osteoporosis is a key reason why a fall can be so catastrophic for an older person. A bone breaks and with the decreased mobility, a downward spiral begins. Hip fractures for example carry about a 25% risk of mortality within a year.

    Who do bisphosphonates benefit?

    Bisphosphonates are proven to benefit women with very low bone mineral density and women with a history of fractures. Their greatest impact has been on vertebral fractures, although they also have been shown to decrease rates of hip and wrist fractures. To get an idea of the size of the benefit, for every 100 women taking the medicines, six avoided a fracture of some sort over three years of therapy.

    Formulations of the bisphosphates exist where the drugs can be taken weekly or monthly, and these are as effective as the ones taken daily. People who take them should continue to take calcium and vitamin D.

    Good evidence also exists that the bisphosphonates help with the osteoporosis induced by the use of steroids, which sometimes have to be used for years for the treatment of various chronic inflammatory condition.

    Are bisphosphonates overmarketed?

    Some authorities believe that drug companies have overmarketed bisphosphonates, and that doctors prescribe  them to too many women who do not have osteoporosis, but “osteopenia,” a condition invented by the pharmaceutical companies. People with osteopenia have a lower bone mineral density than “normal” but not as low as to be diagnosed with osteoporosis. Our bone densities, muscle mass, brain mass, etc, decline with age.

    For the ravages of aging, the one best thing anyone can do (perhaps besides not smoking) is to exercise. As millions of women took bisphosphonates, reports multiplied of a rare fracture of the femur, after a patient has been on the drug for five years or so, and also of a rare type of deterioration of bone in the jaw. The latter tended to occur in people with cancer or otherwise suppressed immune systems. (You can read more on Just Care here.)

    The evidence is evolving on how long people should take these drugs. After a few years, you should discuss with your doctor whether you should continue, and make sure you understand the risks and continued potential benefits.

    Don’t forget calcium and vitamin D

    Calcium helps keep your bones strong and healthy. So, it is wise to incorporate foods with calcium, such as milk and yogurt, into your daily diet. If you’re not getting enough calcium, exercise may be your best bet for bone health; as I have explained in another post, the evidence is weak that calcium supplements will benefit you.

    Vitamin D supplements also seem to be over-rated as far as bone health, as supplements do not lower fracture risk for those living in the community. It is good to eat salmon and tuna or milk supplemented with vitamin D. For those living in nursing homes on the other hand, they do lower the risk of fractures from falls.

    Here’s more from Just Care:

  • Has osteoporosis been mistreated?

    Has osteoporosis been mistreated?

    Osteoporosis drugs strengthened the bones of millions of women. But their future may not be so bright. Here’s what we know about their long-term effects.

    Since the mid-90s, when Fosamax (alendronate) was first approved, bisphosphonates have been commonly used to effectively treat osteoporosis in millions of patients. 

    But bisphosphonates (the class of drugs that work to rebuild and strengthen bone tissue), which are taken either orally or as injections, are not without side effects and recently, some of the potential long-term effects of these medications, while rare, have come under scrutiny. Conversations about what those effects might or might not be and who, in fact, should be taking these drugs have been taking place in the media and medical community alike.

    One issue is that no one really knows yet the optimum length of time patients should be taking these drugs. A study by the FDA, published in the New England Journal of Medicine, caused a stir — taking on the question of whether or not continued use of bisphosphonates helps patients or might put them at increased risk for atypical fractures or other side effects.

    ‘In other therapies we are confident in saying the effects of the medicine are gone, once we stop giving them… Whereas with bone the exact opposite is true.’ — Kurt Kennel, MD

    The study suggests that taking bisphosphonates beyond 5 years doesn’t necessarily continue to improve bone density or strength for all patients. One recommendation is that patients who were initially at low-risk for osteoporosis-related fractures would probably benefit from discontinuing the medication after 3 to 5 years, whereas those patients at a greater risk from the outset would benefit from continuing.

    To read the rest of this article from the Medshadow Foundation, click here.

    To learn about the latest findings on proton-pump inhibitors, click here.  And, here are five ways to avoid heartburn without drugs.

    If you have Medicare, here are six ways to save money on your drugs.

  • Preventive care: Bone density tests and osteoporosis

    Preventive care: Bone density tests and osteoporosis

    Preventive care is recommended to ensure you stay healthy. Bone density tests or bone mass measurements are a type of preventive care doctors often recommend to diagnose osteoporosis. Patients with osteoporosis have brittle bones and a high likelihood of breaking their bones.

    According to the CDC, 16 percent of women over 50 and 4 percent of men over 50 have osteoporosis of the femur, neck or lumbar spine. The percentage grows significantly for people over 65—24.8 percent of women and 5.6 percent of men.

    Medicare covers the full costs of a bone density test every two years if the doctor prescribes it because:

    1. You are estrogen-deficient at risk for osteoporosis based on medical history or other evidence;
    2. An X-ray shows vertebral abnormalities;
    3. You have been getting steroid treatments for at least three months;
    4. You are diagnosed with hyperparathyroidism;
    5. You are on a drug for osteoporosis.

    For full Medicare coverage, you must see a doctor who takes assignment—accepts Medicare’s rate in full if you have traditional Medicare or an in-network provider if you are in a Medicare Advantage plan. However, if you take the test at the same time as you are getting examined for a range of issues, you will still bear the deductible and coinsurance costs of your doctor’s exam if they are applicable.

    Medicare covers follow-up bone mass measurement or more frequent screenings for osteoporosis if your doctor prescribes them.

    Provided you meet the qualifying criteria, Medicare also covers a range of other preventive care services, including an annual wellness visit, the flu shot, weight counseling, nutrition counseling, smoking cessation, a cardiovascular screening and a diabetes screening.