Osteoporosis

Health Concerns Herbalist

Bone Builders or Bone Hardeners
By Andrew Gaeddert 

Recently, more information has been published concerning the safety and lack of efficacy of bisphosphonate drugs used in the treatment of osteopenia and osteoporosis. Currently, the FDA approved drugs include Fosamax® (alendronate), Actonel® (risedronate), Didronel® (etidronate), Boniva® (ibandronate) and Reclast® (Zometa®). While osteoporosis drugs increase bone mineral density (BMD) and reduce certain fractures in the short-term, trials lasting up to ten years are beginning to raise doubts about the long-term safety and efficacy of bisphosphonates.1, 2 The main issue is that these drugs inhibit osteoclastic bone resorption and inhibit osteoblastic bone formation, and block normal bone mineralization. Case reports3 have shown that fracture healing slows considerably due to Fosamax.

Studies from Singapore and the Hospital for Special Surgery in New York have documented a total of 87 men and women who had atypical fractures associated with Fosamax and other bisphosphonates. Most patients had been taking bisphosphonates for four to seven years before the event. Fractures were associated with low impact events such as tripping, and many patients could feel the bone snap prior to falling. Patients show specific and unusual fracture patterns than are visible on X-rays.4 Even though bisphosphonates increase BMD, they still may make bones more likely to fracture in the low-term. Although bone appears to be stronger, the ability to endure bending pressure without breaking is reduced. In an editorial to the Journal of Endocrinology and Metabolism, Dr. Susan Ott of the University of Washington suggests that bone tissue in Fosamax treated women resembles a form of “adynamic bone disease”.5

Dr. Ott urges caution in the long-term use of bisphosphonates, as the research shows efficacy only for the first five years. Other reasons to be cautious about the long-term use of bisphosphonates include damage to the mouth, esophagus, and stomach. Taking too little water with Fosamax, can expose the esophageal or gastric lining which can cause heartburn and ulcers. Special care must be practiced to take these drugs correctly. Taking Fosamax with food or other medications significantly reduces the drug’s absorption. Most doctors who prescribe osteoporosis drugs do not tell their patients about the potential risks including sever bone pain, gastrointestinal disease, Osteonecrosis of the jaw, and arterial fibrillation.6, 7, 8, 9, 10

Clinical evidence suggests that BioStrong can help bone health in a number of ways. This mineral treatment has been shown to reduce fracture risk and increase bone density in human trials with thousands of patients. BioStrong can be combined with calcium, vitamin D, and the empirical herbal formula OsteoHerbal, a formula comprised of fifteen traditional Chinese herbs used to heal and prevent bone fractures.

References

  1. Hosking D, Chilvers CE, Christiansen C, et al. Prevention of bone loss with alendronate in postmenopausal women under 60 years of age. Early Postmenopausal intervention Cohort Study Group. N Engl J Med. 1998;338:485-492
  2. Rosen CJ. Clinical practice. Postmenopausal osteoporosis. N Engl J Med. 2005;353:595-603.
  3. The researchers had grants from the US Public Health Service and the University of Texas Southwest Medical Center, Dallas.
  4. Neviaser AS, lane JM, Lenart BA, Edobor-OsulaF, Lorich DG. Low-energy femoral shaft fractures associated with alendronate use. J Orthop Trauma. 2008;22:346-350.
  5. Bone HG, Hosking D, Devogelaer JP, et al. Ten years experience with alendronate for osteoporosis in postmenopausal women. N Engl J Med. 2004;350:1189-1199.
  6. Wysowski DK. Reports of esophageal cancer with oral bisphosphonate use. N Engl J Med. 2009;360:89-90.
  7. Chustecka Z. Esophageal cancer in patients taking oral bisphosphonates [Web page]. Medscape Medical News. 2008. http:// www.medscape.com/viewarticle/586127.
  8. Heckbert SR, Li G, Cummings SR, Smith NL, Psaty BM. Use of alendronate and risk of incident atrial fibrillation in women. Arch Intern Med. 2008;168:826-831.
  9. Miranda J. Osteoporosis drugs increase risk of heart problems. Presented at: CHEST 2008: the 74th annual assembly of the American College of Chest Physicians; October 25-30, 2008; Philadelphia, PA.
  10. 15 FDA Alert 1/7/2008. “Information on Bisphosphonates.” http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm 101551.htm. Accessed on 7/10/09.

Do Osteoporosis Drugs Cause Fractures?
By Andrew Gaeddert

Prolonged use of Fosamax, also referred to by the generic name bisphosphonate alendronate, may increase the risk of fractures of the femur, the large thigh bone that connects the leg to the hip, according to physicians at the Weill Medical College of Cornell University. Case studies have revealed that long term Fosamax usage may overly suppress bone metabolism, increasing the risk of fractures. “Many of these women will tell you they thought the bone broke before they hit the ground,” said Dr.Dean G. Lorich, associate director of orthopedic trauma surgery at New York-Presbyterian/Weill Cornell and the Hospital for Special Surgery. Dr. Lorich and his colleagues published a study in The Journal of Orthopaedic Trauma last month reporting on 20 patients with the fracture. Nineteen had been using the bone drug Fosamax for an average of 6.9 years. Last year, The Journal of Bone and Joint Surgery published a Singapore report of 13 women with low-trauma fractures, including 9 who had been on long-term Fosamax therapy.1

In January 2006, the Medical Journal Geriatrics published an unusual autobiographical case report. Dr. Jennifer Schneider, a 59-year-old physician from Tucson, wrote that she was riding a New York City subway when the train lurched. “I felt a crack and I fell,” she recalled in an interview. “I knew I’d fractured my femur.” Dr. Schneider, who had been taking Fosamax for seven years, said she had had pain in her thigh, but X-rays and scans had not found a problem. In recent years, another rare side effect has been associated with bone drugs: osteonecrosis of the jaw, in which a patient’s jawbone rots and dies. Most victims are cancer patients taking a potent intravenous form of the drug, but a small number of cases from ordinary users have been reported.

Notably, studies suggest there is little extra benefit in taking the bone drugs more than five years. Dr. Lorich says that doctors should monitor the bone metabolism of long-term users and that some patients may want to consider taking time off the drugs. When fractures do occur, surgeons need to be alerted about long-term drug use, because the fracture may require more aggressive treatment and be slower to heal.1

BioStrong™ contains a mineral which increases bone density and reduces fracture risk. In a study of 1649 postmenopausal women who had at least one vertebral fracture, participants taking this mineral treatment had half as many vertebral fractures at the end of a year as the control group who received placebos. After three years, bone density increased 14.4 percent in the spine, and 8.3 percent at the femoral neck. In the largest study, 5,091 women who took therapeutic dosages every day for three years showed a 41 percent reduction in hip fractures.2

Notes

  1. http://www.nytimes.com/2008/07/15/health/15well.html?_r=1&scp=1&sq=9%20who%20had%20been%20on%20longterm%20Fosamax%2 herapy&st=cse&oref=slogin
  2. Gaeddert, Andrew, Health Concerns Clinical Handbook, Professional Health Concerns, Oakland CA, 2007, p.68.

An interview with Andrew Gaeddert, author of five books. His latest title is, Healing Digestive Disorders, 4th edition.

Recently you reported that in some circumstances bisphosphonate drugs may actually increase fracture risk?

The main treatments for osteoporosis are nutrition and exercise. Herbs have been traditionally used to improve balance, reduce fractures, and to speed the healing of bones. For people with severe osteoporosis, drugs can be helpful, but come with many side effects. While many drugs have been shown to increase bone density their records are not impressive in terms of actually preventing fractures.   

What’s new in osteoporosis treatment?

The biggest breakthroughs in my opinion are the importance of Vitamin D in addition to adequate calcium intake, and BioStrong, a nutritional supplement that contains a form of naturally occurring strontium which has improved absorption over other mineral forms. 

I understand there is a new strontium drug? 

Yes, in Europe a form of strontium is used to support bone health and reduce fracture risk. It is available in a powder form. Unfortunately, it also contains aspartame, which may negatively affect bone health. BioStrong is free of aspartame and contains and equivalent dose in two capsules per day. 

Are there additional clinically effective solutions?

My mentor, Dr. Fung Fung, developed an herbal formula OsteoHerbal based upon his over sixty years experience using Chinese herbs. OsteoHerbal contains kidney tonics, and other ingredients that are traditionally used to improve strength, and balance, as well as speed the healing of fractures. We have heard reports from clinicians that this formula improves bone density and balance.

Can BioStrong and OsteoHerbal be combined? Can they be taken with other treatments?

Yes. BioStrong and OsteoHerbal can be taken at the same time between meals, while we generally recommend most supplements such as calcium and Vitamin D be taken with meals. We also suggest that OsteoHerbal and BioStrong be taken apart from Western pharmaceuticals.


For more information read Andrew Gaeddert’s newsletters— Beyond Calcium: Nutrients for Osteoporosis, BioStrong: A New Formula for Osteoporosis, and Commonly Asked Practitioner Questions: BioStrong, Leantain and Polilipid.

Nutritional Solution for Joint Pain
By Andrew Gaeddert 

In osteoarthritis, also known as degenerative joint disease, there are microscopic changes in the structure and composition of cartilage responsible for joint discomfort. Cartilage may swell because of water retention, become soft, and then develop cracks. Tiny cavities form in the bone beneath the cartilage weakening the bone. Eventually the cartilage becomes rough and pitted so that the joint can no longer move smoothly and absorb impact.

Symptoms usually develop gradually and affect only one or a few joints at first. Joints of the fingers, base of the thumbs, neck, lower back, big toes; hips and knees are commonly affected. In some people, the joint may be stiff after sleep or inactivity. In time, the joint may become less flexible and the joints may grind, grate, and crackle when they are moved. As osteoarthritis progresses the joint lining and sites where the ligaments and tendons attach to the bone may become inflamed.

Inflammation may also occur in connective tissue diseases including rheumatoid arthritis (RA), psoriatic arthritis, Reiter’s Syndrome (reactive arthritis), and ankylosing spondylitis. In these conditions, there is also joint pain and swelling. In RA, components of the immune system attack the soft tissue that lines and can attack connective tissue in many parts of the body. Eventually the cartilage, bone, and ligaments of the joint erode, causing deformity, instability and scarring within the joint. Psoriatic arthritis resembles RA, causing inflammation of the joints hips and spine. When inflammation is chronic, the joints may become swollen and deformed. Reiter’s syndrome is inflammation of the joints and tendon attachments of the joint, often accompanied by inflammation of the eye, mouth, and genitourinary tract. Ankylosing spondylitis is the inflammation of the spine and large joints resulting in stiffness and pain.

Why is nutrition an important solution for people with painful, stiff, and aching joints? It can be tempting to reach for aspirin and other NSAID pills or Tylenol. However, aspirin and NSAIDs can cause bleeding and increase the risk of heart attack, whereas too much Tylenol is associated with liver problems. Natural products such as Glucosamine often take three months to work, and TCM treatments involve high dosages of herbs. The Solution: Collagenex 2 (NEM®).

Collagenex 2 features the same ingredients found in human joints and connective tissue including naturally occurring glycosaminoglycans, including glucosamine, chondroitin, hyaluronic acid, collagen, and other proteins. Collagenex 2 (NEM) is derived from eggshell membrane and processed with an advanced manufacturing process. In clinical studies, the active ingredient has been shown to reduce joint discomfort by 25 percent in just seven days at the dosage equivalent to one capsule of Collagenex 2 per day.

The results of the studies showed that supplementation with Collagenex 2 (NEM) produced an average 25% reduction in pain (both Study 1 & Study 2) in just 7 days. By the end of the 30-day trial, patients in Study 1 had an average reduction in pain of more than 72% (see graph) and nearly half of these patients reported that they were completely pain-free by the end of the study. Patients in Study 2 experienced more moderate relief with an average of 30% reduction in pain at the completion of the trial, however about one-third of them experienced more than 50% reduction in pain. No side effects were reported by study participants in either trial.

Risk of Osteoporosis Drugs 

A widely prescribed class of drugs for osteoporosis has been shown to prevent common hip and spine fractures associated with the bone wasting disease, but there are concerns that the drugs might cause a different set of problems. The recommendation could affect many of the estimated four million women in the United States who take the drugs called bisphosphonates. Bisphosphonates inhibit the bone renewal process called resorption, adding bone mass, but possibly causing brittleness as well.

The F.D.A. announced that it would convene a joint meeting of advisory committees on drug safety and reproductive health to reconsider osteoporosis drugs after evidence surfaced linking long-term use with unusual breaks of the femur or thighbone, bone death in the jaw, and possibly esophageal cancer.

Bisphosphonates include Fosamax, Boniva, Actonel, and Atelvia and growing numbers of generics. There are many questions. One is whether the drugs have been proved to be safe and effective for longer term use, while the other is whether to restrict that use or require “drug holidays”. Most research on the drugs is for three to five years, but many women take them indefinitely.

Last October, the F.D.A. ordered the makers of bisphosphonate drugs to add a warning to their labels about a small increased risk of atypical femur fractures. In 2005, it added a warning about the rare jaw disease called osteonecrosis. Because the risks may increase with the length of time the drug is taken, whether to impose a stronger warning or even a ban on long-term use is the chief issue facing the advisory panels and the government. There is not a consensus among experts, leaving some clinicians and women uncertain about what is best in individual cases.

Dr. Susan M. Ott, an associate medical professor and bone specialist at the University of Washington, who takes no research funds from industry, summarized the current science in a 12-page review article published by the Cleveland Clinic Journal of Medicine on Thursday. “In my opinion, after five years in most cases it ought to be stopped,” Dr. Ott said in an interview. She prescribes the drugs for shorter periods, but said evidence shows growing risks and no proven benefits after five years.

“The longest anybody could have taken this drug is 15 years now,” Dr. Ott said. “It’s an ongoing experiment, and there are a few million women in the country who are participating in it. I keep wanting to say, ‘You’re all guinea pigs after five years because that’s when the studies stopped.’ ” 1

Merck is facing about 1,115 lawsuits over jaw damage and 535 over unusual femur fractures and other bone injuries, the company said last month in a quarterly report. Although it is good that the FDA is doing a safety review after sixteen years, there are nutritional and herbal strategies that offer many benefits over pharmaceuticals. It is believed that nutrients such as Vitamin D, calcium, magnesium, and NuLignan (7-hydroxymatairesinol) may produce healthier bones over time and certainly have fewer adverse reports. The bone-building mineral BioStrong has been shown in clinical studies to improve bone density and reduce fracture risk.2 Whereas, the empirical formula OsteoHerbal is traditionally used to improve bone health and balance. OsteoHerbal contains Chinese herbs traditionally used to strengthen the sinews and bones, and nourish blood.

  1. Duff Wilson. F.D.A. to Review Safety of Popular Bone Drugs. http://www.nytimes.com/2011/09/06/health/06bone.html, Accessed on 9/8/11.
  2. Andrew Gaeddert. Health Concerns Clinical Handbook.2011.P70

Osteoporosis: Not for women only
By Andrew Gaeddert

Although women have a higher prevalence of osteoporosis, men get osteoporosis for many of the same reasons according to the National Osteoporosis Foundation (NOF.org).

Two million American men have osteoporosis and another twelve million are at risk. Many of the risk factors for men are the same as for women: the prolonged usage of medications such as steroids, immunosuppressives, anticoagulants, and cytotoxic agents. Hormonal treatments such as Gonadotropin Releasing Hormone (GnRH), used in the treatment of prostate cancer are also known to increase the risk of osteoporosis and fractures. It is estimated that more than 500,000 men are put on GnRH agonists each year. Additional risk factors include chronic disease affecting the kidneys, lungs, stomach and intestines, low calcium intake, lack of exercise, smoking and excessive alcohol intake.

BioStrong contains a proven mineral used to increase bone density. It has shown to be as effective as the current drugs on the market. OsteoHerbal is an empirical herbal formula that includes kidney-supporting herbs that are thought to benefit bone mineral density. These formulas are best used over a period of several years, and should be taken with adequate Calcium and Vitamin D. 

Osteoporosis Drugs Prevent Fractures, but Patients Worry about Side Effects
By Andrew Gaeddert 

Osteoporosis remains a serious health problem for the 10 million Americans who have it and the 34 million who are at risk due to low bone mass; 80% of sufferers are women. It is estimated that one-half of women and one-quarter of men over age 50 will suffer an osteoporosis-related fracture.

A diet rich in calcium, plenty of exposure to vitamin D and weight-bearing exercise all help to build strong bones. Too little of those can weaken them, as can smoking, drinking alcohol, and a taking a variety of medications, including corticosteroids, anticonvulsants and antidepressants. Excessive dieting, exercising, and being very thin—with a body-mass index of less than 20—can also leave your bones with little reserve. Being obese actually lowers your risk, though it can overstress your joints. But some people can do everything right and still develop osteoporosis if they have a strong genetic predisposition.

A bone-mineral-density test can give you one indication of how strong your bones are. You and your doctor can also assess your risk by using an online tool developed by the World Health Organization called FRAX, for Fracture Assessment Risk Tool (www.shef.ac.uk/FRAX). It asks your sex, age, weight, height, hip-bone density and factors such as smoking, drinking, and parental hip fractures. It computes your chances of suffering a major bone fracture in the next 10 years.

The National Osteoporosis Foundation’s latest guidelines say that women who have a 3% risk of developing a hip fracture or 20% risk of other major fracture in the next 10 years are candidates for treatment, on cost-effectiveness grounds. In studies of older women with osteoporosis, Fosamax has been found to reduce the chance of hip and spine fractures as much as 50%. But it’s less clear to what extent such drugs can prevent osteopenia from becoming osteoporosis. Experts say that individual patients should never be treated based on T-scores or FRAX probabilities alone. Many other considerations apply. 

For health professionals it is always important to consider the unique characteristics of your patients. A fifty-year-old woman with osteopenia may not be a candidate for pharmaceutical drugs based on bone density alone. However, if her mother suffered osteoporosis or had fractures, treatment may be indicated.

The official guidelines also do not take into account potential side effects of the bisphosphonates. Gastrointestinal upsets are the most common; the oral medications are not recommended for patients who cannot sit upright for at least a half-hour because these drugs can irritate the esophagus. Gastro-esophageal reflux disease (GERD) can make such discomfort worse. Some patients have also reported severe bone and muscle pain, and osteonecrosis of the jaw (ONJ) while taking bisphosphonates.1          

Other osteoporosis drugs on the market work differently and carry different risks. Evista (raloxifene) acts on estrogen receptors and can cut the risk of breast cancer as well as spinal fractures in some women, although it does not prevent hip fractures. Forteo (teriparatide) is a daily injection for women with severe osteoporosis, but has been linked with bone malignancies in rats. In 2009, an advisory panel recommended that the FDA approve denosumab, a biological agent that blocks the production of osteoclasts that break down bone. It would be a twice-yearly injection.2            

Estrogen-replacement therapy can also help women postpone the rapid loss of bone mass that occurs after menopause. It is no longer recommended for bone protection alone—in part because of the added risk of heart disease and breast cancer found in older women in the Women’s Health Initiative studies. The long-term safety of estrogen is not known.

Some clinics urge women to fight osteoporosis with lifestyle changes rather than pharmaceuticals. At our affiliated clinics, we recommend 1200mg a day of calcium from food or supplements, and 1,000IU of vitamin D per day. BioStrong, a mineral treatment has been shown to reduce fracture risk and increase bone density in human trials with thousands of patients, and OsteoHerbal, an empirical herb formula used to heal and prevent bone fractures. All clients are encouraged to perform at least 30 minutes of weight bearing exercise three times per week.

Endnotes

  1. Wall Street Journal – wsj.com
  2. Wall Street Journal – wsj.com

Practitioner Findings

BioStrong contains a mineral proven to increase bone density and reduce fracture risk. It is useful for clients who have osteoporosis and osteopenia. This is important because over ten million Americans have osteoporosis; a 50-year-old woman has a 50 percent chance of having an osteoporosis fracture in her lifetime. Men are also at risk of osteoporosis.

Research suggests that BioStrong is as effective as osteoporosis medications, with fewer side effects, at just two capsules per day. As calcium and vitamin D compete with the absorption, they should be taken two hours or more, apart from BioStrong. Results are seen in two to three years. Here is what practitioners are saying:

Two years ago, I accompanied my 86-year-old mother to a routine doctor’s visit and listened to the results of her dexa scan and the doctor’s insistence that she start on Fosamax immediately!! I respectfully disagreed with the doc and explained to her that I had a product in my herbal pharmacy that I wanted my mother to try instead of Fosamax, Boniva, etc. Two weeks ago my mother had a dexa scan after being on BioStrong for 2 years and the results were so fantastic that when we walked into the doc’s office this morning, she was thrilled and practically dancing in her seat as she reviewed the results! Three areas were specifically flagged on the report as having “significant change” and all were statistically relevant!!

Risk of Fractures due to Poor Bone Health
By Andrew Gaeddert 

Recently the Surgeon General announced that half of all Americans over fifty years of age will be at risk for fractures from osteoporosis and poor bone health. Ten million Americans over fifty have osteoporosis, another 34 million are at risk of developing the condition and 1.5 million have suffered a bone fracture related to osteoporosis. Chief among the suggestions for good bone health are to maintain healthy weight, take the recommended daily amounts of calcium and vitamin D and to exercise regularly. 

As the evidence is far from conclusive that botanicals such as soy and red clover actually build bone density, I have been searching for an effective natural remedy, and I have found it. It is called BioStrong.  Bio Strong consists of Strontium carbonate a mineral and Bioperine a patented herbal extract that increases nutrient absorption. One of the benefits of BioStrong is the convenient dosage of just 2 capsules per day.  Studies have shown each ingredient is pure, safe and effective. Health Concerns also has available an herbal formula, OsteoHerbal, based on the wisdom of Dr. Fung Fung, one of the most experienced herbalists in world. It is designed to reduce fractures and improve bone density. One may incorporate both formulas can be incorporated into other bone building nutrient programs.

Studies suggest that by taking BioStrong with adequate calcium and vitamin D, it may be possible to increase bone density within the first year, and reduce fractures up to 44 percent after two years. It is recommended that patients take both BioStrong and OsteoHerbal between meals and take calcium supplements with meals. BioStrong is 100 percent vegetarian.  Therefore, vegetarian clients who do not wish to take OsteoHerbal can benefit from BioStrong.  BioStrong can be taken by itself between meals.

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