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Osteoporosis Drugs (Fosamax, Actonel, Boniva)

These drugs were designed to help slow bone loss and complications due to osteoporosis. Just last year, over 36 million people took these drugs across America, including people here in New England. Recently, a great deal of research shows that these drugs actually INCREASE the risk of severe fractures in the jaw and leg (femur).

A recent study by the New England Journal of Medicine showed a SUBSTANTIAL INCREASE in femur fractures associated with the use of Fosamax, Actonel, and Boniva type medicines (bisphasphonates). These studies also revealed that the longer patients took these drugs the higher the changes they would be harmed by them. Another study by the Journal of the American Medical Association found that the long-term use of Fosamax, Actonel, and Boniva (or other bisphasphonates) increased the rare risk of fumur fractures by THREE TIMES vs. use by women who used these drugs for less than 100 days.

Although these side-effects are not typical, these drugs are still being prescribed in huge numbers.

SHEFF LAW FOSAMAX OVERVIEW

Osteonecrosis or “dead jaw” has been linked to patients using both injectable and oral bisphosphonates such as Fosamax, a review from FDA’s Office of Drug Safety states.

Reports indicate that the connection between bisphosphonates such as Fosamax, and Osteonecrosis of the jaw (ONJ) was discovered as early as 2004. The findings were published in the Journal of Oral and Maxillofacial Surgeons and showed the side effects of Fosamax may include ONJ, a condition commonly called “dead jaw.”

Osteonecrosis of the jaw is a disease in which bone tissue in the jaw does not heal after minor traumas. Dental extractions that cause bone to become exposed can lead to fractures and infections often requiring long-term antibiotic therapy and surgery to remove the dead and dying bone tissue. Some researchers and pharmaceutical experts state that prevention and early treatment of patient using Fosamax is critical in the preservation of a healthy jaw bone. Individuals using Fosamax and other bisphosphonates should try to avoid tooth extractions and other major dental work while taking these medications. Symptoms of “dead jaw” include irregular sore with exposed bone, pain or swelling in the infected jaw, infection, possibly with pus, altered sensation - numbness or a heavy sensation.

The highest risk factors for ONJ are:

taking bisphosphonates like Fosamax, especially in IV form
concurrent use of steroids
previous history of cancer, osteoporosis or Paget's disease
traumatic dental procedure, such as tooth extraction or dental implants.

Osteoporosis

Consider an insidious condition that drains away bone--the hardest, most durable substance in the body. It happens slowly, over years, so that often neither doctor nor patient is aware of weakening bones until one snaps unexpectedly. Unfortunately, this isn't science fiction. It's why osteoporosis is called the silent thief.

And it steals more than bone. It's the primary cause of hip fracture, which can lead to permanent disability, loss of independence, and sometimes even death. Collapsing spinal vertebrae can produce stooped posture and a "dowager's hump." Lives collapse too. The chronic pain and anxiety that accompany a frail frame make people curtail meaningful activities because, in extreme cases, the simplest things can cause broken bones: Stepping off a curb. A sneeze. Bending to pick up something, a hug. "Don't touch Mom, she might break" is the sad joke in many families.

Osteoporosis leads to 1.5 million fractures, or breaks, per year, mostly in the hip, spine and wrist, with the cost of treatment estimated at $17 billion and rising, according to the National Institutes of Health (NIH). It threatens 34 million Americans, mostly older women, but older men get it too. One in 2 women and 1 in 4 men older than 50 will suffer a vertebral fracture, according to the NIH. These numbers are predicted to rise as the population ages.

Osteoporosis, which means "porous bones," is a condition of excessive skeletal fragility resulting in bones that break easily. A combination of genetic, dietary, hormonal, age-related, and lifestyle factors all contribute to this condition. The osteoporosis seen in postmenopausal women is the most common and best-studied, but there are other causes that may be treated differently.

Changing attitudes and improving technology are brightening the outlook for people with osteoporosis. Nowadays, many women live 30 years or more--perhaps a quarter to a third of their lives--after menopause. Improving the quality of those years has become an important health care goal. Although some bone loss is expected as people age, osteoporosis is no longer viewed as an inevitable consequence of aging. Diagnosis and treatment need no longer wait until bones break.

There is no cure or proven preventive treatment for osteoporosis, but the onset can be delayed and the severity diminished. Most important, early intervention can prevent devastating fractures. The Food and Drug Administration has revised labeling on foods and supplements to provide valuable information about the level of nutrients that help build and maintain strong bones. The FDA has also approved a wide variety of products to help diagnose and treat osteoporosis, including several in the last few years.

Osteoporosis has been described as a geriatric disease with an adolescent onset, highlighting the importance of beginning to take steps--in exercise and diet--early in life to reduce its disabling impact in later years.

Bone Life

Bone consists of a matrix of fibers of the tough protein collagen, hardened with calcium, phosphorus and other minerals. Two types of architecture give bones strength. Surrounding every bone is a tough, dense rind of cortical bone. Inside is spongy-looking trabecular bone. Its interconnecting structure provides much of the strength of healthy bone, but it is especially vulnerable to osteoporosis.

"We tend to think of the skeleton as an inert erector set that holds us up and doesn't do much else. That's not true," says Karl L. Insogna, M.D., director of the Bone Center at Yale School of Medicine in New Haven, Conn. Every bit as dynamic as other tissues, bone responds to the pull of muscles and gravity, repairs itself, and constantly renews itself.

Besides protecting internal organs and allowing us to move about, bone is also involved in the body's handling of minerals. Of the 2 to 4 pounds of calcium in the body, nearly 99 percent is in the teeth and skeleton. The remainder plays a critical role in blood clotting, nerve transmission, muscle contraction (including heartbeat), and other functions. The body keeps the blood level of calcium within a narrow range. When needed, bones release calcium.

A complex interplay of many hormones balances the activity of the two types of cells--osteoclasts and osteoblasts--responsible for the continuous turnover process called remodeling. Osteoclasts break down bone, and osteoblasts build it. In youth, bone building prevails. Bone mass peaks by about age 30, then bone breakdown outpaces formation, and density declines, since the volume of bone remains about the same.

The skeleton is like a retirement account for minerals, but in our skeletal "account" we can deposit bone faster than we withdraw it only during our first three decades. After that, withdrawals are greater than deposits, and all we can do is try to minimize the net loss. Osteoporotic fractures are the sign of the bankruptcy that occurs when too little bone is formed during youth, or too much is lost later, or both.

"You've got to get as much bone as you can and not lose it," Insogna says. "The most important risk factor for osteoporosis is a low bone mass." "The upper limit of bone mass that you can acquire is genetically determined," says Mona S. Calvo, Ph.D., a calcium expert in the FDA's Center for Food Safety and Applied Nutrition. "But even though you may be programmed for high bone mass, other factors can influence how much bone you end up with," she says. For instance, men tend to build greater bone mass, which is partly why more women face osteoporosis.

But there's another reason. With the decline of the female hormone estrogen at menopause, usually around age 50, bone breakdown markedly increases. For several years, women lose bone two to four times faster than they did before menopause. The rate usually slows down again, but some women may continue to lose bone rapidly. By age 65, some women have lost half their skeletal mass.

Diagnosis

Because the changes at menopause increase a woman's risk, many physicians feel it's a good time to measure a woman's bone mineral density, especially if she has other risk factors for osteoporosis."The best way to gauge a woman's risk for osteoporotic fracture is to measure her bone mass," says Insogna. Routine X-rays can't detect osteoporosis until it's quite advanced, but other radiological methods can. The FDA has approved several kinds of devices that use various methods to estimate bone density. Most require far less radiation than a chest X-ray. Doctors consider a patient's medical history and risk factors in deciding who should have a bone density test. The method used is often determined by the equipment available locally. Readings are compared to an internationally accepted standard based on young Caucasian women. Different parts of the skeleton may be measured, and low density at any site is worrisome.

Bone density tests are useful for confirming a diagnosis of osteoporosis if a person has already had a suspicious fracture, or for detecting low bone density so that preventive steps can be taken.

"There's a profound relationship between bone mass and risk of fracture," says Robert Recker, M.D., director of the Osteoporosis Research Center atCreighton University in Omaha, Neb.

Readings repeated at intervals of a year or more can determine the rate of bone loss and help monitor treatment effectiveness. However, estimates are not necessarily comparable between machine types because they use different measurement methods, cautions Joseph Arnaudo, in the FDA's Center for Devices and Radiological Health. "You always want to go back to the same machine, if you can," he says.

A newer technique for evaluating bone strength is ultrasound, and the FDA has approved several instruments for this purpose. "These machines use the same principles that are employed when using ultrasound to look at fetuses during pregnancy," says Leo Lutwak, M.D., Ph.D., of the FDA's Division of Reproductive, Abdominal, and Radiological Devices. "Although this measurement examines different properties of bone than do X-ray-based bone densitometers, the results are also useful for prediction of fracture." The devices for ultrasound measurement are cheaper and easier to use. This makes them available in more locations and allows evaluation for osteoporosis in many more subjects. "Because they don't use X-rays, they are safer and may be used for repeated examinations, even in pregnant women and children, so they provide a means for better public health practice," Lutwak says.

Another new test provides an indicator of bone breakdown. In 1995, the FDA approved a simple, noninvasive biochemical test that detects in a urine sample a specific component of bone breakdown; called NTx. Clinical labs can get results in about 2 hours. The NTx test, marketed as Osteomark, can help physicians monitor treatment and identify fast losers of bone for more aggressive treatment, but the test doesn't measure bone metabolism specifically, so it may not be used to diagnose osteoporosis.

Expanding Treatment Options

Physicians and patients now have more treatment options. Under FDA guidelines, drugs to treat osteoporosis must be shown to preserve or increase bone mass and maintain bone quality in order to reduce the risk of fractures.

An important treatment option became available to women in November 2002. Forteo (teriparatide) is the first treatment that stimulates new bone growth to increase bone mass. Forteo is a portion of human parathyroid hormone, which works in the body to regulate the metabolism of calcium and phosphate in bones. The treatment is given in daily injections and is approved for postmenopausal women who are at high risk for bone fractures.

The approval of this treatment comes with a strong caution from the FDA: In the pre-approval studies of Forteo using rats, there was an increase in the incidence of osteosarcoma, a rare but serious cancer of the bone. Because it's possible that women treated with Forteo could have increased risk for developing this cancer, doctors are advised to discuss this risk with their patients and be sure that it's the best treatment. Women who are prescribed Forteo receive an FDA-approved medication guide that explains the benefits and risks and gives other advice about how to use the treatment properly.

All other drugs approved for osteoporosis treatment act by slowing the turnover of bone, rather than stimulating new bone formation. Increases in bone mass are most pronounced in the first year or two after treatment with the drugs begins, then taper off. Any gain is helpful, even if it doesn't continue, because increases in bone mass help reduce fracture risk.

In the mid-1990s, the FDA approved the first nonhormonal treatment for osteoporosis. Alendronate, marketed as Fosamax, falls within a class of drugs called bisphosphonates. In clinical trials, Fosamax increased the bone mass as much as 8 percent and reduced fractures as much as 30 percent to 40 percent, depending on skeletal site.

To avoid damage to the esophagus, Fosamax should be taken according to the instructions. These instructions include taking the drug in the morning upon awaking and at least half an hour before eating. The drug should be taken with a glass of water, and the person should remain upright for half an hour after taking it. Fosamax should not be taken by people who cannot stand or sit upright or who have disorders that prevent esophageal emptying into the stomach. Other drugs recently approved for the prevention and treatment of osteoporosis are Actonel (risedronate), a bisphosphonate similar to Fosamax, and Evista (raloxifene), a drug in a class known as selective estrogen receptor modulators, or SERMs. Both drugs have been shown to reduce the risk for fracture of the spine.

Calcitonin is a hormone that plays a role in calcium and bone metabolism. When used regularly, it can slow the loss of bone. Available for many years as an injection, calcitonin treatment became much easier when FDA approved a nasal spray.

Fluoride, known for fighting dental cavities, stimulates bone building, but studies in osteoporosis patients have found that the structure of the new bone was abnormal and weaker than normal bone.

While estrogen may be a good option for some women, new guidelines developed in 2003 by the FDA advise doctors to consider alternative treatments. These changes were prompted by studies indicating that women who take estrogen or estrogen with progestin products after menopause are at higher risk for other conditions, including cardiovascular disease and breast cancer. Because of this, estrogen-containing products should only be considered for women at significant risk of osteoporosis.

Drugs Not Enough

Calcium and vitamin D supplements are an integral part of all treatments for osteoporosis. At the same time, people who take supplements should keep in mind that it is possible to consume excess amounts of these and other nutrients. Attention to diet and exercise is important not only for treatment, but also for prevention.

"If you go to the doctor and get a prescription, and that's all you do, you're probably not going to be helped very much," Recker says.

Calcium intake is critical, and those who need it most--younger women and girls--may not get enough. But calcium alone can't build bones. Vitamin D is needed to help the body absorb calcium. Most people appear to get enough vitamin D because the skin produces it in sunlight. And many foods, such as milk products and breakfast cereals, are fortified with vitamin D. But older adults and people with little exposure to sunlight may need a vitamin D supplement.

A lifelong habit of weight-bearing exercise, such as walking or biking, also helps build and maintain strong bone. The greatest benefit for older people is that physical fitness reduces the risk of fracture, because better balance, muscle strength, and agility make falls less likely. Exercise also provides many other life-enhancing psychological and cardiovascular benefits. Increased activity can aid nutrition, too, because it boosts appetite, which is often reduced in older people. The biggest reason older people don't get enough calcium, Recker says, is that they simply don't eat much.

"The truth is, you don't have to do very much to get most of the benefits of exercise," Recker says. He suggests 30 minutes of brisk walking five days a week. Add a little weightlifting, and that's even better. It's always smart to ask your doctor before starting a new exercise program, especially if you already have osteoporosis or other health problems.

Brighter Horizons

The search for bone-building drugs continues. Some naturally occurring bone-specific growth factors have been identified and their use as drugs is being investigated. "The way I visualize the ideal future is that we'll be able to give Drug X that builds up bone to where it's stronger and the risk of fracture is no longer present, then Drug Y maintains it by preventing breakdown," says Paula Stern, Ph.D., a pharmacologist at Northwestern University MedicalSchool in Chicago.

The study of risk factors also continues. "We consider that to be the research that has the greatest public health significance," says Sherry Sherman, Ph.D., of the National Institute on Aging.

For More Information
National Osteoporosis Foundation
1232 22nd St., N.W., Washington, DC 20037
(800) 223-9994

Osteoporosis and Related Bone Diseases National Resource Center (ORBD-NRC)
2 AMS Circle, Bethesda, MD 20892
(800) 624-BONE (624-2663); TTY: (202) 466-4315

Older Women's League (OWL)
1750 New York Ave., Washington, DC 20001
(800) 825-3695

North American Menopause Society
P.O. Box 94527, Cleveland, OH 44101
(800) 774-5342

Source
FDA Office of Public Affairs
If you suffer from dead jaw, Osteonecrosis or bone death as a result of taking Fosamax you should contact an attorney. Please fill out the form below and your submission will be forwarded to an experienced attorney.

OSTEOPOROSIS FAST FACTS

Definition
Osteoporosis, or porous bone, is a disease characterized by low bone mass and structural deterioration of bone tissue, leading to bone fragility and an increased susceptibility to fractures, especially of the hip, spine and wrist, although any bone can be affected.

Prevalence
Osteoporosis is a major public health threat for an estimated 44 million Americans, or 55 percent of the people 50 years of age and older. In the U.S., 10 million individuals are estimated to already have the disease and almost 34 million more are estimated to have low bone mass, placing them at increased risk for osteoporosis.

Of the 10 million Americans estimated to have osteoporosis, eight million are women and two million are men. Significant risk has been reported in people of all ethnic backgrounds. While osteoporosis is often thought of as an older person's disease, it can strike at any age.

Osteoporosis in Women
Eighty percent of those affected by osteoporosis are women. Twenty percent of non-Hispanic white and Asian women aged 50 and older are estimated to have osteoporosis, and 52 percent are estimated to have low bone mass.

Five percent of non-Hispanic black women over age 50 are estimated to have osteoporosis; an estimated additional 35 percent have low bone mass that puts them at risk of developing osteoporosis. Ten percent of Hispanic women aged 50 and older are estimated to have osteoporosis, and 49 percent are estimated to have low bone mass.

Osteoporosis is under-recognized and under-treated not only in Caucasian women, but in African-American women as well.

One in two women and one in four men over age 50 will have an osteoporosis-related fracture in her/his remaining lifetime. Osteoporosis is responsible for more than 1.5 million fractures annually, including:

over 300,000 hip fractures; and approximately 700,000 vertebral fractures;
250,000 wrist fractures; and 300,000 fractures at other sites. Hip fracture risk is increasing most rapidly among Hispanic women. Women with a hip fracture are at a four-fold greater risk of a second one, and the risk factors are similar to those for the first hip fracture. Osteoporotic fractures lower a patient’s quality of life. The most typical sites of fractures related to osteoporosis are the hip, spine, wrist and ribs, although the disease can affect any bone in the body. The rate of hip fractures is two to three times higher in women than men; however, the one year mortality following a hip fracture is nearly twice as high for men as for women.

A woman's risk of hip fracture is equal to her combined risk of breast, uterine and ovarian cancer.

In 2001, about 315,000 Americans age 45 and over were admitted to hospitals with hip fractures. Osteoporosis was the underlying cause of most of these injuries.

An average of 24 percent of hip fracture patients aged 50 and over die in the year following their fracture. One in five of those who were ambulatory before their hip fracture requires long-term care afterward. At six months after a hip fracture, only 15 percent of hip fracture patients can walk across a room unaided. Not just hip fractures, but vertebral fractures are also linked with an increased risk of death. One in five hip fracture patients ends up in a nursing home, a situation that participants in one study described as less desirable than death.

White women aged 65 or older have twice the incidence of fractures as African-American women.

Osteoporosis in Men
Twenty percent of those affected by osteoporosis are men. Seven percent of non-Hispanic white and Asian men aged 50 and older are estimated to have osteoporosis, and 35 percent are estimated to have low bone mass.

Four percent of non-Hispanic black men aged 50 and older are estimated to have osteoporosis, and 19 percent are estimated to have low bone mass. Three percent of Hispanic men aged 50 and older are estimated to have osteoporosis, and 23 percent are estimated to have low bone mass.

Cost
The estimated national direct expenditures (hospitals and nursing homes) for osteoporotic hip fractures was $18 billion dollars in 2002, and the cost is rising.

Symptoms
Osteoporosis is often called a "silent disease" because bone loss occurs without symptoms. People may not know that they have osteoporosis until their bones become so weak that a sudden strain, bump or fall causes a fracture or a vertebra to collapse. Collapsed vertebrae may initially be felt or seen in the form of severe back pain, loss of height, or spinal deformities such as kyphosis or stooped posture.

Risk Factors
Certain people are more likely to develop osteoporosis than others. Factors that increase the likelihood of developing osteoporosis and fractures are called "risk factors." These risk factors include:

Personal history of fracture after age 50
Current low bone mass
History of fracture in a 1° relative
Being female
Being thin and/or having a small frame
Advanced age
A family history of osteoporosis
Estrogen deficiency as a result of menopause, especially early or surgically induced
Abnormal absence of menstrual periods (amenorrhea)
Anorexia nervosa
Low lifetime calcium intake
Vitamin D deficiency
Use of certain medications (corticosteroids, chemotherapy, anticonvulsants and others)
Presence of certain chronic medical conditions
Low testosterone levels in men
An inactive lifestyle
Current cigarette smoking
Excessive use of alcohol
Being Caucasian or Asian, although African Americans and Hispanic Americans are at significant risk as well
Women can lose up to 20 percent of their bone mass in the five to seven years following menopause, making them more susceptible to osteoporosis.

Detection
Specialized tests called bone mineral density (BMD) tests can measure bone density in various sites of the body. A BMD test can:

Detect osteoporosis before a fracture occurs
Predict chances of fracturing in the future
Determine rate of bone loss and/or monitor the effects of treatment if a DXA BMD test is conducted at intervals of one year or more

Medicare reimburses for BMD testing every two years. An increase in BMD testing and osteoporosis treatment was associated with a decrease in hip fracture incidence.Bone density is an important determinant of fracture risk even in nursing home patients. There has been a five-fold increase in office visits for osteoporosis (from 1.3 to 6.3 million) in the past 10 years.

Prevention
By about age 20, the average woman has acquired 98 percent of her skeletal mass. Building strong bones during childhood and adolescence can be the best defense against developing osteoporosis later. There are five steps, which together can optimize bone health and help prevent osteoporosis.

They are:

A balanced diet rich in calcium and vitamin D
Weight-bearing and resistance-training exercises
A healthy lifestyle with no smoking or excessive alcohol intake
Talking to one’s healthcare professional about bone health
Bone density testing and medication when appropriate
A study of disease management in a rural healthcare population demonstrated that a preventive program was able to reduce hip fractures and save money.

Medication
Although there is no cure for osteoporosis, the following medications are approved by the FDA for postmenopausal women to prevent and/or treat osteoporosis:

Bisphosphonates:

Alendronate and alendronate plus vitamin D (brand name Fosamax® and
Fosamax® plus D)
Ibandronate (brand name Boniva®)
Risedronate and risedronate with calcium (brand name Actonel® and Actonel® with Calcium)
Calcitonin (brand name Miacalcin®)

Estrogen/Hormone Therapy:

Estrogens (brand names, such as Climara®, Estrace®, Estraderm®, Estratab®, Ogen®, Ortho-Est®, Premarin®, Vivelle® and others)
Estrogens and Progestins (brand names, such as Activella™, FemHrt®, Premphase®, Prempro® and others)
Parathyroid Hormone – Teriparatide (PTH (1-34) (brand name Fortéo®)

Selective Estrogen Receptor Modulators (SERMs):

Raloxifene (brand name Evista®)

Alendronate is approved as a treatment for osteoporosis in men and is approved for treatment of glucocorticoid (steroid)-induced osteoporosis in men and women. Risedronate is approved for prevention and treatment of glucocorticoid-induced osteoporosis in men and women. Parathyroid hormone is approved for the treatment of osteoporosis in men who are at high risk of fracture.

Treatments under investigation include sodium fluoride, vitamin D metabolites, and other bisphosphonates and selective estrogen receptor modulators

Medical experts agree that osteoporosis is highly preventable. However, if the toll of osteoporosis is to be reduced, the commitment to osteoporosis research must be significantly increased. It is reasonable to project that with increased research, the future for definitive treatment and prevention of osteoporosis is very bright.

Fosamax and Osteonecrosis of the Jaw
The use of Fosamax to treat osteoporosis has been linked to osteonecrosis of the jaw (ONJ), disease in which bone tissue in the jaw does not heal after minor traumas. Dental extractions that cause bone to become exposed can lead to fractures and infections often requiring long-term antibiotic therapy and surgery to remove the dead and dying bone tissue. Some researchers and pharmaceutical experts state that prevention and early treatment of patient using Fosamax is critical in the preservation of a healthy jaw bone. Individuals using Fosamax and other bisphosphonates should try to avoid tooth extractions and other major dental work while taking these medications.

Symptoms of “dead jaw” include irregular sore with exposed bone, pain or swelling in the infected jaw, infection, possibly with pus, altered sensation - numbness or a heavy sensation.