Thursday, December 20, 2007

FDA Alert: Early communication of bisphosphonate safety

FDA Alert: Early communication of bisphosphonate safety
An article and an accompanying letter to the editor in the May 3, 2007, issue of The New England Journal of Medicine describe increased rates of serious atrial fibrillation in two different studies of older women with osteoporosis treated with the bisphosphonates, Reclast and Fosamax. In both studies, more women who received one of the bisphosphonates (Reclast-1.3% or Fosamax-1.5%) reportedly developed serious atrial fibrillation as compared to women who received placebo (Reclast study-0.5%, Fosamax study-1.0%). In both studies, the rates of all atrial fibrillation (serious plus nonserious) were not significantly different between groups treated with bisphosphonate versus placebo. The FDA reviewed spontaneous post-marketing reports of atrial fibrillation reported in association with oral and intravenous bisphosphonates and did not identify a population of bisphosphonate users at increased risk of atrial fibrillation. In addition, as part of the data review for the recent approval of once-yearly Reclast for the treatment of postmenopausal osteoporosis, the FDA evaluated the possible association between atrial fibrillation and the use of Reclast. Most cases of atrial fibrillation occurred more than a month after drug infusion. Also, in a subset of patients monitored by electrocardiogram up to the 11th day following infusion, there was no significant difference in the prevalence of atrial fibrillation between patients who received Reclast and patients who received placebo. Atrial fibrillation is a heart rhythm disorder common in individuals 65 years old and older, the same age range of many of the patients studied in the article published in The New England Journal of Medicine. Upon initial review, FDA does not believe that healthcare providers should change their prescribing practices of bisphosphonates at this time.

Friday, November 30, 2007

A new study..................

CHICAGO (Reuters) - Bone-weakening osteoporosis may be to blame for more fractures than previously thought, researchers reported on Tuesday.

Bones broken in high-impact automobile crashes or severe falls may have first been weakened by osteoporosis, said a team led by Dawn Mackey of the San Francisco Coordinating Center.

Previously it had been assumed that such fractures occurred simply because of the trauma involved.

As a result, those injuries have not been included among the estimated 1.5 million low-impact osteoporosis-related fractures that occur every year in the United States, the team wrote in a report published in the Journal of the American Medical Association.

Nor have those who suffered such fractures been told they might be prone to breaks generally and should be evaluated for osteoporosis.

The condition, caused by mineral loss that weakens bone, occurs more often and earlier in women. Calcium, vitamin D, exercise and drug treatments can help counter the weakness.

Low-impact fractures linked to osteoporosis are those where bones break in falls from a standing height or less.

They looked at studies involving more than 14,000 U.S. men and women aged 65 and up and found bone mineral density was "strongly associated with high-trauma nonspine fractures in older women and men."

It also found such breaks "predicted subsequent fractures to the same extent as low-trauma nonspine fractures in women."

In a commentary in the same journal, Dr. Sundeep Khosla of the Mayo Clinic in Rochester, Minnesota, wrote, "Fractures previously defined as due to high trauma ... can no longer be dismissed as being unrelated to osteoporosis."

"Older patients who sustain such fractures should be considered for bone mineral density testing and, if clinically indicated, further evaluation for osteoporosis," Khosla added.

In a second related study in the same issue, doctors at the University of California at Davis School of Medicine in Sacramento said they had developed a formula to help predict which post-menopausal women are most at risk for a broken hip.

Age, health, weight, height, race or ethnicity, physical activity, fracture history after 54, parental hip fracture, smoking, corticosteroid use and diabetes are all influences.

The findings came from data collected from thousands of women who participated in a study called the Women's Health Initiative.

(Reporting by Michael Conlon; Editing by Maggie Fox)

A new study..................

CHICAGO (Reuters) - Bone-weakening osteoporosis may be to blame for more fractures than previously thought, researchers reported on Tuesday.

Bones broken in high-impact automobile crashes or severe falls may have first been weakened by osteoporosis, said a team led by Dawn Mackey of the San Francisco Coordinating Center.

Previously it had been assumed that such fractures occurred simply because of the trauma involved.

As a result, those injuries have not been included among the estimated 1.5 million low-impact osteoporosis-related fractures that occur every year in the United States, the team wrote in a report published in the Journal of the American Medical Association.

Nor have those who suffered such fractures been told they might be prone to breaks generally and should be evaluated for osteoporosis.

The condition, caused by mineral loss that weakens bone, occurs more often and earlier in women. Calcium, vitamin D, exercise and drug treatments can help counter the weakness.

Low-impact fractures linked to osteoporosis are those where bones break in falls from a standing height or less.

They looked at studies involving more than 14,000 U.S. men and women aged 65 and up and found bone mineral density was "strongly associated with high-trauma nonspine fractures in older women and men."

It also found such breaks "predicted subsequent fractures to the same extent as low-trauma nonspine fractures in women."

In a commentary in the same journal, Dr. Sundeep Khosla of the Mayo Clinic in Rochester, Minnesota, wrote, "Fractures previously defined as due to high trauma ... can no longer be dismissed as being unrelated to osteoporosis."

"Older patients who sustain such fractures should be considered for bone mineral density testing and, if clinically indicated, further evaluation for osteoporosis," Khosla added.

In a second related study in the same issue, doctors at the University of California at Davis School of Medicine in Sacramento said they had developed a formula to help predict which post-menopausal women are most at risk for a broken hip.

Age, health, weight, height, race or ethnicity, physical activity, fracture history after 54, parental hip fracture, smoking, corticosteroid use and diabetes are all influences.

The findings came from data collected from thousands of women who participated in a study called the Women's Health Initiative.

(Reporting by Michael Conlon; Editing by Maggie Fox)

Thursday, October 04, 2007

An excellent resource on the web....

Check out www.melioguide.com

MelioGuide is the guide for anyone interested in bone health. You will find the latest information on medical intervention, nutrition, and exercise related to building stronger bones. You’ll find tips on how to avoid falls and reduce the risk of a fracture. And you’ll receive an individualized exercise program developed specifically for bone health.

Friday, September 14, 2007

Vitamin D supplements could prolong your life

MONDAY, Sept. 10 (HealthDay News) -- Vitamin D supplements could prolong your life, a new European study suggests.

"The intake of usual doses of vitamin D seems to decrease mortality from any cause of death," said lead researcher Dr. Philippe Autier, from the International Agency for Research on Cancer in Lyon, France.

The new finding, published in the Sept. 10 issue of the Archives of Internal Medicine, is a bit of an anomaly, because the benefits of vitamin supplements remains uncertain at best. While they are often touted as a means of reducing risks for cancer and heart disease, some studies have found supplements have no effect on these conditions.

For example, other studies have shown that vitamin E has no effect on cancer, Autier said. And prior research suggests that multivitamin supplements do nothing to reduce cancer risk, he added.

But vitamin D may be the exception, according to the results of this new study.

"This is the first study that shows that taking one vitamin has an impact on mortality," Autier said. "If you want to increase your vitamin D intake by taking supplements, it looks like a great idea."

In the study, Autier, and his colleague Sara Gandini, from the European Institute of Oncology in Milan, Italy, looked at data from 18 trials involving more than 57,000 people. Doses of vitamin D in the trials varied from 300 to 2,000 international units (IUs), with an average dose of 528 IUs.

Over a follow-up of almost 6 years, 4,777 of the people in the studies died.

Those who took vitamin D supplements had a 7 percent lower risk of death compared with those who didn't take the supplement, Autier and Gandini found.

Nine of the trials had collected blood samples. Those subjects who took the supplements had a 1.4- to 5.2-fold higher level of vitamin D in their blood compared to those who did not, the researchers note.

This finding could lead to new drugs to fight cancer and other diseases, Autier said. "Vitamin D can reduce the proliferation of cells; the proliferation of cells is something you see in cancer," he said.

Autier believes people should take vitamin D supplements in the range of between 400 and 600 IUs daily. "There is no need to take more -- that's crazy," he said. "You have to be careful not to take a dose that's too high," he added.

And there's another way to make sure you get vitamin D, which is important to the uptake of calcium needed for healthy bones. That's to get a moderate amount of sun exposure each day, since the skin uses sunlight to produce its own vitamin D.

Monday, September 10, 2007

BoneSense Guide to Stronger Bones exercises osteoporosis prevention

BoneSense Guide to Stronger Bones exercises osteoporosis prevention

Most Americans Unaware of Dietary Links to Bone Health, Survey Reveals

(NewsTarget) The majority of people in the United States are poorly informed about the prevalence of osteoporosis, according to a study conducted by Opinion Research Corporation for nutritional supplement manufacturer GTC Nutrition.

Opinion Research Corporation questioned 1,031 people by telephone. Eighty-six percent of those questioned believed that women are at greater risk from breast, ovarian or uterine cancer than from bone fractures linked to osteoporosis. According to GTC, however, a woman's risk of osteoporosis-related fracture exceeds her risk of all three types of cancer combined.

Osteoporosis is a disease characterized by low bone mineral density, leading to an increased risk of fractures. Because calcium is essential for the formation of healthy bones, calcium deficiency is one of the primary risk factors for osteoporosis. Other risk factors include hormone excesses or deficiencies, vitamin D deficiency, low activity levels and smoking.

More than two-thirds of survey respondents were also unaware that 90 percent of girls between the ages of 12 and 19 are calcium deficient.

"These survey findings, while concerning, underscore the opportunity Americans have to increase their overall health and well-being by learning more about bone health and the factors that influence it, including calcium absorption," said Coni Francis, senior manager of science, marketing and technical services for GTC. According to a GTC press release, only 30 percent of dietary calcium is absorbed.

Consumer health advocate Mike Adams, author for Truth Publishing, agreed that beyond calcium intake, the absorption of the mineral is an important and often overlooked factor in bone health.

"Worse yet, almost no consumers and very few doctors are aware of the vitamin D link to calcium absorption," Adams said. "Without adequate vitamin D in the body, calcium cannot be absorbed in sufficient quantities, and most Americans, Canadians and Europeans are chronically deficient in vitamin D."

The body synthesizes vitamin D naturally from exposure to sunlight.

Wednesday, September 05, 2007

FDA OKs Once-Yearly Osteoporosis Drug

Reclast Given By IV; First Drug in Class to Be Given Once a Year

Aug. 17, 2007 The FDA today approved Reclast, the first once-yearly drug for postmenopausal osteoporosis, according to the manufacturer Novartis.

The drug was previously approved by the FDA in April for Paget's disease, which can result in misshapen bones in one or more areas of the body. This is the first indication for the drug for osteoporosis, a disorder that causes bones to break easily.

Reclast is given by infusion. Its active ingredient, zoledronic acid, is also marketed by Novartis under the brand name Zometa for use in certain cancer patients.

The drug belongs to a class of medications called bisphosphonates, which also includes the osteoporosis drugs Fosamax, which needs to be taken once a week, and Boniva, which needs to be taken once a month. Both are in pill form.

Reclast is given as a once-yearly 15-minute intravenous (IV) infusion.

The Research on Reclast

A recent study in The New England Journal of Medicine involving more than 7,700 women showed that Reclast reduced spine fractures by 70% and hip fractures by 41%, compared with placebo. The reduction in spine fractures was sustained over three years.

According to the manufacturer, Reclast increases bone strength and reduces fractures in areas of the body typically affected by osteoporosis, including the hip, spine and other areas such as the wrist, arm, leg, or rib.

"Osteoporosis is a serious disease affecting millions of people in this country," says Leo Schargorodski, executive director of the National Osteoporosis Foundation (NOF), in a Novartis news release. "NOF welcomes new FDA approved treatment options, such as Reclast, that give patients a choice when it comes to taking their osteoporosis therapy."

Reclast is not intended for patients with hypocalcemia (low blood calcium) and those who are allergic to zoledronic acid. Patients already being treated with Zometa should not be treated with Reclast.

Reclast should also not be used during pregnancy because of potential harm to the fetus. And Reclast is not recommended for use in patients with severe kidney impairment.

The most common side effects associated with Reclast are fever; pain in the muscles, bones, or joints; flu-like symptoms; and headache. These symptoms usually occur within the first three days following Reclast administration and usually resolve within three to four days of onset, but resolution could take up to seven to 14 days.

Some patients have reported severe bone, joint, and/or muscle pain after using bisphosphonates. Osteonecrosis of the jaw (damage to the bone) has been reported rarely in postmenopausal osteoporosis patients treated with bisphosphonates. A routine oral examination should be performed by the doctor prior to initiation of treatment, according to the manufacturer.

SOURCE: News release, Novartis Pharma AG.

Tuesday, August 07, 2007

Some interesting news about calcitonin

I saw this recent article about calcitonin and its use in osteoarthritis. I hope you find it useful.

A new study shows treatment with calcitonin, a hormone, effectively prevented erosion of knee cartilage in rat models of osteoarthritis. Osteoarthritis is also known as degenerative joint disease and is related to cartilage breakdown in the joints which can lead to joint damage.

Calcitonin is currently used to treat Paget’s disease of the bone and osteoporosis, as previous studies have shown that the hormone reduces bone loss. But researchers say these results suggest that calcitonin may also help prevent the joint destruction associated with osteoarthritis (OA).

Osteoarthritis is the most common joint disorder and affects more than 10% of Americans. Treatment usually addresses easing the pain caused by joint stiffness and inflammation associated with osteoarthritis.

To date, no drug has been approved to prevent the gradual loss of cartilage caused by the disease. But a new understanding of the progression of the disease in recent years has prompted a surge of interest in developing disease-modifying osteoarthritis drugs aimed at potentially preventing the disease in those at risk, such as postmenopausal women.

In the study, published in Arthritis & Rheumatism, researchers compared the effects of treating female rats that had their ovaries removed with estrogen alone and estrogen plus calcitonin.

Loss of estrogen from age or other causes increases the risk of osteoporosis. Other research has suggested that hormone replacement therapy helps protect postmenopausal women from osteoarthritis. This study showed that estrogen therapy and calcitonin given to rats helped reduce the rise in compounds indicative of joint destruction of osteoarthritis.

Calcitonin and estrogen also worked effectively in protecting against surface erosions of joint cartilage.

“Calcitonin treatment may counter the acceleration of cartilage degradation and the related rise of surface erosions,” writes researcher Bodil-Cecilie Sondergaard, of Nordic Bioscience Diagnostics in Herlev, Denmark, and colleagues.

Researchers say these results are only preliminary, but they suggest that calcitonin merits further research in human clinical trials.

ONJ news....

The American Society for Bone & Mineral Research(ASBMR)has recently released its review document on osteonecrosis of the jaw. The link to the full article can be found here http://www.jbmronline.org/doi/abs/10.1359/jbmr.0707ONJ