JAMA news releases are made available to the public after 3 pm US Central time on the first 4 Tuesdays of each month. The Archives Journals news releases are made available to the public after 3 pm Central time on Mondays. We also provide a list of previous news releases.
THIS WEEK'S CONTENT
JAMA NEWS RELEASES
(Embargoed for Release: 3:00 p.m. CT, Tuesday, December 26, 2006)
JAMA NEWS RELEASES
WOMEN MAY BE ABLE TO ‘TAKE BREAK’ FROM OSTEOPOROSIS DRUG WITHOUT LOSING BENEFIT
INCIDENCE OF STROKE DECREASES OVER LAST 50 YEARS
ACID SUPPRESSION MEDICATION LINKED WITH INCREASED RISK OF HIP FRACTURE
JAMA REPORT (VIDEO SCRIPT)
VIDEO: Windows Media | Quicktime
ALENDRONATE SO EFFECTIVE IN IMPROVING BONE STRENGTH, MAY KEEP WORKING AFTER WOMEN QUIT TAKING IT
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Embargoed for Release: 3:00 p.m. CT, Tuesday, December 26, 2006
Media Advisory: To contact Dennis M. Black, Ph.D., call Nancy Chan at 415-476-2557. To contact editorialist Cathleen S. Colon-Emeric, M.D., M.H.Sc., call Richard Merritt at 919-660-1309.
WOMEN MAY BE ABLE TO ‘TAKE BREAK’ FROM OSTEOPOROSIS DRUG WITHOUT LOSING BENEFIT
CHICAGO—Most postmenopausal women who took the osteoporosis drug alendronate for 5 years and then stopped did not have an increased risk for nonvertebral fractures in the next 5 years, suggesting the medication has a lasting effect, according to a study in the December 27 issue of JAMA.
Osteoporosis is common among postmenopausal women. The disease is characterized by increased bone turnover (when aging bone is broken down faster than it can be replaced), progressive loss of bone mass and increased fracture risk. Bisphosphonates are the most commonly used medications for postmenopausal osteoporosis, according to background information in the article. Alendronate, a potent bisphosphonate, decreases bone turnover, increases bone mineral density (BMD), and decreases vertebral, nonspine, and hip fracture risk in women with osteoporosis. Treatment for osteoporosis often continues indefinitely, but few studies have examined the effects of using bisphosphonates longer than 5 years or the effects of stopping treatment after 5 years. Some studies have suggested that stopping treatment after several years might result in continued effectiveness because of a residual effect of the drug, but the magnitude and duration of this remains uncertain.
The Fracture Intervention Trial (FIT), a randomized, blinded, placebo-controlled trial, examined the effect of daily alendronate on BMD and fracture risk in postmenopausal women with low BMD. Average follow-up during treatment was 3.8 years, with optional open-label treatment continuation after trial completion. In this article, Dennis M. Black, Ph.D., of the University of California, San Francisco, and colleagues report data from the FIT Long-term Extension (FLEX), which was designed to evaluate the effects on BMD of either continuation of alendronate, 5 or 10 mg/d for a total of 10 years, or discontinuation after approximately 5 years. The trial was conducted at 10 clinical centers, and 1,099 postmenopausal women were randomized to: alendronate, 5 mg/d (n = 329) or 10 mg/d (n = 333), or placebo (n = 437) for 5 years (1998-2003).
The researchers found that compared with continuing alendronate, switching to placebo for 5 years resulted in declines in BMD at the total hip (-2.4 percent) and spine (-3.7 percent), but average levels remained at or above pretreatment levels 10 years earlier. Similarly, those discontinuing alendronate had increased serum markers of bone turnover compared with continuing alendronate, but after 5 years without therapy, bone marker levels remained somewhat below pretreatment levels 10 years earlier. After 5 years, the cumulative risk of nonvertebral fractures was not significantly different between those continuing (19 percent) and discontinuing (18.9 percent) alendronate. Among those who continued, there was a 55 percent lower risk of clinically recognized vertebral fractures.
“...the BMD and bone marker changes suggest some residual effect from 5 years of alendronate treatment that is evident for at least 5 years after discontinuation,” the authors write.
“We conclude that continuation of alendronate (either 5 or 10 mg/d) for 10 years maintains bone mass and reduces bone remodeling [continuous turnover of bone mineral] compared with discontinuation after 5 years. The results confirm the safety of alendronate for up to 10 years including no increased fracture risk with long-term alendronate use. However, even among those who discontinued therapy after 5 years, BMD remained at or above baseline values 10 years earlier and bone turnover was still somewhat reduced. Discontinuation did not increase the risk of nonvertebral fractures or x-ray–detected vertebral fractures over the next 5 years, but the risk of clinically diagnosed vertebral fractures was significantly increased among those who discontinued.
“These results suggest that for many women, discontinuation of alendronate after 5 years for up to 5 more years does not significantly increase fracture risk, but women at high risk of clinical vertebral fractures, such as those with vertebral fracture or very low BMD, may benefit by continuing beyond 5 years,” the researchers write.
(JAMA. 2006;296:2927-2938. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
EDITORIAL: TEN VS. FIVE YEARS OF BISPHOSPHONATE TREATMENT FOR POSTMENOPAUSAL OSTEOPOROSIS — ENOUGH OF A GOOD THING
In an accompanying editorial, Cathleen S. Colon-Emeric, M.D., M.H.Sc., of Duke University Medical Center, Durham, N.C. comments on the findings of the study by Black and colleagues.
“The FLEX trial has several important clinical implications. First, women who have a good response to 5 years of bisphosphonate therapy (3 percent - 5 percent increase in hip BMD, 8 percent - 10 percent increase in spine BMD ...) and are not otherwise at increased risk of vertebral fracture can consider a ‘holiday’ period of up to 5 years without therapy. This strategy would clearly improve the reported cost-effectiveness of bisphosphonates. However, the importance of careful BMD monitoring is increased in such women; those rapidly losing BMD will likely require resumption of bisphosphonate therapy or a switch to an alternative agent.”
“Findings from FIT and similar trials established that starting bisphosphonate therapy in postmenopausal women with osteoporosis or a low-trauma fracture substantially reduces their risk of vertebral and nonvertebral fractures, pain, and disability. Now, armed with FLEX data, physicians may be able to begin telling women when they have had enough of a good thing,” Dr. Colon-Emeric writes.
(JAMA. 2006;296:2968-2969. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Dr. Colon-Emeric reports that she has received research funding and consultancy funding from Novartis Pharmaceuticals.
For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org.
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Embargoed for Release: 3:00 p.m. CT, Tuesday, December 26, 2006
Media Advisory: To contact corresponding author Philip A. Wolf, M.D., call Gina Digravio at 617-638-8491.
INCIDENCE OF STROKE DECREASES OVER LAST 50 YEARS
CHICAGO—The incidence of stroke in the U.S. over the past 50 years has declined, although the severity of stroke has not, according to a study in the December 27 issue of JAMA.
Stroke continues to be a major public health concern, with more than 750,000 new strokes occurring each year in the United States. It is the third leading cause of death behind heart disease and cancer and the leading neurologic cause of long-term disability, according to background information in the article. Prior estimates of long-term trends in the incidence and severity of stroke have varied. Determining trends could help guide health programs, public policy, and the allocation of research funding.
Raphael Carandang, M.D., of Boston University, and colleagues examined data from the Framingham Study (health study, with participants initially recruited in 1948) to determine long-term trends in the incidence, lifetime risk, severity, and 30-day risk of death from clinical stroke. This study included 9,152 Framingham Study original participants and offspring undergoing follow-up for up to 50 years over three consecutive time-periods (1950-1977, 1978-1989, and 1990-2004), with ascertainment of stroke risk factor data every 2 years and active surveillance for occurrence of stroke or death.
The researchers found that the age-adjusted annual incidence of clinical stroke and atherothrombotic brain infarctions (ABI) in participants age 55 to 94 years decreased over the 3 periods. The incidence of clinical stroke decreased significantly. Across the 3 periods, the lifetime risk of clinical stroke (by age 90 years) decreased from 19.5 percent to 14.5 percent in men age 65 years and from 18.0 percent to 16.1 percent in women. Age-adjusted stroke severity did not vary across periods; however, death within 30 days of stroke decreased significantly in men (from 23 percent to 14 percent) but not significantly in women (from 21 percent to 20 percent).
“The severity of stroke has not decreased and 30-day mortality has decreased significantly only in men, perhaps due to an older age at onset of stroke and more severe strokes in women. These sobering trends emphasize that while improved control of risk factors has lowered incidence of stroke, there is a need for greater primary prevention efforts to reduce the lifetime risk, severity, and 30-day mortality following stroke,” the authors conclude.
(JAMA. 2006;296:2939-2946. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: This study was supported by grants from the National Institute of Neurological Disorders and Stroke and the National Heart, Lung, and Blood Institute’s Framingham Heart Study. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org.
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Embargoed for Release: 3:00 p.m. CT, Tuesday, December 26, 2006
Media Advisory: To contact Yu-Xiao Yang, M.D., M.S.C.E., call Olivia Fermano at 215-349-5653.
ACID SUPPRESSION MEDICATION LINKED WITH INCREASED RISK OF HIP FRACTURE
CHICAGO—Use of the drugs proton pump inhibitors (PPIs) for the treatment of acid-related diseases such as gastro esophageal reflux disease (GERD) is associated with a greater risk of hip fracture, according to a study in the December 27 issue of JAMA.
Potent acid suppressive medications such as PPIs have revolutionized the management of acid-related diseases. Millions of individuals have been using these medications on a continuous or long-term basis, according to background information in the article. Some research has shown that PPI therapy may decrease insoluble calcium absorption or bone density in certain patients. These factors could increase the risk for hip fracture, which has a death rate during the first year after the fracture of 20 percent. Among those who survive this period, 1 in 5 require nursing home care and often an emergency department visit, hospitalization, surgery, and rehabilitation, with huge health care costs.
Yu-Xiao Yang, M.D., M.S.C.E., of the University of Pennsylvania School of Medicine, Philadelphia, conducted a study to determine what effects PPI therapy has on bone metabolism and hip fracture risk in a large group representative of the general population. The researchers analyzed data from the General Practice Research Database (1987-2003), which contains information on patients in the United Kingdom. The study group consisted of users of PPI therapy and nonusers of acid suppression drugs who were older than 50 years.
There were 13,556 hip fracture cases and 135,386 controls. The researchers found that more than 1 year of PPI therapy was associated with a 44 percent increased risk of hip fracture. The risk was 2.6 times higher among long-term users of high-dose PPI therapy. The strength of the association with hip fractures increased with both the dosage and the duration of PPI therapy.
“In summary, we observed that PPI therapy is associated with a significantly increased risk of hip fractures, with the highest risk seen among those receiving high-dose PPI therapy. Osteoporotic fractures are common among the elderly population, and they entail considerable morbidity and mortality. On the other hand, PPI therapy is widespread and may have an exaggerated effect among those at risk for osteoporosis. Thus, further studies are urgently needed to confirm our findings and clarify the underlying mechanism.
“At this point, physicians should be aware of this potential association when considering PPI therapy and should use the lowest effective dose for patients with appropriate indications. For elderly patients who require long-term and particularly high-dose PPI therapy, it may be prudent to reemphasize increased calcium intake, preferably from a dairy source, and co-ingestion of a meal when taking insoluble calcium supplements,” the authors write.
(JAMA. 2006;296:2947-2953. Available to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org.
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JAMA REPORTS
VIDEO: Windows Media | Quicktime
ALENDRONATE SO EFFECTIVE IN IMPROVING BONE STRENGTH, MAY KEEP WORKING AFTER WOMEN QUIT TAKING IT
VIDEO:
B-ROLL
Judy taking pill
AUDIO:
FIFTY-EIGHT-YEAR OLD JUDY SHERIDAN STARTED TAKING ALENDRONATE FOR BONE STRENGTH FOUR YEARS AGO, WHEN HER BONE TEST SHOWED HINTS OF OSTEOPOROSIS.
VIDEO:
SOT/FULL
@ :08
Super: Judy Sheridan
Takes alendronate
Runs : 07
AUDIO:
“It is helping me because I’ve had a follow-up test a couple years after I started and my bone strength had improved.”
VIDEO:
B-ROLL
Judy descending flight of stairs
Different woman taking pill
GFX/JAMA Cover
AUDIO:
SHE EVEN SURVIVED A FALL DOWN THE STAIRS WITH ONLY A BRUISE AND NOT A FRACTURE. BUT HOW MANY YEARS IS IT SAFE AND EFFECTIVE TO TAKE ALENDRONATE? A NEW STUDY IN JAMA, THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, ANSWERS THAT QUESTION.
VIDEO:
SOT/FULL
@ :16
Super: Dennis Black, Ph.D.
University of California, San Francisco
Runs : 07
AUDIO:
“The drug was safe to use for as long as ten years. We didn’t see any negative effects of long-term use.”
VIDEO:
B-ROLL
Bone scans on computer screen
Dr. Black and colleague at computer
Another woman taking pill
AUDIO:
BUT THAT’S NOT ALL THE STUDY FOUND. DR. DENNIS BLACK WAS PART OF A NATIONWIDE TEAM OF RESEARCHERS WHO TRACKED ABOUT A THOUSAND ELDERLY WOMEN TAKING ALENDRONATE.
VIDEO:
SOT/FULL
Dennis Black, Ph.D.
University of California, San Francisco
Runs : 13
AUDIO:
“On average, the women in the study had five years of previous alendronate use. They were then randomly assigned to get five more years of alendronate, or five years of placebo, a sugar pill.”
VIDEO:
B-ROLL
Woman having bone test
Different woman having bone test
AUDIO:
AFTER THE SECOND FIVE YEARS, BONE TESTS SHOWED THAT WOMEN WHO GOT PLACEBO DID LOSE A LITTLE BONE COMPARED TO WOMEN TAKING ALENDRONATE. BUT THE BONE FRACTURE RATES WERE ESSENTIALLY THE SAME.
VIDEO:
SOT/FULL
Dennis Black, Ph.D.
University of California, San Francisco
Runs : 11
AUDIO:
“Suggesting that for many women, they may be able to discontinue alendronate after five years and still maintain a five-year additional fracture benefit.”
VIDEO:
B-ROLL
Woman walking with a cane
Other elderly women walking on street
Judy picking up paper, walking out of shot
AUDIO:
WOMEN WHO’VE HAD FRACTURES ALREADY ARE AT HIGH RISK FOR ANOTHER FRACTURE, AND PROBABLY SHOULD NOT STOP TAKING ALENDRONATE. BUT JUDY’S NOT IN THAT GROUP, AND SHE LIKES THE IDEA OF GETTING A MEDICATION’S BENEFIT EVEN AFTER SHE QUITS TAKING IT.
VIDEO:
SOT/FULL
Judy Sheridan
Takes alendronate
Runs : 03
AUDIO:
“I personally would just as soon not take medication if I didn’t have to.”
VIDEO:
B-ROLL
Judy taking pill, different shot
AUDIO:
AND IN ANOTHER YEAR, SHE MAY NOT HAVE TO KEEP TAKING ALENDRONATE. THIS IS MAVIS PRALL WITH THE JAMA REPORT.
