Posted by on March 11, 2010 - 10:23am

The FDA recently issued the following communication report:     Patients and healthcare professionals may have questions about oral bisphosphonate medications and atypical subtrochanteric femur fractures – fractures in the bone just below the hip joint. Oral bisphosphonates are commonly prescribed to prevent or treat osteoporosis in postmenopausal women. Common brand names of medications in this class include Fosamax, Actonel, Boniva, and Reclast.  Recent news reports have raised the question about whether there is an increased risk of this type of fracture in patients with osteoporosis using these medications. At this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures. FDA is working closely with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather additional information that may provide more insight into this issue.

Based on published case reports of atypical subtrochanteric femur fractures occurring in women with osteoporosis using bisphosphonates, FDA, in June 2008, requested information from all bisphosphonate drug manufacturers regarding this potential safety signal. All available case reports and clinical trial data were requested. FDA's review of these data did not show an increase in this risk in women using these medications.
In addition, FDA reviewed a December 2008 article in the Journal of Bone and Mineral Research by Abrahamsen et al1, that analyzed data from two large observational studies in patients with osteoporosis. The authors concluded that atypical subtrochanteric femur fractures had many similar features in common with classical osteoporotic hip fractures, including patient age, gender, and trauma mechanism. The data showed that patients taking bisphosphonates and those not taking bisphosphonates had similar numbers of atypical subtrochanteric femur fractures relative to classical osteoporotic hip fractures.

The FDA will continue to review new information as it becomes available and will update the public once the agency's review is complete.

Healthcare professionals should continue to follow the recommendations in the drug label when prescribing oral bisphosphonates. Patients should not stop taking their medication unless told to do so by their healthcare professional. Patients should talk to their healthcare professional about any concerns they have with these medications.

Additional Information for Patients

If you currently take an oral bisphosphonate you should:

* Not stop taking your medication unless told to do so by your healthcare professional.
* Talk to your healthcare professional if you develop new hip or thigh pain or have any concerns with your medications.
* Report any side effects with your bisphosphonate medication to FDA's MedWatch program.

Additional Information for Healthcare Professionals

FDA recommends that healthcare professionals should:

* Be aware of the possible risk of atypical subtrochanteric femur fractures in patients taking oral bisphosphonates.
* Continue to follow the recommendations in the drug label when prescribing oral bisphosphonates.
* Discuss with patients the known benefits and potential risks with using oral bisphosphonates.
* Report any adverse events with the use of oral bisphosphonates to FDA's MedWatch program.

References:

1. Abrahamsen B., Eiken P., Eastell R. Subtrochanteric and Diaphyseal Femur Fractures in Patients Treated With Alendronate: A Register-Based National Cohort Study. J Bone Miner Res. 2009 Jun;24(6):1095-102.

Posted by on March 5, 2010 - 12:07pm

Throughout my career, I have been a strong proponent of medical research through consumer advocacy and educational activities. But recently, I had the opportunity to actually participate as a research subject!  As an enrollee in the Illinois Women's Health Registry, my health profile matched the criteria that a researcher was seeking for an osteoarthritis (OA) study.  The project is called the MAK-3 Study and its purpose is to explore whether people with stronger hip muscles have a slower rate of OA progression and whether different factors of knee instability are related to knee OA progression.

My camera flash picked up the reflector balls/markers taped to my joints ---  could this be the new look in jewelry!!

My Registry profile included "knee pain" which flagged me as a potential match for this study.  I gave permission for the Registry staff to give my name to the research coordinator for the study and I was selected!  The study is being done at Northwestern University and it involves 2 or 3 visits for a variety of non-invasive evaluation procedures.   They would be done at baseline (this past month) and repeated two years later.   This is what they call an "observational" study.  It will not directly benefit me, but it would help scientists better understand this condition and the factors that influence it.  Since my family was riddled with osteoarthritis, I wanted to participate.

I chose to do the evaluations in three rather than two sessions because it fit my work schedule better.   At the first session, I filled out numerous surveys about pain, my medications and my exercise habits.    A physical therapist watched me walk down the hall several times to observe my "gait".    I was then hooked up to equipment that measured muscle strength ( it looked like much of the equipment you see at your local gym, just with gauges to measure strength). They asked me to perform some typical knee and hip movements like leg lifts and recorded my muscle strength.  After that a physician examined my legs and hips and reviewed my medication history.  I was asked if I would provide an optional urine sample that would be stored to eventually be used to test any new biomarker tests for OA that may be developed.  I was provided a diary where I recorded by physical activity for a week at home.

At the second session I met the team in a research lab that was equipped with sensors along the ceiling and a hollow floor that ran wires to a lot of computerized equipment. They taped small reflective balls to my joints and had me walk up and down the room many times while the sensors picked up the signals from these balls  (see picture!)    When I finished, the researcher showed me what the sensors were detecting.    The computer screen showed a stick figure (me) with multicolored dots on my joints (representing the reflecting balls) moving across the screen.   They were recording my alignment and gait.   It was very interesting to see my stick figure move across the screen.    Once they pulled off the sensor balls, they measured the speed of my normal walk by making me walk down a hallway and timing me.

A few weeks later I went to a different location where I had a special x-ray taken that included, on one film, my ankle, knee and hip joint to see how they lined up.  This was followed by rather long MRIs on each of my knees.   This was the hardest (but tolerable) part of the study, I needed to stay still for 40 minutes per knee.   At least they gave me headphones and my head was outside the MRI machine where I watched a bird trying to get through the window.  Throughout this experience the research coordinator explained what would happen and why it was done.   Since I was going to physical therapy for my knee at the time, it was helpful to have her explain where they saw strengths and weakness in my hips and knees.  It made me appreciate why the PT was having me do certain exercises on these related muscle groups.

Finally, the best part of this experience was knowing that I may actually be contributing to science, with little interruption (total 7- 8 hours) in my life.   They will have me back in two years to repeat these tests and determine the status of my OA symptoms.  By the way, I was given a stipend to cover my expenses like parking---and  just enough  to take a few girlfriends out for a nice lunch and get them to join the Illinois Women's Health Registry!

Posted by on March 4, 2010 - 10:15am

The Illinois Women's Health Registry is currently featured on the Northwestern University homepage.  To read the latest article about the Registry go to http://www.northwestern.edu/newscenter/stories/2010/03/registry.html.  And you if you live in Illinois, sign up for the Registry!

Posted by on March 3, 2010 - 10:28am

Vaginal birth after cesarean (VBAC) is the delivery of a baby through the vagina after a previous cesarean delivery. For most of the 20th century, clinicians believed that once a woman had undergone a cesarean, all of her future pregnancies required delivery by that procedure as well. In the 1980s, vaginal birth after cesarean (VBAC) also began to be considered a viable option for these women. Since 1996, however, VBAC rates in the United States have consistently declined, while cesarean delivery rates have been steadily rising. What accounts for these changing practice patterns? An improved understanding of the clinical risks and benefits of both procedures, and how these risks interact with legal, ethical, and economic forces to shape provider and patient choices about VBAC, may have important implications for health services planning and informed decisionmaking.

An impartial, independent, Consensus Development Conference panel will hold a press telebriefing to discuss their findings and implications for the public following the NIH Consensus Development Conference on Vaginal Birth After Cesarean (VBAC): New Insights, March 8-10, 2010. The panel’s statement will incorporate their assessment of the available evidence from a systematic literature review, expert presentations, and audience input to inform patient and provider decisions regarding VBAC.

This blog site will post a summary once the guidelines are released.

Posted by on March 2, 2010 - 2:18pm

What is Endometriosis?

Endometriosis is a disorder in which the endometrial tissue, or the inner lining of the uterus, migrates to areas outside the uterus, most commonly the ovaries and Fallopian tubes.  The endometrial tissue is the same tissue that thickens throughout the menstrual cycle and sheds (bleeds) causing the menstrual period.  When this process occurs outside the uterus, the blood has nowhere to go causing pain in the pelvic region and sometimes cysts or adhesions.

The symptoms of endometriosis include pelvic pain, heavy menstrual periods, bleeding between periods and infertility.  Because many other conditions can cause these symptoms, endometriosis is often difficult to diagnose.  The causes of endometriosis are uncertain, but it does tend to run in families, and having children likely reduces the risk of endometriosis.  Treatment for endometriosis ranges from symptom management with pain medication and hormone therapy such as oral contraceptives to surgical treatment.  Conservative surgery involves removing the misplaced endometrial tissue while preserving the uterus.  In severe cases and in cases where women are not hoping to reproduce in the future, a hysterectomy may be performed.  Endometriosis is not the same as endometrial cancer, which is cancer of the uterine lining, although the two conditions do share many similar symptoms, often allowing for early detection of endometrial cancer.

Resources at Northwestern for Treatment of Endometriosis:

The Prentice Women’s Hospital at Northwestern Memorial Hospital provides comprehensive gynecologic services from some of the best Chicago gynecologic clinicians.  The hospital provides gynecological services that span a woman’s lifetime from well woman care, routine examinations and screenings to contraceptive management, menopause-related care, and incontinence and bladder care.

To request a first-time appointment, call 1-877-926-4664 or go online at http://ww2.nmh.org/contact/request_appointment/new_patient

Research at Northwestern in Endometriosis:

The Department of Obstetrics and Gynecology at the Feinberg School of Medicine is comprised of eleven different divisions pertaining to women’s obstetric and gynecological health.  The department has several full-time research faculty whose research projects focus on an array of disorders including endometriosis, gynecological cancers, HIV, and maternal-fetal health.  With over 50 current research projects and 4 active clinical trials, the department is a dynamic leader in women’s gynecological research.

For more information on clinical trials through the Department of OB/Gyn, see their website at http://www.feinberg.northwestern.edu/obgyn/research/clinical-trials/

IWHR Highlighted Researcher:

Serdar E. Bulun, MD is the Director of the Division of Reproductive Biology Research and Professor in the Department of Obstetrics and Gynecology at Northwestern’s Feinberg School of Medicine.   Dr. Bulun’s translational research interests are focused on estrogen biosynthesis and metabolism in diseases such as breast cancer, uterine fibroids, and endometriosis.  Specifically Dr. Bulun has studied aromatase expression in these hormone-related diseases and is responsible for the introduction of aromatase inhibitors as a treatment for endometriosis.  His translational research in endometriosis and fibroids has made a significant contribution both to the body of research in obstetric and gynecological disorders and to the health of millions of women suffering from these conditions.  Since his seminal paper in 1996, more than 300 articles have been published in the area of aromatase and endometriosis; this exceptional achievement earned him a NIH-MERIT award in 2010.  His current focus in endometriosis research is on retinoid production and action.  Dr. Bulun is a member of the American Society for Clinical Investigation, the American Gynecological and Obstetrical Society, and the Society for Gynecologic Investigation and has served on the editorial boards of several prestigious journals including the Endocrine Reviews and is the U.S. Editor for the Journal of Molecular Endocrinology.

Posted by on February 26, 2010 - 5:13pm

According to a study that was coordinated by investigators at Northwestern University's Feinberg School of Medicine, two to three times more pregnant women may soon be diagnosed and treated for gestational diabetes, based on new measurements for determining risky blood sugar levels for the mother and her unborn baby.

“As result of this study, more than 16 percent of the entire population of pregnant women qualified as having gestational diabetes,” said lead author Boyd Metzger, MD.  “Before, between 5 to 8 percent of pregnant women were diagnosed with this.”

Blood sugar levels that were once considered in the normal range are now seen as causing a sharp increase in the occurrence of overweight babies with high insulin levels, early deliveries, cesarean section deliveries and potentially life-threatening preeclampsia, a condition in which the mother has high blood pressure that affects her and the baby. Large babies, the result of fat accumulation, are defined as weighing in the upper 10 percent of babies in a particular ethnic group. Because large babies increase the risk of injury during vaginal delivery, many of the women in the study were more likely to have a cesarean section.  To view entire news report written by science writer, Marla Paul click here.

Posted by on February 17, 2010 - 2:22pm

On February 15, 2010 the NIH issued a news release about a new analysis reported in the Annals of Internal Medicine on data from the Women's Health Initiative (WHI).  The study reevaluated whether or not combination hormone therapy (estrogen+progestin) increases the risk of heart disease in healthy postmenopausal women. Researchers from the National Heart, Lung, and Blood Institute (NHLBI) and the Harvard School of Public Health reanalyzed data from the WHI, comparing the effects of hormone therapy (HT) on heart disease risk among women who began hormone therapy within 10 years of menopause to women who began therapy more that 10 years after menopause. Recently, there has been a lot of debate among clinicians and researchers whether or not the time between the start of menopause and the initiation of hormone treatment affects the cardiovascular risk.  Some believed that the risk may not be present in women who start HT shortly after they go into menopause.  In this new study,  the researchers compared women who started combination hormone (estrogen+progestin) treatment within 10 years of menopause to women who began therapy more than 10 years after menopause and examined the impact on heart disease over time (up to eight years). The new study did not include women who took estrogen only.

The researchers reported a trend toward a possible increased risk of heart disease in the first two years among the women who started hormone therapy within 10 years after menopause and the increased risk persisted in this group an average of 6 years, after which those in the treatment group appeared to have a lower risk of heart disease compared to similar women who were not on combination hormone therapy.  In contrast, women who started hormone therapy 10 years or more after menopause were nearly 3 times more likely to develop heart disease within the first two years of treatment compared to women on placebo.   These women continued to be at increase risk of health disease throughout the 8 years of follow-up.

Jacques E. Rossouw, MD, chief of the NHLBI Women's Health Initiative Branch and a coauthor of the paper, added,  "Although the number of recently menopausal women who would be expected to suffer a heart attack during the first years of combination HT is small, the risk is likely to be real." In the NHLBI press release, acting director, Susan B. Shurin, MD, said, "Today, most women who take hormone therapy for menopausal symptoms begin therapy shortly after menopause.  Based on today's study, even these women appear to be at increased risk of heart disease for several years after starting combination hormone therapy."  This new data reinforces the need for women to  discuss their potential risk for cardiovascular disease and for other conditions like stroke and  breast cancer with their doctors when considering combination HT.

So what have we learned from this study?    Women who start combination HT to treat the symptoms of menopause within 10 years of menopause, should not expect the treatment to protect them from heart attacks, and may even have a possible slight increase in risk.   As with many studies, the statistical significance of the women in the study may not be sufficient to make this the final word on the topic but it is unlikely that additional information on the scale of this study will be available in the near future.

Posted by on February 15, 2010 - 10:05am

We realize that Thursday nights are jam packed with all sorts of great TV shows, but hopefully you were able to set the DVR for the WTTW series Health Secrets:  What Every Woman Should Know.  The 4-part TV series was hosted by Paula Zahn and sponsored by Northwestern Memorial Hospital and Alberto Culver.  Each one-hour program was aimed at addressing women's health needs at all stages of life. Topics ranged from vaccinating young girls (and boys) against HPV to Oncofertility to the importance of clinical research participation to the serious risk of heart disease and stroke in women.  No doubt each show was full of important and useful health information!  If you missed the series or do not get WTTW, you can watch segments from all the shows and obtain any information you need online at http://www.wttw.com/main.taf?p=1,57.

Over the past 4 weeks, an underlying theme was made pretty apparent - we just don't know enough.  In order to achieve the goal of personalized medicine, we must first better understand the differences in health and illness in men and women.  As we continue to conduct research that will bring about the next medical breakthroughs we need to focus on the necessity of educating the population about the clinical research process and why participation is key.  The Illinois Women’s Health Registry (https://whr.northwestern.edu), highlighted in show #3, serves as a resource for research and education that advances scientific knowledge of sex- and gender-based differences in health and disease.  If you want to observe what a powerful tool this Registry is becoming, please view the video below.

[video http://www.wttw.com/main.taf?p=72,9,2&pid=Fan7kByLCJDnJJaChFFiamvET7d_zFi9 here]

Both Drs Woodruff and Bristol-Gould are featured, in addition to a Registry participant who was interviewed about her experiences while enrolled in a knee osteoarthritis study.

If you haven't already enrolled, please get involved today.  https://whr.northwestern.edu

Posted by on February 10, 2010 - 3:45pm

A few decades ago, manicures and pedicures were something your grandmother and her friends did. Today, it has become popular with all ages--probably due to the general acceptance that women could pack away their panty hose and go bare-legged and the popularity of flip flops. As the consumer base widened, so did the number of nail salons, from store front services that featured express nail polish repair to high-end spas that offered a wide range of nail services that included organic and luxury cream treatments.  According to Jobbank.usa, there are over 78,000 manicurists in this country.

So who regulates these services and are they safe? Nail salons and technicians are license or certified  at the state level often under the category of Cosmetology. Each state has its own licensing/regulatory agency and rules.  These agencies regulate services ranging from acupuncturists to barbers to veterinary technicians.    Generally, the regulations are set by state law and include very specific guidelines that address safety and cleanliness.  The agency is responsible for oversight.  However, a call to one such agency confirmed my suspicion that in these trying fiscal times, there is little staff to visit the thousands of establishments under their jurisdiction.

So what is a girl/woman to do?

First of all, what are the risks?   Podiatrists report that skin and nail infections are seen in people who frequent nail salons and pedicures seem to be of special concern.  Even if the risk is low, it takes only one infection to create a health problem.   If a salon is vigilant and follows industry and government standards,  they can be perfectly safe.  If not, the list of possible problems is pretty gross so they are not listed here.

It is really up to the customer to decide if she feels a particular salon is keeping up its standards.   Here is a list of questions you can ask before booking:

  • Does the salon have a license to operate from the state? (it should be posted somewhere)
  • Is your technician either certified or licensed by the state?  If your technician is from another country or another state, she is still required to be licensed where she practices.
  • How does the salon clean its tools? (it takes more than 10 minutes for tools to be sterilized in a sterilizer or 25 minutes if UV light is used; a quick spritz of alcohol is not enough)
  • How is the pedicure bath cleaned between clients?  (unscrubbed tubs are a breeding ground for fungal and bacterial infections including staph; also jet tubs can be particularly unsafe if the filter is not changed frequently)

Are there some things you can do to protect yourself if you do have frequent pedis and manis?

  • Bring your own tools (some salons will store them for you)
  • Avoid cutting cuticles and  using a razor to shave calluses.
  • Do not shave your legs before your appointment.
  • Do not be shy if you see something you feel is unsafe--point it out to the owner.

If you are truly adventurous and want to try a fish pedicure or fish therapy, a recent fad where you put your feet in a tub filled with tiny fish that eat away dead skin, please beware.  Sanitizing fish in accordance with most sanitation standards, would most certainly kill the fish!  Several states have posted alerts indicating this treatment is not safe.

Posted by on February 9, 2010 - 11:01am

I have noticed that recently there have been a lot of commercials on television about getting your BRACAnalysis®.  You might be wondering what a BRAC analysis is? Or maybe you are wondering if you should get one?  The BRAC test is a genetic test that will test your genome for the presence of two genes that have been correlated with certain types of breast and ovarian cancer.

Mutations in these genes, known as BRCA1 and BRCA2, are strongly associated with 7% of breast cancers and 11-15% of ovarian cancers (1).  In most people, the BRCA genes are tumor suppressors, meaning they encode proteins that help regulate cell growth.   When these genes are mutated, they can lose their ability to control cell growth, and cancer can thus develop.  However, it is important to realize that not every woman who has a mutated BRCA1 or BRCA2 gene will develop cancer.  About 12% of the general population of women will develop breast cancer; while approximately 60% of women with a BRCA mutation will develop breast cancer.  Similarly, about 1.4% of women will develop ovarian cancer, compared to 15-40% of women with a BRCA mutation.  However, since these two genes are only associated with certain types of breast and ovarian cancer, a negative test (no mutation) does not guarantee that you will not develop cancer at some point in your lifetime (2).

Because the genes are located on the autosomal chromosomes (as opposed to the sex chromosomes), the mutation can be inherited from either your mother or your father.  Most women who decide to undergo genetic BRCA testing have a family history of breast or ovarian cancer.  However, there are no current medical guidelines for recommending BRCA tests.   Also, having a family member with the mutation does not necessarily mean you will have it to.  Once a woman tests positive for either BRCA1 or BRCA2, she has several options to help reduce her risk.  The most conservative options would be to monitor the breast and ovarian tissue with frequent screenings such as mammography or ultrasound.  More drastic options include removing the breast tissue and/or ovaries before cancer has a chance to develop, or taking chemotherapeutic drugs to help prevent cancer (clinical trials have demonstrated some success of these drugs in prevention of breast cancer).

A BRAC analysis test usually involves collection of a blood sample, and could cost you anywhere from several hundred to several thousand dollars, and it may not be covered by your insurance company.  The good news however, is that the Genetic Information Nondiscrimination Act of 2008 prevents discrimination from insurance companies or employers against people who have undergone genetic testing.  With personalized medicine on the rise, many individuals are concerned that their genetic information might be sold to employers and insurance providers and used to exclude them from employment or health coverage.  This law is meant to protect an individual’s right to privacy with his or her genetic information.

Ultimately it is your decision if you would like to undergo genetic testing.  It is important, however, to think about the emotional stress of undergoing such a test and receiving your results.  You might want to think beforehand about what you would do with the information.  If your test is positive, would you elect for preventative surgery?  Will your insurance cover early screening if you think you need it?  Knowing your risk can be both empowering and daunting.  I recently watched a wonderful documentary by filmmaker Joanna Rudnick, titled In the Family, that explores her own emotional struggle with genetic testing for breast and ovarian cancer.  View the trailer below:

To learn more about the film click here.

1.  Claus EB, Schildkrauten JM, Thompson WD, Risch NJ, et al. The genetic attributable risk of breast and ovarian cancer. Cancer. 1996;77:2318-2324.

2.  National Cancer Institute Fact Sheet on BRCA1 and BRCA 2. http://www.cancer.gov/templates/doc.aspx?viewid=ABCB7812-A132-4E78-A532-F002C92FA9B9

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