Ellen Binder, MD, a Geriatrician at Washington University in St. Louis talks about helping women recover from hip fractures with exercise and a testosterone topical gel.
Give me an overview about why hip fractures are such a serious health threat to the aging population?
BINDER: Hip fractures are a serious threat to the aging population because a significant percentage of patients do not survive after the hip fracture. There’s about a 25 percent mortality rate within the first year. More importantly, for those who survive, up to 3/4 of them never get back to the functional level that they were at before they had the hip fracture.
Why is that 25 percent dying and where does that number come from?
BINDER: Many of these patients have medical problems before the hip fracture, like heart disease. They have become very weak and malnourished before the hip fracture. It’s, unfortunately, kind of a perfect storm of serious medical problems that occur because the patient is in kind of a weakened state when they break their hip.
When you say they don’t get back to their normal activities, are you saying that daily life is changed and they’re not going to get that back?
BINDER: There’s a huge variation within the 75 percent. For some people, it’s just the fact that they never get back to walking without a cane or a walker. However, they’re otherwise able to do a lot of things and maybe most of their activities which is very important to older adults. Many don’t want to be dependent on assistive devices. On the other extreme, there are people that must live in a nursing home before this occurred because they’re not able to do simple daily activities to be able to live independently. So, there’s a wide range that can affect many patients.
Tell me a little bit about the research that shows the benefits of extended physical therapy and even weight lifting and what you’re finding there.
BINDER: Many years ago, we did a large clinical trial looking at whether intensive and extended exercise in hip fracture patients would be beneficial relative to their mobility and their ability to do activities of daily living. We demonstrated that compared to the usual kinds of exercises that patients do after they’ve finished their standard physical therapy, those that did intensive exercise that included weight training gained much more mobility and strength and ability to do activities of daily living. I should mention that since then there have been several different kinds of exercise trials in hip fracture patients and not all of them have been successful because the kinds of exercises that they did were not as intensive. It is looking like doing weight training activities and more intense exercise is really a key in the hip fracture population to regain significant mobility and activities of daily living.
Can you explain a little bit when you say weight lifting and weight training? What does that mean?
BINDER: Sure. I need to emphasize that we don’t start out with weight training right away. We spend at least the first month of this exercise program in doing lower intensity exercises, flexibility exercises and walking to try to prepare the patients for doing weight training. Weight training is working with resistance exercises, so it’s pushing against a weight in some form. It could be lifting a small weight that is appropriate for that person’s strength and body size. It could be getting into what we call a weight machine where you’re pushing against a plate or pushing with some handles. But we have had great success. We’re very careful and no one has had any significant problems, and in fact, patients really enjoy this. They can quickly perceive that they are getting better, and they are getting stronger.
Is the benefit simply building muscle mass with weight lifting or are you improving bone strength?
BINDER: We think we’re doing both. What we’re focusing on is to build muscle strength. So, we want muscles and bones to work together. The resistance aspect of this exercise helps for bone remodeling and strengthening. But the functional aspect of this is really the muscles getting stronger, the walking getting better, and the balance getting better, so that people can do their activities and do them for longer periods of time and with more confidence.
Is there a difference with six months of physical therapy rather than whatever the standard therapy is? And, is there a standard?
BINDER: There is a standard, but it is not a specific length of time. The approach that most physical therapists take is that they come up with tailored goals for the patients for their mobility based on their assessment of the patient right after the fracture and where they were living, and where they think they’re going home to. Typically, after the hip fracture, therapy is done primarily either in a skilled nursing facility or at the patient’s home. It’s only a very small percentage of patients that go to an acute rehab hospital. If you go to a skilled nursing facility, on average patients will be there for about three weeks and then they’ll go home and get a couple more weeks of therapy. But the length of time really can vary quite a bit based on the individual patient’s needs and the way people practice in a region. Our intervention really does not start until after they finish this standard treatment in the standard nursing facility and at home. We designed it that way because at this point, it’s very difficult for us to be able to work in a lot of individual facilities and essentially compete with what Medicare provides for patients. But we hope that the model we’re evaluating will be able to be moved in to the acute training much sooner. Even though we’re doing this after standard therapy is finished, if we show this is successful, we think that they’re going to be able to apply some of the weight techniques and testosterone therapy sooner after the fracture.
Why try testosterone treatment for women specifically?
BINDER: Well we know in studies of men that testosterone does increase muscle strength particularly when it’s combined with exercise. However, there aren’t as many studies of women. We know from the world of sports where people have been using steroids for many years that it does enhance performance. So, we think it’s important to evaluate in women and particularly in women who are in a very weakened condition to see whether this can help to enhance their rehabilitation and essentially help jump start
What is the dose?
BINDER: We are using a topical gel, which is common. It is a commercially available FDA-approved product for testosterone replacement. This dose has been tested in younger women, mostly in the context of those with a low libido. We’re using the dose similar to what was used in younger studies of younger women but it’s approximately 1/4 of the dose that might be used in men.
Does it matter where it is applied?
BINDER: The recommended body area is upper arm like the shoulder. You could put it on the upper chest also. It is absorbed through the skin anywhere, but it’s advised to keep it on the upper body.
Does it have to be reapplied every day?
BINDER: Yes. It must be reapplied every day but can last longer than that. It has a relatively long half-life. That’s one of the advantages of using it topically.
What have your early studies shown?
BINDER: We cannot look at any results until the study is completed. We did a small pilot study roughly 10 years ago and showed that the women who received testosterone all tolerated it very well. There were no significant side effects. The women did have some increase in the amount of lean mass that we measured which is a way of measuring the amount of muscle and increased strength.
How does the increase in the amount of lean mass translate to their outcome?
BINDER: The degree of increase in muscle strength and muscle mass translates to improving physical function and mobility when it’s added to exercise. I can’t give any answers because it’s going to take us several years to finish the study and to analyze the results.
Is your study currently recruiting or do you have enough patients involved?
BINDER: We just started recruitment and need patients. We are doing this in six clinical centers around the country – Boston, University of Connecticut Health Center in Farmington, Connecticut, Baltimore, Galveston and close to some areas outside of Houston that are closer to Galveston, St. Louis, and Denver. There is potential we’ll add a couple of more sites.
Is the idea that they would take it during physical therapy and once physical therapy is over, the testosterone gel would stop? Is the hope that they would have these lasting effects but wouldn’t continue to need the testosterone?
BINDER: Yes. By kickstart it’s not an immediate effect that we’re talking about. Our intervention is a six-month intervention. So, this is a gradual process. What I mean by that is just augmenting over a few months’ time the kinds of gains that people would be able to make. We hope that they will be able to sustain them after the testosterone gel is discontinued because we are not designing this as something they need to take for the rest of their life.
What are the potential benefits for women who have hip fractures and go through this weight lifting and rubbing on testosterone gel treatment? Is it pretty low cost?
BINDER: In the big scheme of things this is a relatively low cost. We hope it will help keep women healthier after their hip fracture, more functional, and keep them at home longer, therefore reducing costs for health care and assistance and even possible nursing home placement. We also hope if we can demonstrate this is successful with the hip fracture population, there could be other studies of other types of surgical procedures. I was with an orthopedic surgeon who does knee replacements and he was very enthusiastic that this could be helpful to improve outcomes after knee or hip replacements. There is now an interest in what we call pre-hab, which is rehabilitating the person prior to the surgery so that they’re as strong as possible when they undergo the surgery and have a quicker recovery. There may be applications for other medically weak populations as well.
What’s the next step? Since this is already an FDA-approved product, could this be enough to be offered to patients within a few years?
BINDER: I think it will depend on what we find in the results and that’s going to be several years away. We are not seeking nor is any drug company seeking approval of testosterone as an indication after hip fracture. So, even if we show this is successful, it’s likely it will be an “off label” application. But, better to do it with good proof that it will show benefit because there are costs and always side effects to medications. We shouldn’t prescribe anything particularly in older and frail adults that isn’t going to be a benefit.
Is there anything we should touch on or is there anything you want to add?
BINDER: I’d only add that the women who are enrolled in the trial are greatly enjoying it and all doing well. I know it seems intimidating to women after a hip fracture or to their family members, but this is a huge benefit to those that enroll in this study. No matter which group they’re in, they’re getting extra exercise and physical therapy and a motivation to stay healthy. We address their nutrition and there’s probably benefit to just being in the study. Women who are in our enhanced usual care group which is a home-based exercise program, they love the home-based exercise. I mean some people even prefer that because it’s at home. But they appreciate getting some extra attention and motivation to do exercise and to be healthy.
END OF INTERVIEW
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