Emerging Treatments for Osteoporosis and Osteopenia
Allison Hahr, MD, is the director of the Northwestern Medicine Bone Health and Osteoporosis Program and an associate professor in the Division of Endocrinology Metabolism and Molecular Medicine. In this episode of the Better Edge Podcast, she discusses the challenges of diagnosis, treatment and medication adherence for osteoporosis and osteopenia. She also shares emerging treatment options including a new class of therapeutics, a monoclonal sclerostin antibody called romosozumab, which is the first medication that is known to have a dual effect—it is both anabolic and antiresorptive.
Featured Speaker:
Allison Hahr, MD
Dr. Hahr is interested in disorders of endocrinology. She specializes in disorders of calcium and bone, including osteoporosis, hyperparathyroidism and vitamin D deficiency. She also cares for patients within general endocrinology including patients with a variety of thyroid disorders, diabetes mellitus, polycystic ovary syndrome, and pituitary disease. Transcription:
Emerging Treatments for Osteoporosis and Osteopenia
Melanie Cole: Welcome to Better Edge, a Northwestern Medicine Podcast for physicians. I'm Melanie Cole, and I invite you to listen. As we discuss emerging treatments and research for osteoporosis. Joining me is Dr. Alison Hahr. She's the Director of Bone Health and Osteoporosis Program in the Division of Endocrinology Metabolism and Molecular Medicine. And she specializes in calcium disorders and osteoporosis at Northwestern Medicine. Dr. Hahr, it's a pleasure to have you with us. And before we get into osteoporosis and calcium disorders, tell us a little bit about your specialty area and your role in the division of endocrinology at Northwestern Medicine?
Dr. Hahr: As mentioned, I'm an endocrinologist at Northwestern and I have a sub-specialty focus in osteoporosis. And that also includes metabolic bone disorders like rickets and calcium disorders, such as hyperparathyroidism, I'm the clinical director for endocrinology. And I'm also the director of the Bone Health and Osteoporosis Clinic at Northwestern.
Host: Thank you for that. So while pretty common osteoporosis is a challenging condition to treat because it doesn't always show symptoms until maybe a fracture happens or something like that. Can you tell us a little bit about some of the screening prevention and even the early interventions that your team has implemented?
Dr. Hahr: Sure. You're absolutely right. That it can be challenging because it is oftentimes asymptomatic and therefore osteoporosis can go underdiagnosed and therefore undertreated, because as mentioned, there's really no symptoms aside from having a fracture. Osteoporosis otherwise doesn't cause pain unless there is of course pain related to having a broken bone. So we do recommend that women have a screening bone density, all women around age 65, but they should have a sooner bone density based on their risk profile. So that could mean that they have a high risk family history that they've had prior. What we call are fragility fractures, meaning a fracture that occurs with very little trauma or maybe they are undergoing cancer treatment. And they're on anti-estrogen maybe they're on steroids or they've had a transplant. And I also want to point out that Osteoporosis also affects men. So actually about one in five patients who have Osteoporosis are men.
So, some men do warrant, a screening bone density as well. And that will be a man who's had fragile fractures, hypogonadism, certain medical conditions, and high-risk medications such as steroids as already mentioned. But because osteoporosis can be asymptomatic, it does present a challenge when trying to get patients to take a medication for treatment. Most patients buy into the idea of doing a bone density, but we as physicians and providers are really trying to prevent that fracture from occurring, it's called primary prevention, or if a fracture has already, we call it secondary prevention. And this create the challenge because many patients feel well on a regular basis and they have no symptoms. And so they may be a little bit more reluctant to treating Osteoporosis. In our clinic, we of course encourage checking bone densities on our regular basis. Also known as a DEXA. These are easy, they're low cost.
They're fairly quick to perform and they're low radiation. I would say the test to do a bone density takes about five to 10 minutes at the most. And in our bone health clinic, we have our own DEXA machine and we currently have the latest model and software in place. We also have another modality called a vertebral fracture analysis, also known as the VFA. And that is part of the DEXA machine. It's not as readily known, but it's done or it can be done at the same time as the DEXA, if it's ordered. And it's similar to an x-ray, but it's through the DEXA machine. So it's a lateral view through the spine. And it's convenient for patients because it is part of the DEXA machine. So they're already there, it's lower costs and it's also lower radiation compared to doing an x-ray. And I would say, this is really best for detecting moderate or severe spine fractures, mostly in the thoracic and lumbar spine region. And it's helpful in patients who perhaps either have kyphosis or height loss and are wondering if they have had a spine fracture that's gone undiagnosed.
And then in our clinic, in our DEXA machine, we also have the latest software provide yet another modality to predict fracture risk. And it's called the trabecular bone score or TBS for short. And the TBS is an actual number provided by the software. And we like it because it gives information about bone structure. So the bone density or DEXA as the name applies, gives the bone density, but this gives info about bone structure, and it actually uses the data from the lumbar spine BMD measurements. So a higher TBS score is better because indicators more correctly present and therefore implies that there is better bone structure. And the TBS is meant to be used as a compliment to the DEXA. So together they can provide information that helps our ability to predict what a patient's fracture risk is.
Host: Then speak a little bit, and I'm glad you mentioned men, Dr. Hahr, but speak a little bit about the link between osteoporosis menopause, estrogen. If women are on hormone replacement, tell us how that all ties together as a risk factor?
Dr. Hahr: So, the most common reason or very common cause of osteoporosis is aging. And for women that will mean going into menopause. So the drop in estrogen levels is clearly linked to bone loss and an increased risk for developing osteopenia and osteoporosis. Men can also have hypogonadism, and that would be a major risk factor for developing osteoporosis or bone loss for men. Hormone replacement therapy can prevent bone loss in women, but there are of course risks taking hormone replacement therapy for some women, especially as they are older or further away from menopause. So we also need to consider other medications that are effective in preventing bone loss and reducing fractures.
Host: Well, that segues beautifully into the current standard of treatment for osteoporosis. How has it evolved over the years? And please speak about some of the latest medications available to help with bone density. We hear about concerning side effects when other providers and primary care providers are prescribing these, tell us a little bit about what they're doing, how they work and side effects that you've heard from patients?
Dr. Hahr: There are a number of effective treatments available for osteoporosis. We're lucky that we have a growing pool of medications. And when we think about the medications, we generally categorize them into two categories. One is that there are medications known as antiresorptive agents meaning they slow osteoclasts and therefore slow bone loss or medications can be thought of as being anabolic, meaning they promote osteoblast function and therefore promote bone growth. Historically, the antiresorptive known as stimuli responsive were among the first available medications for osteoporosis. And this was in the 1990s and they're often still considered first-line treatment for many patients, they are available both orally and IV. And some common examples would be weekly oral, alendronate or zoledronic acid, which has given IV once yearly. These are typically used for a finite time periods, such as three to five years, depending on which medication is started.
And then a drug quote unquote holiday is considered where they are taken off the medication. There is another antiresorptive medication known as the Denosamab, which became available about 2010. And it's a sub Q injection given every six months. Now, Denosamab is different in that it can't be stopped outright. So currently it's advised that if the Denosamab will be stopped, it should be followed by at desposanate afterwards. And then in terms of anabolic medications, the first anabolic that became available was in 2002, and that's teriparatide, which is a recombinant form of parathyroid hormone. And then in 2017, abaloparatide became the second available and anabolic and abaloparatide is somewhat similar, but it is a synthetic analog of parathyroid hormone related peptide. And both of those are daily sub Q injections that the patient gives to themselves at home. And they can be used for up to two years.
What's exciting is that the latest advances that we now have a new medication called Ramucirumab and it's a monoclonal antibody sclerostin antibody. And it's exciting that we have this new class of treatments. It was FDA approved in 2019, and it's actually the first medication that's known to have a dual effect. So it's actually both anabolic and antiresorptive. And that is given as a monthly sub Q injection for one year. All of the anabolic therapies do need to be followed by antiresorptive therapy. So it's important for the patients to know that. And we like to think about both classes of medications as being important. Antibiotics are not as commonly perhaps used or known about, but it's important to be aware of them because they can be offered as first-line therapy in patients who are considered to be a higher risk for fracture. So those may be patients who've already had a spine or hip fracture patients who have multiple fragility fractures, those that have had, or have very low key scores on a DEXA, or perhaps those who still have osteoporosis, but have failed other treatments or just need ongoing treatment.
Host: Well, then tell us about some of the challenges as you're telling us about all these medications. Tell us about some of the challenges physicians face when treating people with osteoporosis or osteopenia, or if they've suffered a fracture, is adherence an issue, whether it's to the medication or to diet suggestions, exercise, strength training, any of those kinds of things. What are some of the challenges in doing what you do?
Dr. Hahr: I think there's definitely challenges with osteoporosis. All disorders of most patients are pretty good about diet, Calcium, Vitamin D, and exercise of course, within the realms of practicality. Treating osteoporosis, just like all of medicine is really an art in a science. In terms of the science component. We have great science and studies showing that the medications we have are efficacious and have pretty good safety, but certainly there's a lot of confusion and debates about which medications should be used and when, so we try to do our best to risk stratify patients into the low, moderate, or high fracture risk. For example, if we think somebody has high risk of a future fracture, that might be somebody who's had a new or recent spine or hip fracture. So we really want to identify those patients who have high-risk let them know that they're high risk and counsel them to start treatments.
But you may have noticed that the use of osteoporosis medications has really dropped quite a bit in the last 10 years and accordingly fractures have increased. And this decrease in use is really related to growing concerns, my patients over some of the adverse side effects. So there's just a lot of fear on taking some of these medications. One side-step that's gotten a lot of press is osteonecrosis of the jaw, also known as ONJ and atypical femur fractures. And these are very rare, but of course are serious side effects. So we try to do our best to counsel patients on what their risk is of having a future broken bone. If somebody is fairly low risk, then we would encourage them to do healthy diets, Calcium, Vitamin D, exercise, healthy habits, but perhaps they don't need some of the more robust medications, but if somebody is high risk, we want them to do all of the healthy lifestyle changes, but also frankly, consider a medication.
And so, this is where the art comes in, because that can be a major challenge. And we really want to emphasize just like with any disorder, that patient choice and input is super important it's of course always important, but it seems to be particularly important in this osteoporosis discussion, given that there is so much fear about medications. And that having osteoporosis, as we talked about already can be asymptomatic. So it's super helpful to take patient preferences into account, since compliance and the buy-in from the patient is really key for success. And this takes time, which we oftentimes maybe don't have enough of always in a single appointment. But what we try to do is try to provide patients with knowledge regarding what medication we think should be used and why, what the evidence is of regarding efficacy. And then also letting them know about side effects and which ones are common and which ones are rare. And that's something that patients do want to hear and they want to have this in-depth discussion.
And then you also have to take into consideration things like maybe they have a fear of needles or a fear of infusions. Perhaps they travel a lot or they find the way that they take the medication is not desirable and their quality of life or their busy lifestyle. And then things like costs are also important. And perhaps they live in Chicago half the time, or they live maybe in California or Florida half the time. So that also needs to be taken into account. So it's important that the patient feel that they are empowered to make an educated decision about what's best for them, because in the end we want the patient to participate and also take the medication for it to be successful in the long run.
Host: You make such great points, Dr. Hahr, and yes, we have seen a lot of negative information. So, I imagine that is quite a challenge when explaining those meds to patients, as we wrap up, tell us about some interesting new research advances in the field of calcium disorders, osteoporosis, any new research you're working on? And what you'd like other providers to know about the program at Northwestern Medicine? And when you feel it's important, they refer?
Dr. Hahr: One interesting new development is that abaloparatide currently available as a daily sub Q injection for patients to give to themselves at home. But as you can imagine, that's not for everybody there's many who are squeamish or are not interested. So there's an ongoing trial looking at a patch form of abaloparatide that the patient would apply at home. And so far the data perhaps looks like it could be promising. And historically we have used one anti-oppressive medication at a time. So, we don't use, for example, usually teriparatide and Denosamab at the same time, but there's some interesting evolving research regarding using more than one osteoporosis treatment in combination for very high risk patients. I think it's helpful for doctors who are treating osteoporosis is that there's a number of great guidelines, including guidelines from the Endocrine Society and the American Association of Clinical Endocrinologists and the provide great information about treating osteoporosis and the medications. And I think that the National Osteoporosis Foundation, which is readily available on the internet as also a great resource, both for clinicians and physicians, but also for the patients. And in our clinic, we're just here to help and happy to see patients. We particularly like seeing patients who have more advanced disease and who are at high risk of fracture, but we're really interested in treating osteoporosis and preventing fractures.
Host: Thank you so much, Dr. Hahr, what an exciting time to be in your field. Thank you for sharing your expertise with us today. And that concludes this episode of Better Edge, a Northwestern Medicine Podcast for physicians. To refer your patient, or for more information, please visit our website at nm.org to get connected with one of our providers. Please also remember to subscribe, rate, and review this podcast and all the other Northwestern Medicine podcasts. I'm Melanie Cole.
Emerging Treatments for Osteoporosis and Osteopenia
Melanie Cole: Welcome to Better Edge, a Northwestern Medicine Podcast for physicians. I'm Melanie Cole, and I invite you to listen. As we discuss emerging treatments and research for osteoporosis. Joining me is Dr. Alison Hahr. She's the Director of Bone Health and Osteoporosis Program in the Division of Endocrinology Metabolism and Molecular Medicine. And she specializes in calcium disorders and osteoporosis at Northwestern Medicine. Dr. Hahr, it's a pleasure to have you with us. And before we get into osteoporosis and calcium disorders, tell us a little bit about your specialty area and your role in the division of endocrinology at Northwestern Medicine?
Dr. Hahr: As mentioned, I'm an endocrinologist at Northwestern and I have a sub-specialty focus in osteoporosis. And that also includes metabolic bone disorders like rickets and calcium disorders, such as hyperparathyroidism, I'm the clinical director for endocrinology. And I'm also the director of the Bone Health and Osteoporosis Clinic at Northwestern.
Host: Thank you for that. So while pretty common osteoporosis is a challenging condition to treat because it doesn't always show symptoms until maybe a fracture happens or something like that. Can you tell us a little bit about some of the screening prevention and even the early interventions that your team has implemented?
Dr. Hahr: Sure. You're absolutely right. That it can be challenging because it is oftentimes asymptomatic and therefore osteoporosis can go underdiagnosed and therefore undertreated, because as mentioned, there's really no symptoms aside from having a fracture. Osteoporosis otherwise doesn't cause pain unless there is of course pain related to having a broken bone. So we do recommend that women have a screening bone density, all women around age 65, but they should have a sooner bone density based on their risk profile. So that could mean that they have a high risk family history that they've had prior. What we call are fragility fractures, meaning a fracture that occurs with very little trauma or maybe they are undergoing cancer treatment. And they're on anti-estrogen maybe they're on steroids or they've had a transplant. And I also want to point out that Osteoporosis also affects men. So actually about one in five patients who have Osteoporosis are men.
So, some men do warrant, a screening bone density as well. And that will be a man who's had fragile fractures, hypogonadism, certain medical conditions, and high-risk medications such as steroids as already mentioned. But because osteoporosis can be asymptomatic, it does present a challenge when trying to get patients to take a medication for treatment. Most patients buy into the idea of doing a bone density, but we as physicians and providers are really trying to prevent that fracture from occurring, it's called primary prevention, or if a fracture has already, we call it secondary prevention. And this create the challenge because many patients feel well on a regular basis and they have no symptoms. And so they may be a little bit more reluctant to treating Osteoporosis. In our clinic, we of course encourage checking bone densities on our regular basis. Also known as a DEXA. These are easy, they're low cost.
They're fairly quick to perform and they're low radiation. I would say the test to do a bone density takes about five to 10 minutes at the most. And in our bone health clinic, we have our own DEXA machine and we currently have the latest model and software in place. We also have another modality called a vertebral fracture analysis, also known as the VFA. And that is part of the DEXA machine. It's not as readily known, but it's done or it can be done at the same time as the DEXA, if it's ordered. And it's similar to an x-ray, but it's through the DEXA machine. So it's a lateral view through the spine. And it's convenient for patients because it is part of the DEXA machine. So they're already there, it's lower costs and it's also lower radiation compared to doing an x-ray. And I would say, this is really best for detecting moderate or severe spine fractures, mostly in the thoracic and lumbar spine region. And it's helpful in patients who perhaps either have kyphosis or height loss and are wondering if they have had a spine fracture that's gone undiagnosed.
And then in our clinic, in our DEXA machine, we also have the latest software provide yet another modality to predict fracture risk. And it's called the trabecular bone score or TBS for short. And the TBS is an actual number provided by the software. And we like it because it gives information about bone structure. So the bone density or DEXA as the name applies, gives the bone density, but this gives info about bone structure, and it actually uses the data from the lumbar spine BMD measurements. So a higher TBS score is better because indicators more correctly present and therefore implies that there is better bone structure. And the TBS is meant to be used as a compliment to the DEXA. So together they can provide information that helps our ability to predict what a patient's fracture risk is.
Host: Then speak a little bit, and I'm glad you mentioned men, Dr. Hahr, but speak a little bit about the link between osteoporosis menopause, estrogen. If women are on hormone replacement, tell us how that all ties together as a risk factor?
Dr. Hahr: So, the most common reason or very common cause of osteoporosis is aging. And for women that will mean going into menopause. So the drop in estrogen levels is clearly linked to bone loss and an increased risk for developing osteopenia and osteoporosis. Men can also have hypogonadism, and that would be a major risk factor for developing osteoporosis or bone loss for men. Hormone replacement therapy can prevent bone loss in women, but there are of course risks taking hormone replacement therapy for some women, especially as they are older or further away from menopause. So we also need to consider other medications that are effective in preventing bone loss and reducing fractures.
Host: Well, that segues beautifully into the current standard of treatment for osteoporosis. How has it evolved over the years? And please speak about some of the latest medications available to help with bone density. We hear about concerning side effects when other providers and primary care providers are prescribing these, tell us a little bit about what they're doing, how they work and side effects that you've heard from patients?
Dr. Hahr: There are a number of effective treatments available for osteoporosis. We're lucky that we have a growing pool of medications. And when we think about the medications, we generally categorize them into two categories. One is that there are medications known as antiresorptive agents meaning they slow osteoclasts and therefore slow bone loss or medications can be thought of as being anabolic, meaning they promote osteoblast function and therefore promote bone growth. Historically, the antiresorptive known as stimuli responsive were among the first available medications for osteoporosis. And this was in the 1990s and they're often still considered first-line treatment for many patients, they are available both orally and IV. And some common examples would be weekly oral, alendronate or zoledronic acid, which has given IV once yearly. These are typically used for a finite time periods, such as three to five years, depending on which medication is started.
And then a drug quote unquote holiday is considered where they are taken off the medication. There is another antiresorptive medication known as the Denosamab, which became available about 2010. And it's a sub Q injection given every six months. Now, Denosamab is different in that it can't be stopped outright. So currently it's advised that if the Denosamab will be stopped, it should be followed by at desposanate afterwards. And then in terms of anabolic medications, the first anabolic that became available was in 2002, and that's teriparatide, which is a recombinant form of parathyroid hormone. And then in 2017, abaloparatide became the second available and anabolic and abaloparatide is somewhat similar, but it is a synthetic analog of parathyroid hormone related peptide. And both of those are daily sub Q injections that the patient gives to themselves at home. And they can be used for up to two years.
What's exciting is that the latest advances that we now have a new medication called Ramucirumab and it's a monoclonal antibody sclerostin antibody. And it's exciting that we have this new class of treatments. It was FDA approved in 2019, and it's actually the first medication that's known to have a dual effect. So it's actually both anabolic and antiresorptive. And that is given as a monthly sub Q injection for one year. All of the anabolic therapies do need to be followed by antiresorptive therapy. So it's important for the patients to know that. And we like to think about both classes of medications as being important. Antibiotics are not as commonly perhaps used or known about, but it's important to be aware of them because they can be offered as first-line therapy in patients who are considered to be a higher risk for fracture. So those may be patients who've already had a spine or hip fracture patients who have multiple fragility fractures, those that have had, or have very low key scores on a DEXA, or perhaps those who still have osteoporosis, but have failed other treatments or just need ongoing treatment.
Host: Well, then tell us about some of the challenges as you're telling us about all these medications. Tell us about some of the challenges physicians face when treating people with osteoporosis or osteopenia, or if they've suffered a fracture, is adherence an issue, whether it's to the medication or to diet suggestions, exercise, strength training, any of those kinds of things. What are some of the challenges in doing what you do?
Dr. Hahr: I think there's definitely challenges with osteoporosis. All disorders of most patients are pretty good about diet, Calcium, Vitamin D, and exercise of course, within the realms of practicality. Treating osteoporosis, just like all of medicine is really an art in a science. In terms of the science component. We have great science and studies showing that the medications we have are efficacious and have pretty good safety, but certainly there's a lot of confusion and debates about which medications should be used and when, so we try to do our best to risk stratify patients into the low, moderate, or high fracture risk. For example, if we think somebody has high risk of a future fracture, that might be somebody who's had a new or recent spine or hip fracture. So we really want to identify those patients who have high-risk let them know that they're high risk and counsel them to start treatments.
But you may have noticed that the use of osteoporosis medications has really dropped quite a bit in the last 10 years and accordingly fractures have increased. And this decrease in use is really related to growing concerns, my patients over some of the adverse side effects. So there's just a lot of fear on taking some of these medications. One side-step that's gotten a lot of press is osteonecrosis of the jaw, also known as ONJ and atypical femur fractures. And these are very rare, but of course are serious side effects. So we try to do our best to counsel patients on what their risk is of having a future broken bone. If somebody is fairly low risk, then we would encourage them to do healthy diets, Calcium, Vitamin D, exercise, healthy habits, but perhaps they don't need some of the more robust medications, but if somebody is high risk, we want them to do all of the healthy lifestyle changes, but also frankly, consider a medication.
And so, this is where the art comes in, because that can be a major challenge. And we really want to emphasize just like with any disorder, that patient choice and input is super important it's of course always important, but it seems to be particularly important in this osteoporosis discussion, given that there is so much fear about medications. And that having osteoporosis, as we talked about already can be asymptomatic. So it's super helpful to take patient preferences into account, since compliance and the buy-in from the patient is really key for success. And this takes time, which we oftentimes maybe don't have enough of always in a single appointment. But what we try to do is try to provide patients with knowledge regarding what medication we think should be used and why, what the evidence is of regarding efficacy. And then also letting them know about side effects and which ones are common and which ones are rare. And that's something that patients do want to hear and they want to have this in-depth discussion.
And then you also have to take into consideration things like maybe they have a fear of needles or a fear of infusions. Perhaps they travel a lot or they find the way that they take the medication is not desirable and their quality of life or their busy lifestyle. And then things like costs are also important. And perhaps they live in Chicago half the time, or they live maybe in California or Florida half the time. So that also needs to be taken into account. So it's important that the patient feel that they are empowered to make an educated decision about what's best for them, because in the end we want the patient to participate and also take the medication for it to be successful in the long run.
Host: You make such great points, Dr. Hahr, and yes, we have seen a lot of negative information. So, I imagine that is quite a challenge when explaining those meds to patients, as we wrap up, tell us about some interesting new research advances in the field of calcium disorders, osteoporosis, any new research you're working on? And what you'd like other providers to know about the program at Northwestern Medicine? And when you feel it's important, they refer?
Dr. Hahr: One interesting new development is that abaloparatide currently available as a daily sub Q injection for patients to give to themselves at home. But as you can imagine, that's not for everybody there's many who are squeamish or are not interested. So there's an ongoing trial looking at a patch form of abaloparatide that the patient would apply at home. And so far the data perhaps looks like it could be promising. And historically we have used one anti-oppressive medication at a time. So, we don't use, for example, usually teriparatide and Denosamab at the same time, but there's some interesting evolving research regarding using more than one osteoporosis treatment in combination for very high risk patients. I think it's helpful for doctors who are treating osteoporosis is that there's a number of great guidelines, including guidelines from the Endocrine Society and the American Association of Clinical Endocrinologists and the provide great information about treating osteoporosis and the medications. And I think that the National Osteoporosis Foundation, which is readily available on the internet as also a great resource, both for clinicians and physicians, but also for the patients. And in our clinic, we're just here to help and happy to see patients. We particularly like seeing patients who have more advanced disease and who are at high risk of fracture, but we're really interested in treating osteoporosis and preventing fractures.
Host: Thank you so much, Dr. Hahr, what an exciting time to be in your field. Thank you for sharing your expertise with us today. And that concludes this episode of Better Edge, a Northwestern Medicine Podcast for physicians. To refer your patient, or for more information, please visit our website at nm.org to get connected with one of our providers. Please also remember to subscribe, rate, and review this podcast and all the other Northwestern Medicine podcasts. I'm Melanie Cole.