I have noticed more and more of my clients using the osteoporosis medication Prolia. Many of them were on bisphosphonates (like Fosamax) but are now receiving a twice a year Prolia injection.
I was curious about this recent change and asked Kent MacLeod, Clinical Pharmacist and Owner of NutriChem Compounding Pharmacy and Clinic in Ottawa, to provide a balanced assessment of this drug. (There is a transcript of the video interview at the end of this article).
While I have my reservations about the frequent use of bisphosphonates and other osteoporosis drugs, I believe that they play an important (and essential) role for clients who are at a significant risk of fracture.
It has been shown to be very effective when compared to bisphosphonates, but it is not as strong a medication as Forteo.
Prolia Side Effects
Kent’s major concern is the newness of the medication. It has not been around long enough to truly know its long term effects.
Prolia is working in a new way (compared to bisphosphonates). It is interfering with the immune system and affecting important cells called T lymphocytes.
AMGEN, the manufacturer of Prolia, states that the drug is for women with postmenopausal osteoporosis at high risk for fracture.
Kent’s concern is that women with low bone density or osteopenia start to use the drug as a means to prevent osteoporosis. His suggestion is that you should make sure that your health provider complete a thorough fracture risk assessment before prescribing this or any osteoporosis medication.
NutriChem is a compounding pharmacy, laboratory and clinic that uses research, individual testing and education to provide people with science-based solutions to their health problems. When clients with bone health issues visit NutriChem they receive a thorough health assessment and a balanced treatment program.
Kent makes sure that clients who are on osteoporosis medications, such as Prolia, receive a fracture risk assessment to ensure that their medication is appropriate for their fracture risk.
I frequently work with Kent and encourage my clients who need this level of assessment to visit Kent at NutriChem.
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Video and Transcript
Transcript – Scroll Bar is on the Right Hand Side
So Prolia is a new drug and it’s innovative in that it’s the first directed human immunoglobulin monoclonal antibody. So it’s actually working on the immune system and what it does is it interferes with this protein called RANK-Ligand protein, which actually affects osteoclasts and it actually prevents their formation and maturation and their survival rates and so what happens really is that Prolia is working by affecting the whole remodelling of bone.
It’s actually similar in mechanism of action to the bisphosphonates that everyone is most familiar with, but this is working on the immune system and that sort of mechanism whereas bisphosphonates are more of a chemical interaction, so it’s very, very different, but similar in mechanism of action to bisphosphonates but it’s working on the immune system.
Again, there have been several large studies showing significant benefits, both to fracture rates and improvements in bone density. It’s been compared in one study to the bisphosphonate Alendronate and again it’s shown superior results in fracture and bone density to the bisphosphonates.
Of course, of concern is the more serious potential where there’s potential lowering of blood calcium, higher rates of infections, even higher rates of skin problems. And also in several of these studies higher rates of cancer, but not being significant at this point.
This is of course the concern, is that it’s working in a new way, it’s interfering with the immune system, which of course has a role, particularly those very important cells called T-lymphocytes, which are very important in the immune system. So is it increasing rates of infections or cancers or some other conditions that we weren’t aware of and that we have only a 3-year study, so the longest it’s been studied is 3 years and there’s some extensions of the existing study, which are going as long as 5 years.
Absolutely, that’s the big concern isn’t it? What is happening in the long term with this drug. I think this is what happened with the bisphosphonates is you have this migration to preventative to people who are at very low risk of an actual fracture being prescribed drugs preventatively. We really want to be cautious with Prolia, which is a new mechanism of action which affects immune system, which has potentially some serious, long-term effects which we aren’t aware of over time. That it is absolutely used in people who are at the most risk of actually having a fracture. People that have high risk of an actual osteoporotic fracture and that it is not used until more data is available in people who are at low to moderate risk or no risk or being used preventatively.
So when I use that word of concern I think that’s very, very strong, but I think it’s really important that people use it appropriately and they’re using other very well established and safe treatments for mild to moderate or prevention, which is exercise and nutrition.
In the drug-only options I think certainly it’s more effective in the current studies than bisphosphonates. It’s certainly not as powerful as Forteo, but it has some advantages in that it doesn’t interact with some other drugs, it doesn’t have some of the esophageal effects, it’s very convenient in dosing and it seems to have very little effects in terms of problems with respect to kidney clearance and liver function, so it has kind of unique profile. The big concern of course, is what is it doing in the long term and is it being reserved for currently at-risk patients. So you don’t want to cause all these problems long term that are more dangerous than the actual drug, the risk of a fracture, so that’s the main concern.
When people are arriving here, we’re looking at all their drugs, insuring that there’s not other agents that are interfering with their bone density. We want to make sure that they’re using a superior exercise program. We do assessments and measure their actual vitamin D levels, so that it’s not left to chance. Because they are variations in absorption of vitamin D, so we insure that all our clients are above 100 nanamoles per liter of 25-hydroxy vitamin D. We establish adequate calcium intake at a minimum of 500 milligrams per day. We assess other nutrients, and other functions in the body that have been proven to increase bone density. So we’re trying to create a very holistic approach in our recommendations.
Margaret Martin is a Physical Therapist, Certified Strength and Conditioning Specialist (CSCS) and Certified Yoga Teacher with over 27 years experience helping clients achieve their health and fitness goals.
She treats clients with low bone density at her clinic and teaches fellow Health Professionals how to treat osteoporosis.
Margaret is the recipient of the 2011 Award of Distinction from the College of Physiotherapists of Ontario for her significant contributions and achievements as a Physiotherapist.