An Introduction of a New Class for the Treatment of Bone Health - Episode 12
Peter L. Salgo, MD: You started to talk about these new, novel agents that are out there, and I promised we would get to them. Now it’s time to keep our promise. What are the sclerostin inhibitor treatment options that are out there?
Andrea J. Singer, MD, FACP, CCD: Well, there’s 1. This is the newest agent, which was actually approved during the second week in April. So it is brand new.
Peter L. Salgo, MD: It’s really new.
Andrea J. Singer, MD, FACP, CCD: It’s brand new. Its generic name is romosozumab. It is a sclerostin inhibitor.
Peter L. Salgo, MD: It’s a mAb [monoclonal antibody].
Andrea J. Singer, MD, FACP, CCD: It is a mAb, so it’s a monoclonal antibody to sclerostin.
Peter L. Salgo, MD: Got it.
Andrea J. Singer, MD, FACP, CCD: Sclerostin is an osteocyte-derived inhibitor of bone formation, because osteocytes are some of the cells that are important in the bone remodeling process. When sclerostin is present, it inhibits bone formation. If you give an antibody that binds it so that it can’t hit its target endpoints, it is going to increase bone formation and, to a lesser degree, decrease bone resorption. So it’s the first sort of dual action bone-building drug that we have.
Peter L. Salgo, MD: This sounds great. Now tell me what’s wrong with it.
Andrea J. Singer, MD, FACP, CCD: Well, before I tell you what’s wrong with it, I’d rather tell you what’s right with it. I know we’re going to go through some of the data.
Peter L. Salgo, MD: You just did. Tell me more.
Andrea J. Singer, MD, FACP, CCD: It really is an excellent drug when we look at outcomes, both in terms of increases in bone mineral densities, which are significant, as well as decreases in fracture reduction. Everything in life has risk, right? I would hazard a guess to say that there’s very little or nothing in life that’s risk-free. So there are potential risks with this, and to put aside sort of the elephant in the room, it’s major adverse cardiovascular events that have been reported. There was an imbalance. We’re going to talk about some of the clinical trials. There was a robust development program with over 14,000 women studied in 3 major clinical trials. In 1 of the 3 trials, there was an imbalance in cardiovascular events between the group treated with romosozumab compared with the group treated with alendronate. In the other trials, there was no imbalance seen. So we’re talking about a small but potential increased risk, and this is something that we need to discuss with patients.
Peter L. Salgo, MD: How do you give the drug? Is it oral? Is it injected? Is it intravenous? Intramuscular?
Andrea J. Singer, MD, FACP, CCD: It’s a once-a-month subcutaneous injection given in a healthcare provider’s office.
Peter L. Salgo, MD: And you’ve got to watch the patient? Can you give this yourself, or do you have to go to the doctor’s office?
Andrea J. Singer, MD, FACP, CCD: The way it’s labeled, you’re supposed to go to the doctor’s office and be watched briefly after the injection is given. It actually comes in 2 syringes because of the volume, so it’s actually 2 shots at the same time in the healthcare provider’s office.
Peter L. Salgo, MD: It’s a bit more robust than those little diabetes things....
Andrea J. Singer, MD, FACP, CCD: Absolutely, yes.
Peter L. Salgo, MD: Is that why you were chuckling over there?
Thomas P. Olenginski, MD, FACP, CCD: I love your questions, Peter.