Pharmacotherapy of osteoporosis 1

Published on August 31, 2015   37 min
0:00
Hello. I'm Dr. Michael McClung, the director of the Oregon Osteoporosis Center in Portland, Oregon. I'm very happy to be a part of this Henry Stewart Talk series entitled bone in health and disease. The series editor, Professor Compston, has asked me to address the topic of pharmacotherapy of osteoporosis.
0:23
On the next slide are listed my current financial disclosures. I have relationships with several of the drug companies that make the drugs that we'll be discussing today. Over the past 20 years, I and my center have been involved with clinical studies with virtually all of the drugs that are approved for osteoporosis, and at least in that context, have had a financial relationship with those companies.
0:50
In previous parts of this series, the definition of osteoporosis has been described. It is a disorder that is due to bone loss that results in a damage to the architecture of the skeleton, resulting in a weakening of the skeleton and an increased risk of fracture. The objectives of pharmacotherapy are twofold. The primary objective is to protect the patient from fracture, and to reduce the risk of fractures by strengthening the skeleton. There are patients who are not at high risk for fracture, but who are about to experienced rapid bone loss. And there are instances when some drugs are used for a short time to prevent the rapid bone loss that may be occurring in certain patients. And we'll talk about that a little later in the presentation.
1:42
In this presentation, I will discuss the drugs that are currently approved in the United States or in Europe. I will not discuss calcium or other minerals, vitamin D metabolites or vitamin K, the effect of tibolone, phytoestrogens, or herbal preparations. I will also not discuss the treatment of osteoporosis in men or in patients receiving glucocorticoids, and I will only briefly mention combining osteoporosis therapies. Many of those topics will be discussed in subsequent versions and chapters of this online course.
2:21
In this busy slide, I have listed all of the drugs that are currently approved by either the FDA or the EMA for osteoporosis management as of the current date. I have grouped the drugs by mechanisms of action and by class type. And you can see that there are some 15 drugs that are approved. There are differences in the approval between the European and the American agencies. The reasons for those differences are individualized for each of the drugs. Some of the drugs have not been brought to the attention of the FDA for consideration of approval. Others have been brought before both the FDA and the EMA, and for various reasons, one or the other agency chose not to approve a drug. And in the case of salmon calcitonin, this drug was previously approved by the EMA, but in the last two years, because of issues we will discuss, that drug is no longer approved for treating osteoporosis in Europe.
3:31
Understanding the regulatory rules and mechanisms for approval of drugs for osteoporosis is important. I've focused here on the indications and the mechanisms by which drugs are approved for osteoporosis management in the United States. For the treatment of postmenopausal osteoporosis, documentation of fracture risk reduction in patients with osteoporosis is required. No surrogate endpoint like changes in bone density or changes in bone turnover are sufficient to satisfy the regulatory requirement. Once a drug has been documented to reduce fracture risk in patients with osteoporosis, the drug can be approved for preventing bone loss and preventing osteoporosis if studies are performed documenting that bone mass is preserved in patients who do not have osteoporosis. Importantly, the prevention indication is not allowed in the European regulatory agency. Again, once a drug has been approved for treating postmenopausal osteoporosis, the drug can be approved for treating men with osteoporosis if the bone density response in a group of men with osteoporosis is similar to that that was observed in the postmenopausal women study. Likewise, drugs can be approved for the management of glucocorticoid induced osteoporosis if the bone density response in those patients is similar to what was observed in the fracture reduction trials. In the United States, there is a difference between treating glucocorticoid induced osteoporosis. Patients have to have been on glucocorticoids for at least a year before they are considered to be worthy of treatment. There is also an indication for prevention of glucocorticoid induced osteoporosis for patients who have recently begun glucocorticoid therapy.
Hide

Pharmacotherapy of osteoporosis 1

Embed in course/own notes