Copyright © 2012
Oregon Osteoporosis Center
All rights reserved
Clinical Research at the O.O.C.
One of the central activities at the Oregon Osteoporosis
Center has been the evaluation of new therapies and diagnostic tools for osteoporosis
and other forms of metabolic bone disease.
Through our research, we have helped generate answers to important clinical questions, and translate those answers into practice management strategies for specialists and primary care providers as well as apply the results to patients in our own clinic.
To learn more about clinical research studies, scroll down or choose from the links below.
Preclinical trials study the effects, mechanism
of action, and drug metabolism in animal models and in basic laboratory research
Phase I studies evaluate the overall safety and metabolism in healthy human subjects.
Phase II studies determine the most appropriate dose by testing several doses in patients with the clinical problem to be treated.
Phase III studies are large, detailed trials carefully documenting the effectiveness, tolerability, and safety of the optimal dose in patients with the clinical problem to be treated.
Phase IV studies are special studies to evaluate the effect in other groups of patients (children, older adults, other diseases, etc.) or to answer interesting or important clinical questions such as the effects of treatment withdrawal, different dosing regimens, or combination therapies.
These studies are almost always funded by the pharmaceutical companies. They are required to submit to the FDA for drug approval, under whose watch they are carefully overseen and regulated. Additionally, studies must conform to international standards of good clinical research practices, and must be frequently reviewed and approved by a local institutional review board.
Only one in about 5000 drugs that enters clinical development ultimately winds its way through the clinical research process. Depending upon the time required for the Phase III studies, it may take from a few to many years of study between the time a drug enters clinical development and the time it becomes available for routine clinical use.
Approval of an estrogen-like drug for the prevention of osteoporosis requires the demonstration that the therapy prevents bone loss, for at least 2 years, in a group of postmenopausal women who do not yet have osteoporosis. Before a drug is approved for treating osteoporosis, it must be shown to reduce the risk of fractures in women who already have osteoporosis. Four to five years are usually required to evaluate new drugs for osteoporosis prevention, while drugs approved for treatment of established osteoporosis have been evaluated for a minimum of 6 years in clinical trials involving thousands of patients. The average cost of the full set of clinical trials needed for FDA approval of an osteoporosis treatment is about $100 million.
Benefits of Participating in Clinical Trials
There are many advantages to being a participant in a clinical research study. The two major reasons for participating in a clinical study are to help yourself and to help others. The specific benefits to patients taking part in clinical trials at the O.O.C. fall into the following categories:
1. Education about osteoporosis, its risk factors,
and treatment options.
2. Regular monitoring of skeletal health and general medical status. Early identification of new health problems.
3. Providing routine test results to your primary care provider.
4. Access to new medications before they become generally available.
5. Study medication and diagnostic tests are free.
6. Interaction with a friendly, knowledgeable, and experienced research team that is concerned about you and your health care needs.
7. Satisfaction from being part of a research project with the goals of adding to scientific knowledge and helping other patients.
Copyright ©2012 Oregon Osteoporosis Center. All rights reserved.