In Honor of World Osteoporosis Day
FDA approves Reclast ® to prevent osteoporosis in postmenopausal women with convenient less frequent dosing.
Single infusion of Reclast increases bone mass for two years in postmenopausal women with osteopenia, a condition that can lead to osteoporosis.
Approximately 22 million women in US have osteopenia, or low bone mass, putting them at increased risk of fractures of hip, spine and wrist.
Reclast already approved as once-yearly infusion for treatment of postmenopausal osteoporosis (Novartis Press Release 2009).
To help us understand the implications, risks and benefits of this new drug approval Dr. Kathryn Diemer has graciously agreed to answer my questions about this new application of Reclast for the treatment of osteopenia. Dr. Diemer’s biography is below explaining her expertise in this area and her involvement in this field of study.
Dr. Diemer’s Bio:
Dr. Diemer was born and raised in St. Louis, Mo. She attended the University of Missouri -Kansas City, which is a six-year, combined BA-MD program. She graduated with Honors with a BA in biology and her Medical degree in 1985. She served her internship in obstetrics and gynecology at Truman Medical Center in Kansas City before returning to St. Louis. In 1986, Dr. Diemer began her residency training in internal medicine at the Jewish Hospital of St. Louis at Washington University School of Medicine. She served as chief resident in internal medicine in 1989. In 1990, she began work with Dr. Louis Avioli who was chief of the Division of Bone and Mineral Metabolism at Washington University School of Medicine. She has been a faculty member and attending physician in the Bone Health Program since 1990. Dr. Diemer presently serves as the clinical director of the Bone Health Program seeing patients with osteoporosis and other metabolic bone diseases. She is actively involved in the education of the Washington University housestaff, fellows, faculty and medical students on the subject of osteoporosis and bone densitometry. She is a certified bone densitometrist and is a faculty member for the International Society of Clinical Densitometry. She has lectured both nationally and internationally on the subjects of osteoporosis and bone densitometry. In recognition of her excellence in patient care, Dr. Diemer was recently named in the St. Louis Magazine as one of St. Louis’ 100 Best Doctors.
Dr. Diemer is also involved with medical education. She served as the associate program director of the Internal Medicine Residency Program at the Jewish Hospital of St. Louis from 1992 - 1995. When Barnes and Jewish Hospitals merged their residency programs, Dr. Diemer was involved with the development of the Primary Care Residency Program and served as the associate program director from 1995 - 1999. She presently is the assistant dean of career counseling at Washington University School of Medicine where she writes the Dean’s letters and counsels the fourth-year medical students on residency training.
Welcome Dr. Diemer Let me thank you on behalf of our readers at Health Central’s OsteoporosisConnection.com. We all look forward to hearing more about this new application, recently approved by the FDA for the treatment of postmenopausal osteopenia.
1. Dr. Diemer I know many of our readers may not fully understand how Reclast works on bone loss and osteoporosis, could you explain it to us?
Reclast is an antiresorptive agent which means it inhibits the osteoclasts - the cells that break down bone - to allow the osteoblasts - the cells that build bone - to rebuild bone.
2. Could you explain the new biennial Reclast treatment to our readers, and how it differs from the once yearly dose of Reclast that is already in use?
Reclast has been approved for prevention of osteoporosis - so those women who do not have osteoporosis yet - can receive a dose every two years - which allows them to maintain their present bone density.
3. Is the biennial dose strength the same as the once yearly dose of Reclast? If they are different, do you expect to see differing types or lengths of side effects?
The milligram dosing is the same, so with the first dose, the possible side effects will be similar.
4. Do you use this biennial dose in your practice and what have your results been?
We have given the first dose - at this point, we haven’t had two years to see the results but the patients have done well with the dosing with minimal side effects.
5. What are the normal side effects, of the biennial Reclast, and how long would you expect them to last?
The most common side effects are a low grade fever and muscles aches - almost a flu-like syndrome. On average it last 24 - 48 hours. About 10% of patients had these symptoms. In subsequent studies, taking acetaminophen or ibuprofen decreased the side effects down to 5%.
6. Does Reclast cause or exacerbate heart conditions like atrial fibrillation or other types of heart disease? I’m not sure I totally understand the FDA warning on this and it’s subsequent retraction or rewording.
In the pivotal clinical trial looking at Reclast for treatment of osteoporosis, there was a slightly higher (but significant) number of patients who developed atrial fibrillation compared to placebo in the first year. It did not happen in subsequent years. Multiple studies since that one have been done and the atrial fibrillation did not occur. The FDA reviewed all the follow up data and concluded that it is not a risk.
7. I know a lot of our readers are very concerned with the prospects of contracting osteonecrosis of the jaw, and we actually have some members currently dealing with this; what can you tell them about the likelihood of developing this problem from IV Reclast?
In the Reclast trials there was no difference in terms of development of osteonecrosis of the jaw compared to placebo. The majority of patients who have developed osteonecrosis were cancer patients receiving higher doses. There are risk factors for developing ONJ: cancer, radiation therapy, diabetes, periodontal disease. Any patients who are considering treatment with any of the bisphosphonates, should have any dental issues resolved prior to treatment. I would not consider any of those conditions absolute contraindications to using Reclast - again, patients with dental disease should have that resolved before using it.
8. Do we know how long Reclast remains in the body; is there a test that will answer this question?
There are tests that can be done called markers of bone turnover which can show the effect Reclast has on the bone, In those studies, it showed that the major effects occurred at three months after the infusion, the markers gradually returned to baseline by the end of the year.
9. Do bisphosphonates cause brittle or weakly structured bone, like some studies claim, where we see very unusual types of bone fractures that are not common in those not taking these drugs?
There have been clinical reports of patients developing subtrochanteric hip fractures (a lower site than where hip fractures usually occur) after long term use of bisphosphonates - in a study we recently published, it was after six or more years of treatment - so we often recommend stopping at five years. In long term Fosamax trials, however, they showed normal bone after ten years of use - so the data is conflicting.
10. Some Doctors don’t recommend treating osteopenia with a bisphosphonate, especially an infused dose, what is your opinion on this and why?
Until the Reclast trial on use in osteopenia, the data was very limited on treatment for osteopenic women, so I think that was why some physicians were reluctant to use them. I think it becomes a very individual decision with each patient - not just looking at bone density but looking at other risk factors for fracture. I always say, we are not treating a T-score, we are treating a patient and we need to look at the whole picture.
11. If a patient already has some form of chronic joint or muscle pain, would you suggest this type of treatment, since it’s listed as a possible side effect?
Yes, the muscle pain is really limited on most patients to twenty four to forty eight hours although a few lasted up to twelve days, but it is self limited.
12. What is the most promising and exciting information that you’ve obtained from the clinical trial done on this new drug application of biennial Reclast for osteopenia?
It gives us another option for treatment that is well tolerated and convenient for the patients - usually younger, busy women. It also becomes very cost effective with the biannual dosing.
Thank you once again Dr. Diemer for your imformative interview.
Important Safety Information
Patients should not take Reclast if they’re on Zometa ® (zoledronic acid) Injection because it contains the same active ingredient. Additionally, patients should not take Reclast if they are pregnant, plan to become pregnant, are nursing, have low blood calcium, kidney problems, or are allergic to Reclast.
It’s important to drink fluids before getting Reclast to help prevent kidney problems. The most common side effects include flu-like symptoms, fever, muscle or joint pain, headache, nausea, vomiting, and diarrhea. Patients should tell their doctor if they have dental problems because rarely, problems with the jaw have been reported with Reclast. Patients should discuss all medicines they’re taking, including prescription and non-prescription drugs, vitamins, and herbal supplements. Patients should contact their doctor if they develop severe bone, joint, or muscle pain, numbness, tingling or muscle spasms. (Novartis 2009)