Zoledronate (Reclast, Zometa) Reduced Fractures in Older Women with Osteopenia

MedicalResearch.com Interview with:

Prof Ian Reid Faculty of Medical and Health Sciences University of Auckland Auckland New Zealand 

Prof. Reid

Prof Ian Reid
Faculty of Medical and Health Sciences
University of Auckland
Auckland New Zealand 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Bisphosphonates prevent fractures in patients with osteoporosis, but their efficacy in women with less marked bone loss (referred to as osteopenia) is unknown.

Most fractures in postmenopausal women occur in osteopenic patients, so therapies with efficacy in osteopenia are needed.

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Bisphosphonates Can Be Reduced In Second Year of Breast Cancer Metastases

MedicalResearch.com Interview with:

Gabriel N. Hortobagyi, MD, FACP, FASCO Professor, Department of Breast Medical Oncology Division of Cancer Medicine The University of Texas MD Anderson Cancer Center Houston, TX 77230-1439

Dr. Gabriel Hortobagyi

Gabriel N. Hortobagyi, MD, FACP, FASCO
Professor, Department of Breast Medical Oncology
Division of Cancer Medicine
The University of Texas MD Anderson Cancer Center
Houston, TX 77230-1439 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Bisphosphonates have been commercially available for several decades as supportive care for patients with bone metastases. They reduce the frequency and severity of bone-related complications. While the optimal dose and short-term scheduling of zoledronic acid (and previously, pamidronate) have been determined, there has been no research to determine how long these drugs need to be maintained nor the optimal dose and schedule beyond the first year of therapy. These questions are particularly important for this family of drugs, since they are incorporated into bone and not excreted from the body for many years.

We set out to determine whether a reduction in the frequency of administration of zoledronic acid (every 12 weeks) was able to maintain the therapeutic efficacy of this intervention when compared to the “standard” schedule of administration (every 4 weeks). It was a prospective, randomized, non-inferiority trial that recruited patients with metastatic breast cancer with bone metastases and who had previously received 9 or more doses of zoledronic acid or pamidronate. The primary endpoint was the proportion of patients with one or more skeletal-related events. Four hundred and sixteen patients were randomized in a 1:1 ratio. The two groups were comparable at baseline. After the first year of follow-up, there was no statistically significant difference in SRE rate between the two arms, confirming the non-inferiority fo the every-12-week schedule of zoledronic acid.

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Bisphosphonates For Bone Metastases May Be Given Less Frequently

MedicalResearch.com Interview with:

Charles L. Shapiro, MD Professor of Medicine Co-Director of Dubin Breast Center Director of Translational Breast Cancer Research Director of Cancer Survivorship, Tisch Cancer Institute Mount Sinai Health System Division of Hematology / Medical Oncology: Tisch Cancer Institute New York, NY 10029

Dr. Charles Shapiro

Charles L. Shapiro, MD
Professor of Medicine
Co-Director of Dubin Breast Center
Director of Translational Breast Cancer Research
Director of Cancer Survivorship, Tisch Cancer Institute
Mount Sinai Health System
Division of Hematology / Medical Oncology: Tisch Cancer Institute
New York, NY 10029

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Metastases to bone are frequent in many cancers and cause pain, pathological fractures, necessitate surgical and/or radiation treatments, cause spinal chord compression that can lead to paralysis, and significantly increase health care costs.

Zoledronic acid, a bisphosphonate that inhibits bone resorption, is used in standard practice because it reduces the risks skeletal-related events including cancer-related pathological fractures, the need for surgery and/or radiation to bone metastases, and spinal chord compression in patients with breast cancer, prostate cancer and multiple myeloma.

However, the optimal dosing interval for zoledronic acid is unknown and based on prior studies and empiricism it is administered monthly along with anti-cancer treatments.

In this trial, over 1800 breast cancer, prostate cancer and multiple myeloma patients with bone metastases were randomized to the standard dosing interval of monthly zoledronic acid versus every 3-months zoledronic acid for a duration of two years.

The results overall, and in each specific disease site, show that giving zoledronic acid once every 3-months as opposed to monthly did not result in any increase in skeletal-related
events.

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Are Bisphosphonates Underutilized In Men on Androgen Deprivation Therapy?

MedicalResearch.com Interview with:
Shabbir M. H. Alibhai, MD, MSc and
Husayn Gulamhusein, BHSc
Department of Medicine, University Health Network
Toronto, Ontario, Canada

Medical Research: What is the background for this study? What are the main findings?

MedicalResearch: In 2009, we published a research letter in JAMA which examined the rate of bone mineral density (BMD) testing in men starting androgen deprivation therapy (ADT) in the province of Ontario, Canada, between 1995 and 2008. Despite being recommended as a tool to better characterize fracture risk and optimize bone health, use of bone mineral density testing was low throughout the study period. This current study focuses on another aspect of bone health, which is the use of bisphosphonates among men undergoing androgen deprivation therapy for prostate cancer. Bisphosphonates are generally safe and effective medications that can reduce fracture risk particularly in those at higher risk of future fracture. Throughout the 17-year study period, we found that rates of new prescriptions for bisphosphonates remained low. Even when focusing on those men who should be receiving bisphosphonates as per Canadian guidelines due to their high risk for future fracture, i.e. those with a prior fragility fracture or prior diagnosis of osteoporosis, prescription rates remained low. Moreover, in all three groups, new bisphosphonate prescriptions dipped between the 2007-09 and 2010-12 time periods. This may be partly due to recent negative media attention regarding the association of bisphosphonates with rare but serious side effects (i.e. osteonecrosis of the jaw and atypical femoral fracture).
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Bisphosphonates: Risks of AFib and Stroke

Abhishek Sharma, M.B.B.S. Maimonides Medical Center in Brooklyn, N.Y.MedicalResearch.com Interview with:
Abhishek Sharma, M.B.B.S.
Maimonides Medical Center in Brooklyn, N.Y.

 

MedicalResearch.com: What are the main findings of the study?

Answer:  Evidence from RCT’s and observational studies suggests a significantly increased risk of atrial fibrillation (AF) requiring hospitalization, but no increase in risk of stroke or cardiovascular mortality with the use of bisphosphonate. Continue reading