Experts Speak Out: Once-a-Year Injection for Osteoporosis

May 2, 2007 — -- A new option in the treatment of osteoporosis could one day change the way many of the 10 million Americans living with the bone-weakening condition are treated by doctors.

Research published in the current issue of the New England Journal of Medicine shows that a drug called Zometa (also known as Reclast), which is currently used in the treatment of metastatic bone cancer, also prevents bone loss through osteoporosis.

Patients taking the drug in the trial experienced a 70 percent reduced risk of fractures to the vertebrae, a 41 percent reduced risk of hip fracture and an overall improvement in bone density.

But what really sets the treatment apart from current options is the fact that it's a 15-minute, once-a-year IV procedure — a tempting prospect for many patients who cannot stomach the oral medications that are currently available.

But the treatment may come with risks as well; some of the patients taking the treatment experienced atrial fibrillation — an abnormal, potentially dangerous heart rhythm disorder.

Here's what experts had to say about the possible benefits — and side effects — of this possible future treatment:

Dr. Steven Cummings

Senior Author

Emeritus Professor of Medicine and Epidemiology

University of California at San FranciscoSan Francisco, Calif.

Only about one-third of patients continue to take oral treatments as long as one year. Giving one infusion a year guarantees compliance which, in turn, increases the effectiveness of treatment -- like an airbag instead of seat belts.

Dr. C. Conrad Johnston Jr.

Distinguished Professor of Medicine

Indiana University School of Medicine

Indianapolis, Ind.

This clinical trial of zolendronic acid demonstrates very good reduction in fracture risk with relatively few side effects. Most important, this therapeutic approach could significantly reduce the poor adherence found with oral agents. It is an important addition to our armamentarium to fight osteoporosis.

Dr. Lawrence Raisz

Director

The University of Connecticut Center for Osteoporosis

Hartford, Conn.

The issue of atrial fibrillation is important and will mean the patients need to be warned and monitored.

Dr. Brian William Walsh

Director, Division of Surgical Gynecology

Brigham and Women's Hospital

Boston, Mass.

An excellent study — well designed, adequately powered, showing statistically and clinically significant reductions in fracture rates. [Reclast] is potentially a breakthrough for the treatment of osteoporosis.

Dr. Robert Neer

Director, MGH Osteoporosis Center

Massachusetts General Hospital

Boston, Mass.

Neither the manuscript nor the editorial discuss why atrial fibrillation was more serious, but not more frequent, in zoledronate-treated patients. Was the atrial fibrillation more symptomatic, or accompanied by lower blood pressure or faster ventricular rate in zoledronate-treated patients? If not, in what way was the atrial fibrillation more often "serious"? Unless these data are reported more completely, they cannot be judiciously interpreted.

J. Edward Puzas

Professor of Orthopaedics

University of Rochester School of Medicine and Dentistry

Rochester, N.Y.

Most experts feel that this drug will provide a new approach to treating patients. The ability to administer a medication once a year to patients will increase compliance and ensure that a person gets the appropriate dose.

The data show no serious adverse effects over placebos, but until the medication is in widespread use, it is difficult to tell if there are any problems — just look at the issues with Vioxx.

Dr. Robert R. Recker

Director

Osteoporosis Research Center

Creighton University School of Medicine

Omaha, Neb.

The safety data show a minor concern regarding atrial fibrillation. This is not a major concern, since there was no significant increase in mortality or morbidity. More studies are needed to discover the mechanism of the association. The association could have occurred by chance.

Dr. Roberto Pacifici

Director, Division of Endocrinology, Metabolism and Lipids

Emory University School of Medicine

Atlanta, Ga.

This is a remarkable study, as it transforms osteoporosis in a disease that can be prevented and treated with a once-a-year intervention (almost an immunization against osteoporosis). The convenience factor is a terrific benefit!

Patients demand convenience and efficacy. It will become dominant in the marketplace.

Dr. John L. Abruzzo

Professor of Medicine, Division of Rheumatology

Thomas Jefferson University

Philadelphia, Pa.

A condition known as osteonecrosis of the jaw has drawn great public attention and has been primarily associated with Zometa when used in the treatment of malignant diseases in conjunction with chemotherapies and a compromised immune system. Osteonecrosis of the jaw did not appear to be an issue in the clinical trial.

Perhaps exposure to the drug was not long enough (three years). Or perhaps, osteonecrosis of the jaw is, for all intents and purposes, a nonissue for the overwhelming majority of individuals being treated for osteoporosis with a bisphosphonate, including zoledronic acid.

Dr. Edward S. Leib

Director, Osteoporosis Center

Fletcher Allen Health Care

Burlington, Vt.

Although there is not a clear reason why there is an increase in cardiac findings, especially atrial fibrillation, this is of concern and may require more evaluation, including animal studies of cardiac toxicity. This might affect the FDA's interest in approving this for therapy.

Dr. Donna Shoupe

Professor of Obstetrics and Gynecology

Keck School of Medicine at the University of Southern California

Los Angeles, Calif.

I have reviewed the data on Zolendronic acid and am very favorably impressed. There will be very appropriate patients that will benefit from this therapy. It is very effective medication.

I think the biggest challenge is getting insurance coverage for the physicians that will be giving it in the office and making it cost effective.

Dr. Robert Yood

Chief of Rheumatology

Fallon Clinic

Worcester, Mass.

Compliance with oral bisphosphonates is poor; several studies show that by the end of one year, about half of patients have discontinued oral bisphosphonates. If compliance with yearly IV therapy is better, perhaps this drug will overall be more effective.

Dr. Susan Bukata

Assistant Professor of Orthopaedics

University of Rochester

Rochester, N.Y.

This drug will be a huge help in caring for individuals with memory loss, who just cannot remember to take their medications, for individuals who may not be absorbing the oral pills as efficiently as we would like, despite good compliance, and for individuals who have upper GI symptoms, including heartburn/reflux from the oral pills. It will most definitely help compliance, because it will also likely be tied into a doctor's visit.

Dr. Javad Parvizi

Joint Specialist and Director of Orthopaedic Research

Rothman Institute at Thomas Jefferson University Hospital

Philadelphia, Pa.

I don't think we should anticipate FDA regulations, but if approved, the use of this medication should be reserved to a limited population without heart conditions and severe or refractory osteoporosis.