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FDA Broadens Indication for Zoledronic Acid to Include Prevention of New Clinical Fractures

EAST HANOVER, N.J., June 5 /PRNewswire/ -- The US Food and Drug Administration (FDA) has broadened the US indication for once-yearly Reclast(R) (zoledronic acid) Injection to include the prevention of new clinical fractures in patients who have recently had a low-trauma hip fracture.

No other osteoporosis treatment has demonstrated a reduction of new clinical fractures in patients who have recently had a low-trauma hip fracture (e.g., due to a fall from standing height or less). A clinical fracture is defined as a composite endpoint of skeletal sites excluding finger, face and toe.

The FDA decision is based on safety and efficacy data from the landmark Recurrent Fracture Trial, published in The New England Journal of Medicine, showing a significant 35% reduction in the risk of new clinical fractures in patients treated with Reclast.

"The consequences of osteoporosis can be devastating, particularly hip fractures. However, few patients actually receive treatment for the prevention of additional fractures after a hip fracture," said Kenneth G. Saag, MD, MSc, Professor of Medicine and Epidemiology, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham. "In the first large scale clinical trial of its kind, these data support an efficacious therapeutic option for patients after a hip fracture."

Osteoporosis is a condition in which the bones become weak and can break more easily. Around 10 million people in the US are affected by osteoporosis, which caused an estimated 297,000 hip fractures in the US in 2005. Of those patients who experience a hip fracture, almost a quarter of people over the age of 50 die from complications within one year.

Among those who experience a hip fracture, 85% need help walking at six months, nearly 20% who could walk before their hip fracture require long-term nursing care, and all remain at high risk of further fracture. Yet, currently few patients are treated for osteoporosis following a hip fracture.

The Recurrent Fracture Trial involved more than 2,100 men and women aged 50 and older with osteoporosis who had experienced a recent low-trauma hip fracture. Results showed that Reclast increased bone mineral density (BMD) and reduced the risk of new clinical fractures by 35% compared to patients treated with placebo. The risk of new spine fractures was reduced by 46%. The incidence of all-cause mortality was 9.6% in the Reclast group and 13.3% in the placebo group.

The updated US label further reinforces the safety and efficacy of Reclast, the only once-yearly treatment for postmenopausal osteoporosis approved in the US and European Union (EU) (under the name Aclasta(R)) for the reduction in the incidence of fractures in all key areas of the body typically affected by this disease, including the hip, spine and non-spine. Regulatory approval is also being sought for Aclasta in the EU for this broadened indication.

Reclast is given as a once-yearly 15-minute intravenous infusion(1). This means a single treatment, along with daily calcium and vitamin D supplements, helps protect against fracture for a full year.

"The new label reinforces the potential of Reclast for treating a range of osteoporosis patients," said Trevor Mundel, MD, Head of Global Development Functions at Novartis Pharma AG. "These data support the clear need to treat patients after hip fracture who are at risk of the potentially devastating and life-threatening consequences of osteoporosis."

Reclast is already approved in more than 50 countries for the treatment of postmenopausal osteoporosis and in more than 70 countries for the treatment of Paget's disease of bone, the second most common metabolic bone disorder.

The active ingredient in Reclast is zoledronic acid 5 mg administered once a year. Zoledronic acid is also available in a different dosage under the brand name Zometa(R) (zoledronic acid) Injection 4 mg administered every three to four weeks in certain oncologic indications.

Patients should not take Reclast if they're on Zometa as it contains the same ingredient; if they have low blood calcium, kidney problems, or are allergic to Reclast or Zometa; or they're pregnant, plan to become pregnant or nursing.

It's important for patients to drink fluids before getting Reclast to help prevent kidney problems. The most common side effects are flu-like symptoms, fever, muscle or joint pain and headache. Patients should tell their doctor if they have dental problems because rarely, problems with the jaw have been reported with Reclast. Patients should tell their doctor if they have low blood calcium or cannot take calcium and vitamin D, had surgery involving the neck or intestines. In patients with Paget's disease of bone, it is especially important for them to take 1500 mg of calcium and 800 IU of vitamin D daily, particularly during the first 2 weeks after getting Reclast. Patients should discuss all medicines they're taking, including prescription and non-prescription, vitamins and herbal supplements. Patients should contact their doctor if they develop severe bone, joint or muscle pain, numbness, tingling or muscle spasms.

For more information about Reclast, visit or call 866-RECLAST (866-732-5278).

Source: Novartis

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