FDA approves Reclast (zoledronic acid) for osteoporosis in postmenopausal women

Jun 1 2009

Reclast (zoledronic acid) Injection has been approved by the US Food and Drug Administration (FDA) as the first and only therapy to prevent postmenopausal osteoporosis for two years with a single dose. Reclast is already approved as a once-yearly infusion for the treatment of postmenopausal osteoporosis.

The FDA decision is based on a study involving more than 500 postmenopausal women with osteopenia, or low bone mass, showing that a single infusion of Reclast significantly increased bone mineral density (BMD) at two years compared to placebo.

Approximately 22 million women in the US have osteopenia, putting them at increased risk of osteoporosis, a disease that causes bones to break more easily. Osteoporosis is a major public health threat affecting an estimated 10 million men and women in the US.

Although low bone mass is less severe in people with osteopenia than those with osteoporosis, they are still at increased risk of fractures. In fact, research shows that approximately half of women who experience a fragility fracture, or a broken bone due to a fall from standing height or less, have osteopenia, highlighting the importance of treating and preventing further bone loss.

"It is very important to treat postmenopausal women with low bone mass to help prevent them from progressing to osteoporosis," said Mone Zaidi, MD, PhD, Professor of Medicine, Geriatrics, and Physiology and Director of the Mount Sinai Bone Program at Mount Sinai School of Medicine in New York, USA. "The dosing of Reclast for the prevention of postmenopausal osteoporosis offers an advance over existing therapies since it can be given once every two years, instead of daily, weekly or monthly."

Reclast is already approved as a once-yearly infusion to treat postmenopausal osteoporosis, to increase bone mass in men with osteoporosis, and to treat and prevent osteoporosis caused by glucocorticoids, commonly known as steroids. Reclast is also approved for the treatment of Paget's disease of bone, the second most common metabolic bone disorder, in men and women.

"We are very pleased that this latest US approval recognizes the large body of safety and efficacy data for Reclast and underlines its potential to protect patients with a number of bone disorders," said Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG. "Women with low bone mass in the US now have an important new option that is proven to strengthen their bones, and therefore help prevent the onset of osteoporosis, for a full two years with only one infusion."

The new indication to prevent bone loss in postmenopausal women with osteopenia was based on a two-year randomized, multi-center, double-blind, placebo-controlled study of 581 postmenopausal women older than 45 years of age. The primary endpoint was the change in BMD at two years relative to baseline.

This study included women in early menopause (i.e. within five years of menopause) and late menopause (i.e. more than five years from menopause). Patients were divided into three groups and received either Reclast at the beginning of the study and again at one year, Reclast at the beginning of the study and placebo at one year, or placebo at the beginning of the study and again at one year.

Reclast significantly increased lumbar spine BMD relative to placebo at the end of the two-year study . Treatment with Reclast given as a single dose at the beginning of the study increased lumbar spine BMD by 6.3% in the early menopause group and by 5.4% in the late menopause group at two years (both p<0.0001).

You should not take Reclast if you're on Zometa (zoledronic acid) Injection because it contains the same active ingredient. Additionally, you should not take Reclast if you have low blood calcium, kidney problems, or are allergic to Reclast. If you are pregnant, plan to become pregnant, or are nursing, you should not take 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. Tell your doctor if you have dental problems because rarely, problems with the jaw have been reported with Reclast. Discuss all medicines you are taking, including prescription and non-prescription drugs, vitamins, and herbal supplements. If you develop severe bone, joint, or muscle pain, numbness, tingling or muscle spasms, contact your doctor.

Aclasta/Reclast has been used in nearly 500,000 patients worldwide, including more than 238,000 in the US, to help prevent fractures. It is available in all 50 US states and reimbursed by all Medicare Part B carriers and virtually all health insurance plans. Reclast can be administered in physicians' offices or at one of more than 5,600 infusion centers located throughout the US.

The active ingredient in Reclast is zoledronic acid 5 mg administered once a year when treating postmenopausal osteoporosis. Reclast contains the same active ingredient found in Zometa (zoledronic acid) Injection.