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FDA Approves Boniva Injection as First IV for Postmenopausal Osteoporosis

New quarterly medicine is unique alternative for treatment of osteoporosis

Jan. 7, 2006 – Postmenopausal women will now have a new weapon in the battle against osteoporosis. The FDA has approved Boniva (ibandronate sodium) Injection as the first intravenous medication for the treatment of postmenopausal osteoporosis, Roche and GlaxoSmithKline (GSK) announced yesterday. It is to be administered by a healthcare professional once every three months.

Boniva Injection, also the first quarterly medication for the treatment of postmenopausal osteoporosis, is a member of the bisphosphonate class, which is the most frequently prescribed medicine for osteoporosis.

Osteoporosis leads to 1.5 million fractures, or breaks, per year, mostly in the hip, spine and wrist, with the cost of treatment estimated at $17 billion and rising, according to the National Institutes of Health (NIH).

It threatens 34 million Americans, mostly older women, but older men get it too. One in 2 women and 1 in 4 men older than 50 will suffer a vertebral fracture, according to the NIH. These numbers are predicted to rise as the population ages.

"Boniva Injection is a truly novel osteoporosis therapy. It represents an important new opportunity to bring the bone-strengthening benefits of Boniva to more women -- including those who have difficulty with dosing requirements of oral bisphosphonates," said Robert R. Recker, M.D., M.A.C.P., F.A.C.E., Director, Creighton University Osteoporosis Research Center, Omaha, Neb., an investigator in Boniva clinical trials and a leading expert in osteoporosis.

Boniva Injection, administered as a 15-30 second IV injection, will provide an alternative for patients who have difficulty with oral bisphosphonate dosing requirements, including an inability to sit upright for 30 to 60 minutes and/or swallow a pill.

Additionally, because Boniva Injection will be administered by healthcare professionals, clinicians will have a greater awareness of patient compliance with therapy.

The FDA approved once-monthly Boniva tablets in March 2005 as the first once-a-month tablet for postmenopausal osteoporosis. The once-monthly tablet (150 mg) became available in April 2005.

Boniva Injection was approved by the FDA based on results of the DIVA study (Dosing IntraVenous Administration), a clinical trial in 1,358 women with postmenopausal osteoporosis. Boniva Injection will be available early this year.

Approval of Boniva Injection and once-monthly oral Boniva follow a Surgeon General's Report that elevated osteoporosis to a major public health threat on par with smoking and obesity. Forty-four million Americans over 50 years of age are affected by or at risk for osteoporosis, a disease that causes bones to become weak and more likely to break, and can result in severe pain, deformity, disability, hospitalization and even death.

"Osteoporosis is a serious, widespread and growing public health threat. We welcome any new treatment options such as Boniva Injection that will help patients address this all too prevalent disease," said Judith Cranford, Executive Director, National Osteoporosis Foundation.

Clinical Trial Results

Boniva was first approved in a daily oral tablet formulation (2.5 mg) for the treatment and prevention of postmenopausal osteoporosis based on studies showing it significantly reduced the risk of new vertebral fractures in women with postmenopausal osteoporosis and increased bone mineral density (BMD) in postmenopausal women without osteoporosis.

Boniva Injection (3 mg once every three months) was approved based on results from the DIVA study, a randomized, double-blind, multinational, non-inferiority trial in 1,358 women with postmenopausal osteoporosis who were treated with either an IV injection or the once-daily oral formulation of Boniva. All patients received supplemental calcium and vitamin D throughout the trial.

DIVA showed that the average increase in lumbar spine BMD at one year in patients treated with Boniva Injection (3 mg once every three months) was statistically superior to that in patients treated with the daily oral tablets (4.5 percent vs. 3.5 percent for the two treatments, respectively, p < 0.001). The study also showed that patients treated with Boniva Injection had consistently higher BMD increases in the total hip and other skeletal sites (femoral neck and trochanter) than patients treated with oral daily Boniva.(5)

Important Safety Information - Boniva Injection

Boniva Injection is indicated for the treatment of osteoporosis in postmenopausal women. Boniva is contraindicated in patients with uncorrected hypocalcemia or known hypersensitivity to Boniva or any of its excipients. Boniva Injection, like other bisphosphonates administered intravenously, may cause a transient decrease in serum calcium values.

Hypocalcemia, hypovitaminosis D and other disturbances of bone and mineral metabolism must be effectively treated before starting therapy. Patients must receive supplemental calcium and vitamin D. Boniva must only be administered intravenously by a healthcare professional.

Patients who receive Boniva Injection should have serum creatinine measured prior to each dose. Boniva Injection should not be administered to patients with severe renal impairment (creatinine clearance <30 mL/min). Osteonecrosis of the jaw has rarely been reported in patients treated with bisphosphonates; most cases have been in cancer patients undergoing dental procedures who received intravenous bisphosphonates.

In a one-year study comparing Boniva Injection and Boniva Tablets 2.5 mg daily, the overall safety and tolerability profiles with the two dosing regimens were similar. The most commonly reported adverse events (5 percent or higher) regardless of causality were arthralgia (9.6 percent Boniva Injection vs 8.6 percent Boniva Tablet 2.5 mg), back pain (7.0 percent vs. 7.5 percent), influenza (4.7 percent vs. 8.0 percent), hypertension (5.3 percent vs. 7.1 percent), abdominal pain (5.1 percent vs. 5.6 percent), and nasopharyngitis (3.4 percent vs. 6.0 percent). In some patients, acute phase reaction-like events have been reported, usually only after the first injection. In most cases, no specific treatment was required and symptoms subsided in 24-48 hours.

Boniva Tablets

Boniva Tablets is contraindicated in patients unable to stand or sit upright for at least 60 minutes, with uncorrected hypocalcemia, or with known hypersensitivity to Boniva or any of its excipients. Boniva, like other bisphosphonates administered orally, may cause upper gastrointestinal disorders such as dysphagia, esophagitis, and esophageal or gastric ulcer. Boniva is not recommended in patients with severe renal impairment. Adequate intake of calcium and Vitamin D is important in all patients.

Rarely, patients have reported severe bone, joint and/or muscle pain after taking bisphosphonate therapy for osteoporosis. Additionally, osteonecrosis of the jaw has rarely been reported in patients treated with bisphosphonates; most cases have been in cancer patients undergoing dental procedures.

The most commonly reported adverse events with once-monthly Boniva regardless of causality were abdominal pain (Boniva 150 mg 7.8 percent vs. Boniva 2.5 mg 5.3 percent), hypertension (6.3 percent vs. 7.3 percent), dyspepsia (5.6 percent vs. 7.1 percent), arthralgia (5.6 percent vs. 3.5 percent), nausea (5.1 percent vs. 4.8 percent) and diarrhea (5.1 percent vs. 4.1 percent).

For complete prescribing information for Boniva, see contact information at the end of the news release.

About Boniva

Boniva Injection 3 mg/3 mL will be available in boxes containing one single-use, clear glass prefilled syringe, along with one needle and an alcohol swab.

Once-monthly oral Boniva is a small, film-coated, easy-to-swallow tablet dosed at 150 mg. Boniva is also available in an oral 2.5 mg tablet taken once daily.

(See consumer information on the tablets from the FDA below news story.)

About Osteoporosis

Osteoporosis (literally "porous bones") is a disease in which bones become brittle and more likely to break. In the U.S., approximately ten million individuals, eight million of whom are women, are estimated to already have osteoporosis, and almost 34 million more are estimated to have low bone mass (osteopenia), placing them at increased risk for osteoporosis. Unfortunately, the prevalence of osteoporosis is growing, especially as the number of postmenopausal women in the population continues to rise. Together, osteoporosis and osteopenia are expected to affect an estimated 52 million women and men age 50 and older by 2010, and 61 million by 2020. Direct medical costs of osteoporosis total nearly $18 billion in the U.S. each year.

Roche and GSK Collaboration

In December 2001, F. Hoffmann-La Roche (Roche) and GlaxoSmithKline (GSK) announced their plans to co-promote Boniva for the treatment and prevention of postmenopausal osteoporosis in all countries except Japan. The Roche and GSK collaboration provides expertise and commitment to bringing new osteoporosis therapies to market as quickly as possible.

About Roche

Roche is one of the world's leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai. For further information, visit http://www.rocheusa.com/.

About GSK

GSK, one of the world's leading research-based pharmaceutical and healthcare companies, is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit GSK on the World Wide Web at http://www.gsk.com/.

FDA Consumer Information on Ibandronate Sodium (marketed as Boniva)

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