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Study Shows Once-Monthly Ibandronate Increases Bone Density, Reduces Bone Breakdown

SEATTLE, Oct. 4 /PRNewswire-FirstCall/ -- The bisphosphonate Boniva™ (ibandronate sodium), taken orally in an investigational, once-monthly regimen, was at least equivalent to the previously approved once-daily oral Boniva in increasing spine and hip bone mineral density (BMD)(1,2), and reducing bone resorption (bone breakdown)(3) and was generally well tolerated(4), according to study findings reported at the 26th Annual Meeting of the American Society for Bone Mineral Research (ASBMR).

"These findings are important because they show that Boniva has potential for once-monthly oral dosing, which may provide a more convenient treatment option for many women with postmenopausal osteoporosis," said lead investigator Robert Recker, M.D., Chief of Endocrinology and Director of the Osteoporosis Research Center at the Creighton University School of Medicine in Omaha, Neb. "Less frequent dosing may be less disruptive to patients' morning routines and help them stay on therapy, which is critical since osteoporosis is a chronic disease that requires patients to take medication as prescribed over the long-term to derive the most benefit," he said.

The U.S. Food and Drug Administration (FDA) approved a once-daily oral formulation of Boniva in May 2003. Roche and GlaxoSmithKline, which are co-developing the drug, are not marketing the daily dose but have been exploring less frequent dosing regimens before launching the product. A supplemental new drug application (sNDA) for a once-monthly dosing formulation of Boniva was submitted to the FDA in May 2004 for the treatment and prevention of postmenopausal osteoporosis.

Study Findings

The findings were based on data from MOBILE (Monthly Oral iBandronate In LadiEs), a two-year, randomized, double-blind trial comparing the efficacy and safety of monthly oral doses of Boniva (100 mg or 150 mg) versus the FDA-approved oral daily regimen (2.5 mg) in 1,609 women with postmenopausal osteoporosis (lumbar spine BMD T-score less than -2.5 and greater than or equal to -5). During four separate presentations at the ASBMR Annual Meeting, researchers provided one-year results from MOBILE showing that:

* Monthly and daily Boniva reduced bone resorption (as measured by serum CTX) to normal premenopausal levels within three months of initiation, and maintained this suppression with continued therapy(3). Women taking monthly Boniva had at least an equal reduction in bone resorption(2), compared to women who received daily Boniva(2,3). * A greater proportion of women in the 150 mg/month group achieved pre-defined reductions (greater than 30 percent, 50 percent and 70 percent below baseline levels) in bone resorption (as measured by serum CTX) compared to those in the daily dose group(2). * Women taking monthly Boniva had at least an equal increase in BMD of the lumbar spine and hip compared to women who received daily Boniva; those taking the 150 mg/month dose had the greatest increase in BMD(1,2). Further, a greater proportion of women in the 100 mg and 150 mg per month groups achieved increases above baseline in lumbar spine and total hip BMD after one year compared to those in the daily dose group(2). * The once-monthly dosing was generally well tolerated and similar to daily dosing in terms of adverse effects(4). In the MOBILE study, the most commonly reported adverse events were hypertension, dyspepsia and nausea with daily dosing, and hypertension, dyspepsia and arthralgia with monthly dosing. About Boniva

Boniva (2.5 mg once-daily) is indicated for the treatment and prevention of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, Boniva increases bone mineral density and reduces the incidence of vertebral fractures. Boniva also may be considered for postmenopausal women who are at risk for developing osteoporosis and for whom the desired clinical outcome is to maintain bone mass and reduce the risk of vertebral fracture.

Boniva is contraindicated in patients unable to stand or sit upright for at least 60 minutes, patients with hypersensitivity to any component of this product, and patients with uncorrected hypocalcemia. Boniva, like other bisphosphonates administered orally, may cause upper gastrointestinal disorders such as dysphagia, esophagitis and esophageal or gastric ulcer.

Complete prescribing information is available through Roche and GSK. Boniva 2.5 mg once-daily is approved, but is not marketed.

About Osteoporosis

Osteoporosis (porous bones) is a disease in which bones become brittle and more likely to break. Common and chronic conditions, osteoporosis and low bone mass (osteopenia) pose a major public health threat to more than 44 million Americans over age 50(5). In the U.S. today, ten million individuals, eight million of whom are women, are estimated to already have osteoporosis, and almost 34 million more are estimated to have osteopenia, placing them at increased risk for osteoporosis(5). Unfortunately, the prevalence of osteoporosis is growing, especially as the number of postmenopausal women in the population continues to rise. An estimated 52 million women and men age fifty plus are expected to be affected by osteoporosis and osteopenia by 2010 and 61 million are expected to be affected by 2020(5).

About the Roche/GSK Collaboration

In December 2001, Roche and GSK announced that they would co-develop and co-promote Boniva for the treatment and prevention of postmenopausal osteoporosis in all countries, except Japan. The Roche/GSK collaboration provides expertise and commitment to bring new osteoporosis therapies to market as quickly as possible.

References: (1) Miller PD, Drezner MK, Delmas PD, Stakkestad JA, Hughes C, Bonvoisin B, Reginster J-Y. Monthly oral ibandronate is at least as effective as oral daily ibandronate in postmenopausal osteoporosis: 1-year results from MOBILE. Poster F408 presented at: 26th Annual Meeting of the American Society for Bone Mineral Research, October 1-5, 2004, Seattle, WA. (2) Emkey R, Felsenberg D, Stepan JJ, Hughes C, Dumont E, Van der Auwera P, Recker RR. Once monthly dosing increases the proportion of patients who respond to oral ibandronate: 1-year results from MOBILE. Poster M432 presented at: 26th Annual Meeting of the American Society for Bone Mineral Research, October 1-5, 2004, Seattle, WA. (3) Recker RR, Kendler DL, Adami S, Hughes C, Dumont E, Schimmer RC, Cooper C. Monthly oral ibandronate significantly reduces bone resorption in postmenopausal osteoporosis: 1-year results from MOBILE. Poster SA406, presented at: 26th Annual Meeting of the American Society for Bone Mineral Research, October 1-5, 2004, Seattle, WA. (4) Lewiecki EM, Miller PD, Lorenc R, Hughes C, Bonvoisin B, McClung MR. Monthly oral ibandronate is well tolerated in women with postmenopausal osteoporosis: 1-year results from MOBILE. Poster M429, presented at: 26th Annual Meeting of the American Society for Bone Mineral Research, October 1-5, 2004, Seattle, WA. (5) America's Bone Health: The State of Osteoporosis and Low Bone Mass in Our Nation. The National Osteoporosis Foundation. February 2002.

Source: Roche; GlaxoSmithKline

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