Squabble over bisphosphonate osteoporosis marketing claims

Zosia Chustecka

January 06, 2006

Jan 6, 2006

Bath, UK - A lawsuit alleging false and misleading advertising claims about the new osteoporosis drug ibandronate (Boniva) has been filed by a competitor, the marketers of risedronate (Actonel).

Risedronate is marketed by Proctor & Gamble and Sanofi-Aventis, and these companies together are suing the two companies that market ibandronate, Roche and GlaxoSmithKline. Both drugs are licensed for use in the prevention and treatment of osteoporosis in postmenopausal women, but risedronate, a market leader in this field, has been available for a number of years, as has one other bisphosphonate product, alendronate (Fosamax, Merck & Co). Ibandronate is the newcomer, having been launched in the US only last year. It also has the novelty of being a once-monthly formulation, whereas the other two older products are once-weekly formulations. Although all these drugs are also available as daily oral doses, the reduced frequency of dosing of the newer formulations is a great advantage for these products, which have notoriously low compliance.

Since its launch in the US in April 2005, ibandronate has been heavily promoted in marketing campaigns aimed at both physicians and consumers. The competitor is objecting to the advertising material that claims that ibandronate has been proven to reduce the risk of nonvertebral fractures and that its efficacy against nonvertebral fractures is comparable to other bisphosphonates such as risedronate. The marketers of risedronate say that these claims are not supported by the label or by clinical-study data for ibandronate. They point out that, in its pivotal trial, the number of nonvertebral fractures in the ibandronate group was similar to that in the placebo group after three years [ 1 ]. In contrast, the clinical-trial data for risedronate show that it does reduce the risk of nonvertebral fractures [ 2 ], the manufacturers comment.

A lawsuit has been filed in a federal district court in New York seeking an injunction to stop the advertising.

New osteoporosis claim for hormone patch

Separately, use in the prevention of postmenopausal osteoporosis has been added as an indication to the labeling for the once-weekly transdermal hormone patch Climara Pro (estradiol/levonorgestrel), which is marketed by Berlex (the US affiliate of Schering AG, Germany). This product has already been available in the US for two years, but until now it was licensed for use in the relief of vasomotor symptoms associated with the menopause.

The approval for the additional indication was based on a two-year placebo-controlled trial in 150 women, which showed that the product significantly maintained bone-mineral density in the lumbar spine and hip compared with placebo, says the manufacturer.


  1. Chestnut III CH, Skag A, Christiansen C, et al. Effects of oral ibandronate administered daily or intermittently on fracture risk in postmenopausal osteoporosis. J Bone Miner Res 2004; 19:1241-1249.

  2. Harris ST, Watts NB, Genant HK, et al. Effects of risedronate treatment on vertebral and nonvertebral fractures in women with postmenopausal osteoporosis. JAMA 1999; 282:1344-1352.



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