Procter and Gamble announces phase II results for risedronate

Procter & Gamble (P&G) has announced the publication of the results of a phase III clinical trial of risedronate, a treatment for postmenopausal osteoporosis.

The data, presented in the current issue of the Bone journal, compared the administration of risedronate 150 mg once a month to a once-daily five mg dose of the compound.

Patients in both groups – whose treatment was supplemented with vitamin D and calcium – saw a similar increase in lumbar spine bone mineral density when measured at one year.

The BMD was measured at the lumbar spine, total hip, femoral neck and femoral trochanter, with no significant difference seen between the treatment groups.

Additionally, the safety and tolerability profiles for the drugs were similar for both dosing regimens of the drug.

Nora Zorich, vice-president of global research and development at P&G Pharmaceuticals, said: “Our goal is to provide patients with convenient dosing options for risedronate.”

She added that if the 150 mg monthly regimen is approved by regulators, it will increase the number of treatment options open to patients desiring less frequent dosing of the drug.

At the annual meeting of the American Society for Bone and Mineral Research in October 2007, Michael McLung, founding director of the Oregon Osteoporosis Centre in Portland, claimed that risedronate showed that risedronate had already been approved as reducing the risk of both spinal and nonspinal fractures.