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Title: Rapid Improvement Seen in Osteoporotic Patients Who Adhere to Weekly Alendronate Schedule: Presented at ASBMR

"Rapid Improvement Seen in Osteoporotic Patients Who Adhere to Weekly Alendronate Schedule: Presented at ASBMR"

By Bonnie Darves SEATTLE, WA -- October 5, 2004 -- Patients with osteoporosis who adhere to a high-dose, weekly schedule of the bisphosphonate alendronate may begin experiencing reduced bone resorption as early as 5 weeks into treatment. Lead author, Michel Djandji, MD, clinical researcher, Merck Frosst Canada, presented the results of the early effects and safety of the alendronate (Fosamax®) 70 mg once-weekly EASY study here October 3[^rd at the American Society for Bone and Mineral Research annual meeting.

In subjects who were most adherent to treatment, there was a 48% reduction in bone resorption, and the effect was seen as early as 5 weeks after starting treatment, according to Dr. Djandji.

"This result, if seen in future studies, may motivate physicians and patients to start treatment as soon as possible after diagnosis," Dr. Djandji said. "Even though osteoporosis develops over the long term, the emerging evidence that it can be reversed rapidly and effectively may promote better treatment adherence—and it may have important implications for patient management in the future."

The study involved 259 men and women (85% women) with confirmed osteoporosis, who had not received previous treatment for the condition. The mean age was 67 years and baseline mean urine bone turnover (urinary NTx) was 54.0. Patients received a once-weekly dose of alendronate for 13 weeks. NTx was measured at five and 13 weeks.

The researchers found a bone resorption reduction of 35% in the overall cohort. Benefits were seen regardless of patient gender or age, Dr. Djandji noted, and were most pronounced in patients who took each weekly dose.

He acknowledged that the small study sample size was a limitation that prevented results from achieving statistical significance, but said the results are "promising nonetheless."

A total of 218 patients completed the treatment cycle, and 12 patients withdrew because of adverse events, most of which were mild to moderate in nature. Two withdrew because of severe abdominal pain and gastrointestinal discomfort.

[Presentation title: "Early Effects and Safety of Alendronate (Fosamax®) 70 mg Once Weekly (EASY)." Abstract SU448]

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