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Weekly Risedronate as Good as Daily for Osteoporosis: Presented at WCO

By Adrian Burton
Special to DG News

LISBON, PORTUGAL -- May 14, 2002 -- Once-weekly doses of risedronate 35 mg increase the bone mineral density (BMD) of the lumbar spine and hip of postmenopausal women as effectively as the standard 5 mg daily regimen, according to researchers.

Weekly dosing could free many patients from the inconvenience of daily doses that must be taken on an empty stomach.

"One of the major issues clinicians face today is how to help patients adhere to their therapy: how do we make it convenient enough for them," said Jonathon Adachi, MD, professor of medicine at McMaster University, Hamilton, Ontario, Canada.

"Earlier studies have shown once-weekly dosing can be a more convenient treatment. We wanted to know the safety and efficacy of risedronate at different weekly doses," he said. Dr. Adachi presented the findings here Monday at the International Osteoporosis Foundation World Congress on Osteoporosis (WCO).

The double-blind, randomised study was conducted in Canada and the United States and included 1,456 osteoporotic women aged 50 or older, all of whom were more than five years past menopause. For enrollment, women had to have a lumbar spine T-score of less than -2.5 or less than -2.0 and at least one important vertebral fracture.

The researchers divided the women into three dosing groups: 480 received 5 mg risedronate daily; 485 received 35 mg once a week; and 491 received 50 mg once a week. The women in the weekly dosing groups took placebo tablets on non-dosing days.

At 12 months, all dosing regimens provided similar increases in lumbar spine bone mineral density (BMD) over baseline levels (4.00 percent, 3.94 percent, and 4.25 percent, respectively). Total hip BMD, femoral neck BMD, and trochanteric BMD were also increased by similar amounts. Differences between the various dosing regimens were less than 0.5 percent.

Reductions in bone turnover markers showed a similar trend. N-telopeptide /creatinine ratios were down from baseline by 60 percent, 61 percent, and 65 percent, respectively, and bone alkaline phosphatase levels were down 42 percent, 41 percent, and 46 percent, respectively.

There were no differences in adverse effects -- including gastrointestinal problems -- between the three regimens. Once-weekly regimens therefore appear to be as effective as the once-daily standard, and because no extra benefit was seen with the 50 mg weekly dose, the most recommendable dose is 35 mg weekly, said Dr. Adachi.

"The number one thing for the younger working person really does come down to convenience," he said. "You may have 8:00 appointments and you want breakfast, but you can't have any because you have to take your pill on a daily basis -- so maybe you don't take it. If you could take just one pill on the weekend, people could tolerate this much better."

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