Once-Weekly Alendronate as Safe as Daily Therapy.

DENVER -- Once-weekly alendronate is therapeutically equivalent to daily dosing of the bisphosphonate in postmenopausal osteoporosis, according to the 2-year results of a large clinical trial.

The new 2-year extension data confirm the results of the original 1-year study that last year persuaded the Food and Drug Administration to grant marketing approval for once-weekly alendronate (Fosamax) in a 70-mg tablet.

The 2-year double-blind, multicenter, randomized trial involving more than 1,200 postmenopausal women with osteoporosis also showed that the safety profile was the same regardless of whether the drug was given on a schedule of 10 mg/day, 35 mg twice weekly, or 70 mg once weekly. There was a nonsignificant trend toward better tolerability with once-weekly therapy Dr. Henry Bone reported at the annual meeting of the Endocrine Society.

There's no question that once-weekly therapy is more convenient. Alendronate must be taken with plain water following an overnight fast, and no food or drink is to be consumed for half an hour afterward. "Once-a-week therapy is a nice alternative. It simplifies things for many patients," said Dr. Bone, director of the Michigan Bone and Mineral Clinic, Detroit.

The study design doesn't permit assessment of any compliance differences, but there's widespread hope among osteoporosis experts that once-weekly therapy will result in improved compliance.

"Outside the study the majority of my patients have opted for once-weekly therapy, but some are happy with once-daily. In this situation it's largely a matter of preference. The medical effect is identical" the endocrinologist observed.

In the Merck & Co.-funded trial, similar increases in bone mineral density in the lumbar spine--the primary study end point--were found with 2 years of treatment with each dosing ...