Monthly Minodronate Dose Safe and Effective for Osteoporosis
Oral minodronate, when administered to osteoporosis patients as a daily 1 mg dose, has been shown to have antivertebral fracture efficacy. Japanese researchers wanted to see if a monthly minodronate dose of 30 mg or 50 mg would have similar efficacy—they looked specifically at the changes in bone mineral density (BMD) and bone turnover markers.
The results of their study—called “Efficacy and safety of monthly oral minodronate in patients with involutional osteoporosis”—were published online in September 2011 (and will soon be published in Osteoporosis International).
In this study, there were 692 patients with involutional osteoporosis. They were randomized into 3 groups:
- Receive minodronate as a 30 mg monthly dose
- Receive minodronate as a 50 mg monthly dose
- Receive minodronate as a daily dose of 1 mg
The percent change from baseline to 12 months in lumbar spine BMD (LS-BMD) was the primary endpoint. The researchers also looked at total hip BMD, bone turnover markers, parathyroid hormone (PTH) levels, and serum calcium (Ca).
In terms of change in LS-BMD, the monthly doses of mindronate (at 30 mg or 50 mg) were noninferior to the daily dose of 1 mg. Also changes in total hip BMD were comparable.
There was a transient decrease serum Ca and an increase in PTH level in all 3 groups at slightly different magnitudes and time courses. However, changes in bone turnover markers were comparable among the 3 groups with a similar time course.
Finally, safety profiles were also comparable.
This study shows that administering minodronate as a monthly dose of 30 mg or 50 mg has similar efficacy when compared to a daily dose of 1 mg. This is in terms of BMD and bone turnover markers. Monthly doses have a similar tolerability as the daily dose.
The researchers concluded that this study provides patients with a new option for minodronate.
This new regimen provides patients with a new option for taking minodronate.