Treatment of Paget's disease of bone with alendronate.

In summary, the clinical efficacy studies provide clear evidence that treatment with oral alendronate markedly suppresses bone turnover and produces clinical improvement in pagetic patients. Serum alkaline phosphatase was greatly decreased by treatment, and the response to alendronate was superior to that observed for currently available therapies such as etidronate and calcitonin, which usually reduce alkaline phosphatase, on average, by 40%-50%. Alendronate also markedly reduced urinary resorption markers and induced radiologic improvement of pagetic osteolysis. A majority of alendronate-treated patients normalized their serum alkaline phosphatase by month 6. This observation is likely to be relevant to the duration of response to treatment, as previous studies have shown that the degree of suppression of alkaline phosphatase after antiresorptive treatment correlates with the duration of remission. Therefore, patients who responded to treatment with alendronate, especially those who normalized their alkaline phosphatase levels, are likely to maintain the biochemical remission for several years. Indeed, preliminary unpublished data seem to indicate that alendronate is capable of producing long-term biochemical remission in the majority of patients. In addition to its efficacy, the safety and tolerability profile of alendronate 40 mg/day was very favorable and, overall, comparable to that of placebo.

RCT Entities:   Population Interventions Outcomes