|
At the 5-mg dose, decreases in deoxypyridinoline/ creatinine were evident within 14 days of treatment. Changes in bone formation markers were observed later than changes in resorption markers, as expected, due to the coupled nature of bone resorption and bone formation; decreases in bone specific alkaline phosphatase of about 20% were evident within 3 months of treatment. Bone turnover markers reached a nadir of about 40% below baseline values by the sixth month of treatment and remained stable with continued treatment for up to 3 years. Bone turnover is decreased as early as 14 days and maximally within about 6 months of treatment, with achievement of a new steady-state that more nearly approximates the rate of bone turnover seen in premenopausal women. In a 1-year study comparing daily versus weekly oral dosing regimens of ACTONEL for the treatment of osteoporosis in postmenopausal women, ACTONEL 5-mg daily and ACTONEL 35-mg once a week decreased urinary collagen cross-linked N-telopeptide by 60% and 61%, respectively. In addition, serum bone-specific alkaline phosphatase was also reduced by 42% and 41% in the ACTONEL 5-mg daily and ACTONEL 35-mg once a week groups, respectively. ACTONEL is not an estrogen and does not have the benefits and risks of estrogen therapy. Text Continues Below
As a result of the inhibition of bone resorption, asymptomatic and usually transient decreases from baseline in serum calcium (< 1%) and serum phosphate (< 3%) and compensatory increases in serum PTH levels (< 30%) were observed within 6 months in patients in osteoporosis clinical trials. There were no significant differences in serum calcium, phosphate, or PTH levels between the ACTONEL and placebo groups at 3 years. In a 1-year study comparing daily versus weekly oral dosing regimens of ACTONEL in postmenopausal women, the mean changes from baseline at 12 months were similar between the ACTONEL 5-mg daily and ACTONEL 35-mg once a week groups, respectively, for serum calcium (0. 4% and 0.7%), phosphate (-3. 8% and -2. 6%) and PTH (6. 4% and 4.2%). Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
|
.gif)
