La tunisie Medicale - 2009 ; Vol 87 ( n°06 ) : 380 - 381
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Summary

Aim : Bisphosphonates are powerful agents able to prevent bone loss. The objective of the study was to evaluate the efficacy and tolerability of risedronate once a week (35 mg) compared with risedronate 5 mg once daily in women with osteoporosis.
Methods: A randomized, double-blind, active-controlled study enrolled 102 postmenopausal women aged 66.5+7.5 years with osteoporotic fractures. All women received risedronate during 6 months. Group 1 (G1, n=51) received risedronate 5 mg once daily and group 2 (G2, n=51) received 35 mg once a week. Serum alkaline phosphatase (ALP), bone alkaline phosphatase (bone ALP), serum C-terminal telopeptide of type I collagen (CTX) were measured at
baseline, 3 months and 6 months after treatment in the two groups.
Results: We noted no significant difference in markers between women of the 2 groups. After 3 months, bone ALP and CTX decreased (respectively -22.1% and -47.6%) in the 2 groups with no significant difference between them. After 6 months study, bone ALP and CTX decreased respectively by -46.5% and -62.9% with no statistically significant difference between study groups for bone markers.
Conclusion: Our study found that treatment with once weekly risedronate 35 mg is able to decrease CTX and bone ALP compared with risedronate 5 mg once daily, in postmenopausal women with osteoporotic fractures. We didn’t find adverse events with the 35 mg once-a-week dose group compared to the once-daily dose group. Based on these results, the effects of risedronate 35 mg once a week are similar in efficacy to daily dosing and may lead less adverse events than once-a-month dose. This therapeutic protocol may  provide an alternative for patients who prefer once-a-week oral dosing.

Key - Words
Article

In postmenopausal osteoporosis, inhibition of bone resorption is a rational approach for prevention of bone loss. Bisphosphonates are powerful agents able to achieve this goal [1]. The objective of the current study was to evaluate the efficacy and tolerability of risedronate (oral bisphosphonate) once a week (35 mg) compared with risedronate 5 mg once daily in women with osteoporosis.

MATERIAL AND METHODS


Hundred and two postmenopausal women aged 66.5 + 7.5 years with osteoporotic fractures were included in the study. We obtained informed consent from all patients and the committee on clinical investigation at La Rabta hospital approved the study protocol. The bone mineral density (BMD) was measured by dual energy X-ray absorptiometry (DEXA) for all women and the mean of T-score was -1.93 + 0.79 in neck of femur and -3.31 + 1.13 in spine. We conducted a randomized, doubleblind, active-controlled study. All women received risedronate during 6 months. Group 1 (G1, n=51) received risedronate 5 mg once daily and group 2 (G2, n=51) received 35 mg once a week. Serum alkaline phosphatase (ALP), bone alkaline phosphatase (bone ALP), serum C-termilal telopeptide of type I collagen (CTX) were measured at baseline, 3 months and 6 months after treatment in the two groups. Statistical significance was defined as p<0.05. All statistical analyses were performed using SPSS 10.5. We used t-test of Student for comparison of means.

RESULTS


At baseline, there was no significant difference in ALP, bone ALP and CTX between women of the 2 groups.
All women continued and compelled all 6 months. After 3 months, bone ALP and CTX decreased (respectively -22.1% and -47.6%) in the 2 groups but with no significant difference between them. After 6 months study, bone ALP and CTX decreased respectively by -46.5% and -62.9%; no statistically significant differences between study groups were observed with bone markers (table 1).

Table 1 : Evolution of bone parameters at 3 and 6 months of treatment in the 2 groups of therapeutic protocols

 

DISCUSSION

Our results are comparable to those from Brown, Hooper et al and other published studies of risedronate therapy in postmenopausal osteoporotic women [2,3,4]. Primary efficacy assessment of the treatment was performed after 3 months. Our study found that treatment with once weekly risedronate 35 mg is able to decrease CTX and bone ALP compared with risedronate 5 mg once daily, in postmenopausal women with osteoporotic fractures. These various dosing options, including the ability to dose at spaced intervals, are a result of the ability of bisphosphonates to decrease the probability of trabecular perforations, and failure, and increase bone density [5].
Nevertheless, risedronate needs a minimum wait of 30 minutes after dosing before eating or drinking anything other than water. Delmas et al showed that risedronate150 mg once-a-month dose leads to symptoms associated with potential acute phase reaction that occurs more frequently in this group than in the daily dose group [6]. We didn’t find those adverse events in the 35 mg once-a-week dose group compared to the once-daily dose group. Based on these results, the effects of risedronate 35 mg once a week are similar in efficacy to daily dosing and may lead less adverse events than once-a-month dose. This therapeutic protocol may provide an alternative for patients who prefer once-a-week oral dosing. Moreover, reducing the dose of risedronate may also reduce the cost of medication.

Reference
  1. Choi HJ, Im JA, Kim SH. Changes in bone markers after onceweekly low-dose alendronate in postmenopausal women with moderate bone loss. Maturitas 2008, doi : 10. 1016/j. maturitas. 2008.05.003.
  2. Matti JV, Minguella JF, Halse J et al. Effects of risedronate 5mg/d on bone density and bone turnover markers in late-postmenopausal women with osteopenia: a multinational, 24-Month, parallel-group, Phase III Trial. Clin Ther 2007; 29:1937-49.
  3. Brown JP, Kendler DL, McClung MR et al. The efficacy and tolerability of Risedronate once a week for the treatment of postmenopausal osteoporosis. Calcif Tissue Int 2002; 71:103-11.
  4. hooper MJ, Ebeling PR, Robets AP et al. Risedronate prevents bone loss in early postmenopausal women: a prospective randomized, placebo-controlled trial Climacteric 2005; 8: 251-62.
  5. Eriksen EF, Melsen F, Sod E et al. Effects of long-term risedronate on bone quality and bone turnover in women with postmenopausal osteoporosis. Bone 2002; 31:620-5.
  6. Delmas PD, McClung MR, Zanchetta JR et al. Efficacy and safety of risedronate 150 mg once a month in the treatment of postmenopausal osteoporosis. Bone 2008; 42:36-42.
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