Efficacy of generic alendronate and ibandronate in post menopausal osteoporosis

Objective: To determine whether generic non innovator once weekly oral alendronate is as effective as the innovator once oral Ibandronate.

Method: This was an open label, prospective, randomized control trial conducted at the endocrine unit at the National Hospital of Sri Lanka. Postmenopausal women with a BMD T score of <-1.0 were recruited for the trial after excluding those with secondary causes for osteoporosis. Prior to the start of the study all subjects were given a single injection of Vitamin D3 200 000 IU. They were thereafter randomized to the alendronate and ibandronate arms. Alendronate arm received alendronate 70 mg once weekly and the ibandronate arm received ibandronate 150 mg once monthly for 3 months. Serum Beta crosslaps (CTX) was measured before and after bisphosphonate treatment. The treatment outcome was assessed using two parameters; i) percentage reduction of CTX and ii) treatment success, defined as greater than 35% reduction in baseline CTX.

Results: Out of 77 women who entered the study 32 women in the alendronate group and 39 women in the ibandronate group completed treatment with 3 drop outs in each group. Mean ages, age since menopause and pre treatment CTX were similar in both groups.

Percentage reduction in beta cross laps levels showed a marginally significant difference favouring the alendronate group (P<0.05).

Treatment success rates were 93.8 percent in the alendronate group and 89.7 percent in the ibandronate group. The difference was not statistically significant.

Conclusions: Our study shows that the generic preparation of alendronate is effective in the treatment of osteoporosis.

DOI: http://dx.doi.org/10.4038/sjdem.v1i1.4182  

Sri Lanka Journal of Diabetes Endocrinology and Metabolism 2011; 1: 14-17