At this point, alendronate oral jelly is available only in Japan. We conducted the comparative trial of alendronate oral jelly (ALN-J) versus alendronate weekly tablet (ALN-T) to clarify the effect of alendronate oral jelly in the treatment of osteoporosis in Japanese clinical settings. The patients were assigned to ALN-J or ALN-T group in accordance with their request in each institution and observed for 6 months. The endpoints were bone turnover marker, bone mineral density (BMD), safety and others. As a result, 94 patients were enrolled in this trial from ten institutions, and 65 patients (female, 62; male, 3) assigned to the ALN-J group and 29 patients (female, 27; male, 2) to the ALN-T group. Mean [SD] of age was 77.5 [7.6] in the ALN-J group and 76.0 [6.6] in ALN-T group, and proportion of history of fracture was over 70% in each group. TRACP-5 decreased by 38.8% in the ALN-J group and 36.8% in the ALN-T group at 3 months and 44.0% in both groups at 6 months. P1NP decreased by 44.2% in the ALN-J group and 45.9% in the ALN-T group at 3 months, and 51.6% and 57.8% at 6 months, respectively. Lumbar spine BMD increased by 3.6% in the ALN-J group and 4.2% in the ALN-T group at 6 months, hip BMD 1.3% and 0.8%, radius BMD 0.9% and -0.1%, respectively. Alendronate oral jelly has equal effectiveness to alendronate weekly tablet.
Disclosure: The authors declared no competing interests.