Oral Ibandronate as Effective as Intravenous Treatment in Primary Osteoporosis: Presented at ASBMR

By Matt Silver

SAN FRANCISCO -- October 14, 2015 -- Oral ibandronate is as effective as intravenous ibandronate for increasing bone mineral density in Japanese patients with primary osteoporosis, according to a study presented here at the 37th Annual Meeting of the American Society for Bone and Mineral Research (ASBMR).

Toshitaka Nakamura, MD, National Center for Global Health & Medicine, Tokyo, Japan, presented the study on October 12.

The researchers compared the efficacy and safety of monthly oral ibandronate with the licensed monthly intravenous dose in Japanese patients with primary osteoporosis.

The study included 372 ambulatory Japanese patients aged ≥55 years who had primary osteoporosis. The patients were randomised to receive oral ibandronate 100 mg plus intravenous placebo monthly or intravenous ibandronate 1 mg plus oral placebo monthly.

Both groups showed similar and substantial gains in bone mineral density at all sites after 12 months and significant improvement from baseline after just 4 months. At 12 months, the mean relative change from baseline in lumbar spine bone mineral density was 5.22% with oral ibandronate treatment, versus 5.34% with intravenous treatment.

The least-squares mean difference between the groups was -0.23%, showing that oral treatment is noninferior to the intravenous treatment (noninferiority limit, -1.60), which was the primary endpoint of the study. Gains were also seen in bone mineral density at the total hip and femoral neck. Furthermore, the groups had a similar proportion of treatment responders at all sites, with a substantial reduction in bone turnover markers after 4 months.

No differences between the groups were seen in regard to safety. The incidence of acute-phase reactions was 11.2% with oral treatment and 11.8% for intravenous treatment. Most reactions were mild and transient and decreased with every dosing. No adverse events related to renal function occurred, nor did hypocalcaemia, osteonecrosis of the jaw, or atypical femur fractures.

Funding for the study was provided by Chugai Pharmaceutical Co. Ltd and Taisho Pharmaceutical Co. Ltd.

[Presentation title: Monthly Oral Ibandronate 100mg Is as Effective as Monthly Intravenous Ibandronate 1mg in Japanese Patients With Primary Osteoporosis: The Phase III MOVEST Study. Abstract SU0344]

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