The effectiveness and safety of BONIVA once monthly were demonstrated in a randomized, double-blind, multinational, noninferiority trial in 1602 women aged 54 to 81 years, who were on average 18 years postmenopause, and had L2-L4 lumbar spine BMD T-score below -2.5 SD at baseline. The main outcome measure was the comparison of the percentage change from baseline in lumbar spine BMD after 1 year of treatment with once-monthly ibandronate (100 mg, 150 mg) to daily ibandronate (2.5 mg). All patients received 400 IU vitamin D and 500 mg calcium supplementation per day.

Effect on Vertebral Fracture

BONIVA 2.5 mg daily significantly reduced the incidence of new vertebral and of new and worsening vertebral fractures. Over the course of the 3-year study, the risk for vertebral fracture was 9.6% in the placebo-treated women and 4.7% in the women treated with BONIVA 2.5 mg (p < 0.001) (see Table 1).

Table 1: Effect of BONIVA on the Incidence of Vertebral Fracture in the 3-Year Osteoporosis Treatment Study*

Effect on Nonvertebral Fractures

There was a similar number of nonvertebral osteoporotic fractures at 3 years reported in women treated with BONIVA 2.5 mg daily [9.1%, (95% CI: 7.1%, 11.1%)] and placebo [8.2%, (95% CI: 6.3%, 10.2%)]. The two treatment groups were also similar with regard to the number of fractures reported at the individual nonvertebral sites: pelvis, femur, wrist, forearm, rib, and hip.

Effect on Bone Mineral Density (BMD)

BONIVA significantly increased BMD at the lumbar spine and hip relative to treatment with placebo. In the 3-year osteoporosis treatment study, BONIVA 2.5 mg daily produced increases in lumbar spine BMD that were progressive over 3 years of treatment and were statistically significant relative to placebo at 6 months and at all later time points. Lumbar spine BMD increased by 6.4% after 3 years of treatment with 2.5 mg daily BONIVA compared with 1.4% in the placebo group. Table 2 displays the significant increases in BMD seen at the lumbar spine, total hip, femoral neck, and trochanter compared to placebo. Thus, overall BONIVA reverses the loss of BMD, a central factor in the progression of osteoporosis.

Table 2 : Mean Percent Change in BMD from Baseline to Endpoint in Patients Treated Daily with BONIVA 2.5 mg or Placebo in the 3-Year Osteoporosis Treatment Study*

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