BONIVA Efficacy—Treatment of Postmenopausal Osteoporosis

Proven as clinically effective as Fosamax to increase BMD^1,2
Reverses bone loss in 9 out of 10 women³
Reduces vertebral fracture risk^4,5
Provides nonvertebral fracture protection in high-risk patients (post hoc analysis)⁶

Proven as clinically effective as Fosamax to increase BMD

Once-monthly BONIVA achieved clinically comparable BMD improvements vs once-weekly Fosamax in a head-to-head noninferiority trial.¹

Chart: Head-to-head MOTION trial: BMD increases across all sites measured(1)

The Monthly Oral Therapy with Ibandronate for Osteoporosis iNtervention (MOTION) noninferiority trial consisted of 1733 treated women, aged 55 to 84 years with postmenopausal osteoporosis. This 12-month, randomized, double-blind, double-dummy, parallel-group, multicenter trial compared the efficacy of once-monthly oral ibandronate (150 mg) with once-weekly oral alendronate (70 mg). Primary endpoints were relative change (%) from baseline in mean lumbar spine (L2-L4) BMD and in mean total hip BMD at 12 months. Per-protocol population consisted of 725 women (BONIVA) and 720 women (Fosamax). Fracture was not an efficacy endpoint in this trial. Fosamax is a registered trademark of Merck & Co., Inc.

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BONIVA demonstrated clinically comparable BMD improvements vs Fosamax in a head-to-head trial at all sites measured¹

Primary endpoints: lumbar spine, total hip
Additional endpoints: trochanter, femoral neck*

Clinical effectiveness was defined by a noninferiority margin, which was predefined as 1.41% for lumbar spine and 0.87% for total hip

*Post hoc analysis.

Overall adverse events similar to Fosamax

Chart: Most commonly experienced adverse events (=>5%) similar to Fosamax in a head-to-head trial(1)

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$Chart: Low rates of osteoporotic fractures reported as adverse events in a head-to-head trial(2)$

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In the head-to-head trial, fracture data were reported as adverse events. Therefore, these data should not be interpreted as an efficacy endpoint or evidence of fracture risk reduction

Reverses bone loss in 9 out of 10 women

Chart: BMD increases in 9 out of 10 women at year 1 (MOBILE Trial)(3)

The Monthly Oral IBandronate In LadiEs (MOBILE) study was a 2-year, randomized, double-blind, phase III, noninferiority trial designed to confirm that once-monthly dosing was as effective as daily dosing in increasing lumbar spine BMD at year 1. Women with postmenopausal osteoporosis (N=1609) were assigned to one of four oral ibandronate regimens, including 2.5 mg daily (n=395) and 150 mg once-monthly (n=396). All patients took 400 IU vitamin D and 500 mg calcium supplementation each day.

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BONIVA was clinically proven at 1 year to provide BMD increases from baseline in 9 out of 10 patients at lumbar spine, total hip, or trochanter, and in 3 out of 4 patients at femoral neck⁷

Delivers proven fracture protection

BONIVA provided 52% vertebral fracture risk reduction in the overall population from the BONE trial at year 3 (BONIVA 2.5 mg [9.6%] daily vs placebo [4.7%])⁶

For younger patients taking BONIVA plus calcium and vitamin D, fracture incidence was 1.2%. For younger patients in the placebo arm taking calcium and vitamin D alone, fracture incidence was 13.8%⁵

$Chart: Reduced vertebral fracture risk in younger postmenopausal women (BONE Trial)(4,5,*) (post hoc analysis in women aged <65 years)†$

The Oral IBandronate Osteoporosis Vertebral Fracture Trial in North America and Europe (BONE) consisted of 2946 women aged 55 to 80 years with postmenopausal osteoporosis. In this 3-year, double-blind trial, women were randomized to one of three regimens, including placebo (n=975) and BONIVA 2.5 mg daily (n=977). All patients took 400 IU vitamin D and 500 mg calcium supplementation each day. The primary endpoint was the incidence of new vertebral fractures after 3 years of treatment.

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^†Subpopulation intent-to-treat (ITT) analysis of women aged <65 years with baseline mean lumbar spine T-scores <-2.0.

Provides nonvertebral fracture protection in high-risk patients^‡

$Chart: 69% nonvertebral fracture risk reduction in high-risk patients (BONE Trial) (post hoc analysis)(6‡)$

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^‡Subpopulation ITT analysis of postmenopausal women from the BONE study with baseline femoral neck T-score <-3.0, BONIVA 2.5 mg (n=123) vs placebo (n=124).⁸

In the overall BONE study population, the effect of BONIVA on nonvertebral fractures was similar to that of placebo
The mean baseline femoral neck BMD T-score was -2.0 for the overall study population, indicating lower risk for nonvertebral fractures
In a post hoc analysis of patients with baseline femoral neck BMD T-score <-3.0, indicating a higher risk for nonvertebral fracture, BONIVA 2.5 mg daily significantly reduced the risk of nonvertebral fractures