BONIVA Injection Efficacy

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Efficacy

BONIVA Quarterly Injection provided BMD increases in lumbar spine and total hip that were significant and progressive over a 2-year trial(1-2)

DIVA Trial:

Chart: DIVA Trial—BMD Increases at Lumbar Spine and Total Hip(3)

The Dosing IntraVenous Administration (DIVA) trial was a 2-year, randomized, double-blind, double-dummy, phase III, noninferiority trial designed to confirm that once-quarterly injectable dosing was as effective as daily dosing in increasing lumbar spine BMD at year 1. Women with postmenopausal osteoporosis (N=1358) were assigned one of three ibandronate regimens including 2.5 mg daily (n=457) and 3 mg once-quarterly injection (n=459). All patients took 400 IU vitamin D and 500 mg calcium supplementation daily. Values represent intent-to-treat population.

Responder analysis:

At year 2, BONIVA Injection was clinically proven to maintain or increase BMD from baseline in^4,5:
— 9 out of 10 patients at lumbar spine
— 4 out of 5 patients at total hip and trochanter
— 3 out of 4 patients at femoral neck

BONIVA Injection is indicated for the treatment of osteoporosis in postmenopausal women.

All daily bisphosphonate therapies for the treatment and prevention of postmenopausal osteoporosis were approved by demonstrating fracture reduction versus placebo. Approval of extended dosing regimens for bisphosphonates was based on demonstrating increases in bone mineral density (BMD) similar to those of the approved daily dose.

$BONIVA reduces risk of fracture$

BONE Trial:

BONIVA significantly reduces vertebral fracture risk vs placebo^1,2,6

Chart: BONE Trial: Vertebral Fracture Risk Reduction vs Placebo(1,2,6)

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.

BONIVA provides early and sustained BMD increases

BONE Trial:

BONIVA significantly increases BMD as early as 6 months^1,7

Chart: BONE Trial—BMD Increases as Early as 6 Months(1,7)

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Image: Sarah, Age 63, Suffers from dysphagia

Not an actual patient.

References:
1. Chesnut CH, Ettinger MP, Miller PD, et al. Ibandronate produces significant, similar antifracture efficacy in North American and European women: new clinical findings from BONE. Curr Med Opin. 2005;21:391-401.
2. Chesnut CH III, Skag A, Christiansen C, et al. Effects of oral ibandronate administered daily or intermittently on fracture risk in postmenopausal osteoporosis. J Bone Miner Res. 2004;19:1241-1249.
3. Data on file (Ref. #161-158), Genentech USA, Inc., South San Francisco, CA.
4. Data on file (Ref. #161-157), Genentech USA, Inc., South San Francisco, CA.
5. Delmas PD, Adami S, Strugala C, et al. Intravenous ibandronate injections in postmenopausal women with osteoporosis: one-year results from the Dosing Intravenous Administration study. Arthritis Rheum. 2006;54:1838-1846.
6. Data on file (Ref. #161-013), Genentech USA, Inc., South San Francisco, CA.
7. Data on file (Ref. #161-014), Genentech USA, Inc., South San Francisco, CA.

BONIVA Injection is indicated for the treatment of osteoporosis in postmenopausal women.

Important Safety Information for BONIVA Injection
BONIVA Injection is contraindicated in patients with uncorrected hypocalcemia or known hypersensitivity to BONIVA Injection or any of its excipients. BONIVA Injection, like other bisphosphonates administered intravenously, may cause a transient decrease in serum calcium values. Hypocalcemia, hypovitaminosis D, and other disturbances of bone and mineral metabolism must be effectively treated before starting therapy. Patients must receive supplemental calcium and vitamin D. BONIVA Injection must be administered intravenously only by a healthcare professional. Patients who receive BONIVA Injection should have serum creatinine measured prior to each dose. BONIVA Injection should not be administered to patients with severe renal impairment (serum creatinine >2.3mg/dL or creatinine clearance <30 mL/min). Rarely, patients have reported severe bone, joint, and/or muscle pain after taking bisphosphonate therapy for osteoporosis. Osteonecrosis of the jaw has been reported in patients treated with bisphosphonates; most cases have been in cancer patients undergoing dental procedures who received intravenous bisphosphonates.

In a one-year study comparing BONIVA Injection 3 mg quarterly and BONIVA Tablets 2.5mg daily, the overall safety and tolerability profiles of the two dosing regimens were similar. The most commonly reported adverse events (>5.0%), regardless of causality, were arthralgia (9.6% BONIVA Injection vs 8.6% BONIVA Tablets 2.5 mg), back pain (7.0% vs 7.5%), hypertension (5.3% vs 7.1%), abdominal pain (5.1% vs 5.6%), influenza (4.7% vs 8.0%) and nasopharyngitis (3.4% vs 6.0%). In some patients acute phase reaction-like events (10% BONIVA Injection vs 4% BONIVA Tablets) have been reported within 3 days of an IV dose and lasting for 7 days or less, most commonly after the first injection. In most cases, no specific treatment was required and symptoms subsided within 24-48 hours.

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