+ Site Statistics
+ Search Articles
+ PDF Full Text Service
How our service works
Request PDF Full Text
+ Follow Us
Follow on Facebook
Follow on Twitter
Follow on LinkedIn
+ Subscribe to Site Feeds
Most Shared
PDF Full Text
+ Translate
+ Recently Requested

Insufficiently dosed intravenous ibandronate injections are associated with suboptimal antifracture efficacy in postmenopausal osteoporosis



Insufficiently dosed intravenous ibandronate injections are associated with suboptimal antifracture efficacy in postmenopausal osteoporosis



Bone 34(5): 890-899



Less frequent bisphosphonate dosing in women with postmenopausal osteoporosis has the potential to promote therapy adherence through improved convenience. Ibandronate is a highly potent nitrogen-containing bisphosphonate, proven to significantly increase vertebral and nonvertebral bone mineral density (BMD) when administered as a convenient intravenous injection. A recent double-blind, placebo-controlled, randomized phase III study explored the antifracture efficacy and safety of 1 and 0.5 mg iv ibandronate injections, given once every 3 months, in 2862 women (55-76 years) with postmenopausal osteoporosis [one to four prevalent vertebral fractures and lumbar spine (L1-L4) BMD T score of less than -2.0 and greater than -5.0 in >or=1 vertebra]. All participants received daily vitamin D (400 IU) and calcium (500 mg) supplementation. The primary endpoint was the incidence of new morphometric vertebral fractures after 3 years. However, although a consistent trend toward a reduction in the incidence of new morphometric vertebral fracture was observed in the active treatment arms compared with placebo (9.2% vs. 8.7% vs. 10.7% in the 1 mg, 0.5 mg and placebo groups, respectively), as well as in the incidence of nonvertebral and hip fractures, the magnitude of fracture reduction was suboptimal and was insufficient to achieve statistical significance. At the studied doses, intravenous ibandronate injections also produced dose-dependent, but comparatively small, increases in lumbar spine BMD (4.0% and 2.9%, respectively) and decreases in biochemical markers of bone resorption and formation, relative to placebo. Optimal fracture efficacy likely requires more substantial increases in BMD and more pronounced suppression of bone turnover. In light of the clear dose-response relationship observed in this and other studies, this is likely to be achieved with higher intravenous doses of ibandronate. The results of a recent phase II/III study (Intermittent Regimen Intravenous Ibandronate Study: the IRIS study) provide support for this hypothesis.

Please choose payment method:






(PDF emailed within 0-6 h: $19.90)

Accession: 012220524

Download citation: RISBibTeXText

PMID: 15121021

DOI: 10.1016/j.bone.2004.01.008


Related references

Efficacy of Intravenous Ibandronate Injections in Postmenopausal Osteoporosis: DIVA 2-Year Findings. Journal of Clinical Densitometry 9(2): 247-248, 2006

Efficacy and tolerability of intravenous ibandronate injections in postmenopausal osteoporosis: 2-year results from the DIVA study. Journal of Rheumatology 35(3): 488-497, 2008

Intravenous injections of ibandronate (IB) in the treatment of postmenopausal osteoporosis. Osteoporosis International 6(1 Suppl.): 94-94, 1996

Intravenous ibandronate injections in postmenopausal women with osteoporosis: one-year results from the dosing intravenous administration study. Arthritis and Rheumatism 54(6): 1838-1846, 2006

Tri-monthly intravenous injections of ibandronate for treatment of postmenopausal osteoporosis. Journal of Bone & Mineral Research 16(Suppl 1): S406, 2001

Three monthly intravenous injections of ibandronate in the treatment of postmenopausal osteoporosis. American Journal of Medicine 103(4): 298-307, 1997

Effects of intermittent intravenous ibandronate injections on bone quality and micro-architecture in women with postmenopausal osteoporosis: the DIVA study. Bone 46(3): 660-665, 2010

Quarterly intravenous ibandronate injections provide continuing benefits in women with postmenopausal osteoporosis: DIVA study long-term extension. 2007

Antifracture efficacy of currently available therapies for postmenopausal osteoporosis. Drugs 71(1): 65-78, 2011

Protelos: nonvertebral and hip antifracture efficacy in postmenopausal osteoporosis. Bone 38(2 Suppl 1): 23-27, 2006

Antifracture efficacy of strontium ranelate in postmenopausal osteoporosis. Bone (New York) 40(5, Suppl. 1): S9-S11, 2007

Ibandronate injections in postmenopausal women with osteoporosis. Current Rheumatology Reports 9(1): 47; Discussion 48-9, 2007

Maintenance of antifracture efficacy over 1 years with strontium ranelate in postmenopausal osteoporosis. 2011

Maintenance of antifracture efficacy over 10 years with strontium ranelate in postmenopausal osteoporosis. Osteoporosis International 23(3): 1115-1122, 2012

Quarterly intravenous ibandronate for postmenopausal osteoporosis. Women's Health 4(3): 219-228, 2008