The role of zoledronic acid in the management of osteoporosis |
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Authors: | Michael Maricic |
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Institution: | (1) Catalina Pointe Clinical Research, Inc., University of Arizona School of Medicine, 5501 N. Oracle Road, Suite 161, Tucson, AZ 85704, USA |
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Abstract: | Bisphosphonates are the current standard of care for treatment of osteoporosis. However, oral bisphosphonates are associated
with complicated dosing regimens because of poor absorption and have the potential for upper gastrointestinal (GI) tract irritation,
resulting in poor adherence and persistence. Zoledronic acid (ZOL) 5 mg, a once-yearly intravenous bisphosphonate, is approved
for treatment and prevention of postmenopausal osteoporosis, increasing bone mass in men with osteoporosis, and treatment
and prevention of glucocorticoid-induced osteoporosis. Because it is administered as an infusion, ZOL ensures adherence and
persistence over the entire 12-month dosing interval and bypasses the GI absorption/irritation problems associated with oral
bisphosphonates. The objective of this study was to review the safety and efficacy of 5 mg ZOL and its potential for improving
patient compliance. Published reports dating back to 2001 were reviewed, with emphasis on osteoporosis treatment. In the HORIZON-Pivotal
Fracture Trial, annual infusions of 5 mg ZOL produced significant reductions in risk of morphometric vertebral fractures (70%)
and hip fractures (41%) vs placebo over 3 years in postmenopausal women with osteoporosis. In the HORIZON-Recurrent Fracture
Trial, an annual infusion of 5 mg ZOL after repair of a recent low-trauma hip fracture was associated with significant reductions
in risk for new clinical fractures (35%) vs placebo. In men with osteoporosis, an annual treatment of ZOL over 2 years increased
lumbar spine bone mineral density (BMD) by 6% compared with baseline. In patients starting or continuing treatment with chronic
glucocorticoids, ZOL resulted in significantly greater increases in lumbar spine BMD over 1 year than an oral bisphosphonate.
In postmenopausal women with osteopenia, a single infusion of ZOL over a 2-year period produced significantly greater gains
in lumbar spine and hip BMD than placebo. ZOL is generally safe and well tolerated. Five milligrams of ZOL has the potential
to improve compliance with osteoporosis therapy and, consequently, to reduce fracture risk in clinical practice. |
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