HOBOKEN, NJ -- October 29, 2009 -- Patients with glucocorticoid-induced osteoporosis (OP) who are treated with teriparatide for 36 months have a greater increase in bone mineral density (BMD) and fewer new vertebral fractures than those treated with alendronate, according to a study published in the November issue of Arthritis & Rheumatism.
The 36-month, randomised, double-blind, controlled trial, led by Kenneth Saag, MD, University of Alabama, Birmingham, Alabama, included 428 patients aged 22 to 89 years with confirmed OP who had received prednisone >=5 mg/day for more than 3 months preceding screening were included.
Research measures included changes in lumbar spine and hip bone, BMD, changes in bone biomarkers, fracture incidence, and safety.
Patients were randomly assigned to receive injectable teriparatide 20 mcg/day plus oral placebo (n = 150) or oral alendronate 10 mg/day plus injectable placebo (n = 144). Supplements of calcium (1,000 mg/day) and vitamin D (800 IU/day) were provided to all study participants. Patients kept a daily journal to record their steroid use.
Results showed that at 36 months, BMD for lumbar spine was 11% higher than baseline in the teriparatide group compared with 5.3% in the alendronate group. The BMD (teriparatide vs alendronate) for total hip was 5.2% versus 2.7% and 6.3% versus 3.4% for femoral neck.
Researchers also observed fewer vertebral fractures in patients taking teriparatide (1.7%) than those administered alendronate (7.7%). Higher levels of calcium concentrations were noted in the teriparatide group (21%) than in the alendronate group (7%).
"There is a significant number of individuals who are regularly treated with steroids to control inflammation which puts them at risk for developing osteoporosis," said Dr. Saag. "A need for therapies that mitigate this side-effect of steroid use and substantially improves bone mass is vital."
"Our research shows that teriparatide is a safe and effective treatment for patients with steroid-induced OA and should be considered as a therapeutic option for those at high risk of bone fracture," recommended Dr. Saag.
SOURCE: Wiley Blackwell