Teriparatide Better Than Alendronate for Treatment of Glucocorticoid-Induced Osteoporosis After 36 Months: Presented at ASBMR

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Title: Teriparatide Better Than Alendronate for Treatment of Glucocorticoid-Induced Osteoporosis After 36 Months: Presented at ASBMR
URL: http://www.pslgroup.com/dg/22CC02.htm
Doctor's Guide
September 18, 2008

By Louise Gagnon

MONTREAL -- September 18, 2008 -- Teriparatide, a recombinant form of parathyroid hormone, is an effective therapeutic option for patients at high risk of fracture who have developed osteoporosis as a result of steroid therapy, according to study results presented here at the 30th Annual Meeting of the American Society of Bone and Mineral Research (ASBMR).

Continuous use of corticosteroids is known to contribute to deficits in bone mineral density (BMD) and increase the risk of new fractures.

The 36-month results of a multicentre, double-blind, clinical trial in men and women who had taken glucocorticoids for 3 months or more prior to enrolment revealed that teriparatide had greater efficacy than the standard bisphosphonate alendronate in treating osteoporosis, said principal investigator Kenneth Saag, MD, MSc, Center for Education and Research on Therapeutics of Musculoskeletal Disorders, University of Alabama, Birmingham, Alabama.

Dr. Saag and colleagues randomised 214 patients to receive teriparatide 20 mcg daily and 214 to receive alendronate 10 mg daily.

Data from the first 18 months of the study were published in the New England Journal of Medicine in 2007 (Saag KG et al. 2007;357:2028-2039). The 36-month data were presented at an oral session on September 14.

Results at 36 months showed that teriparatide increased BMD and decreased new vertebral fractures, Dr. Saag commented in an interview.

At study entry, patients took a median dose of 7.5 mg daily of corticosteroids. Mean lumbar spine BMD T-scores were -2.4 in the teriparatide arm and -2.5 in the alendronate arm.

By 36 months, BMD at the lumbar spine was significantly higher in the teriparatide arm compared with the alendronate arm (mean change, 5.3% vs 11.0%; P < .001). Similarly, a substantially greater increase in BMD occurred at the femoral neck with teriparatide compared with alendronate (mean change, 3.4% vs 6.3%; P < .001).

Fewer patients in the teriparatide arm experienced new radiographic vertebral fractures compared with patients on alendronate (1.7% vs 7.7%; P = .007). The 2 arms had comparable rates of new nonvertebral fractures (7.5% vs 7.0%; P = .843).

The adverse effect profile of teriparatide was good, according to Dr. Saag. There was 1 case of hypercalcaemia reported in the teriparatide arm and no cases in the alendronate arm. "The rates of serum calcium were slightly higher in the teriparatide group," he said during the oral presentation, but stressed that there was not a significant difference in serum calcium levels between the 2 arms.

"The data suggest that teriparatide plays a role in treating high-risk patients," Dr. Saag said.

Funding for this study was provided by Eli Lilly and Company.

[Presentation title: Teriparatide Versus Alendronate for Treatment of Glucocorticoid-Induced Osteoporosis: 36-Month Results. Abstract 117]

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