Effects of teriparatide versus alendronate for treating glucocorticoid-induced osteoporosis: Thirty-six–month results of a randomized, double-blind, controlled trial

Authors

  • Kenneth G. Saag,

    Corresponding author
    1. University of Alabama at Birmingham
    • University of Alabama at Birmingham, FOT 820, 1530 Third Avenue South, Birmingham, AL 35294-3408
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    • Dr. Saag has received consulting and speaking fees from Novartis (more than $10,000) and from Eli Lilly, Merck, Amgen, Procter & Gamble, and Aventis (less than $10,000 each).

  • Jose R. Zanchetta,

    1. Universidad del Salvador, Buenos Aires, Argentina
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    • Dr. Zanchetta has received consulting and speaking fees from Amgen, Eli Lilly, Pfizer, and Servier (less than $10,000 each).

  • Jean-Pierre Devogelaer,

    1. Université Catholique de Louvain, Brussels, Belgium
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    • Dr. Devogelaer receives research support from Amgen, Eli Lilly, Merck, Nordic Bioscience, Novartis, Pfizer, Procter & Gamble, Sanofi-Aventis, Servier, and Wyeth and speaking fees from Eli Lilly, Novartis, Procter & Gamble, and Servier (less than $10,000 each).

  • Robert A. Adler,

    1. McGuire VAMC, Richmond, Virginia
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    • Dr. Adler has received speaking and consulting fees from Eli Lilly, Novartis, and Merck (less than $10,000 each), and research support from Eli Lilly, Novartis, and Procter & Gamble.

  • Richard Eastell,

    1. University of Sheffield, Sheffield, UK
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    • Dr. Eastell has received consulting or advisory board fees from Amgen, Novartis, Procter & Gamble, Servier, Ono, and GlaxoSmithKline (less than $10,000 each), lecture fees from Eli Lilly (less than $10,000), and grant support from AstraZeneca, Procter & Gamble, and Novartis (less than $10,000 each).

  • Kyoungah See,

    1. Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana
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    • Drs. See, Krege, Krohn, and Warner own stock or stock options in Eli Lilly.

  • John H. Krege,

    1. Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana
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    • Drs. See, Krege, Krohn, and Warner own stock or stock options in Eli Lilly.

  • Kelly Krohn,

    1. Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana
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    • Drs. See, Krege, Krohn, and Warner own stock or stock options in Eli Lilly.

  • Margaret R. Warner

    1. Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana
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    • Drs. See, Krege, Krohn, and Warner own stock or stock options in Eli Lilly.


  • ClinicalTrials.gov identifier: NCT00051558.

Abstract

Objective

To compare the bone anabolic drug teriparatide (20 μg/day) with the antiresorptive drug alendronate (10 mg/day) for treating glucocorticoid-induced osteoporosis (OP).

Methods

This was a 36-month, randomized, double-blind, controlled trial in 428 subjects with OP (ages 22–89 years) who had received ≥5 mg/day of prednisone equivalent for ≥3 months preceding screening. Measures included changes in lumbar spine and hip bone mineral density (BMD), changes in bone biomarkers, fracture incidence, and safety.

Results

Increases in BMD from baseline were significantly greater in the teriparatide group than in the alendronate group, and at 36 months were 11.0% versus 5.3% for lumbar spine, 5.2% versus 2.7% for total hip, and 6.3% versus 3.4% for femoral neck (P < 0.001 for all). In the teriparatide group, median percent increases from baseline in N-terminal type I procollagen propeptide (PINP) and osteocalcin (OC) levels were significant from 1 to 36 months (P < 0.01), and increases in levels of C-terminal telopeptide of type I collagen (CTX) were significant from 1 to 6 months (P < 0.01). In the alendronate group, median percent decreases in PINP, OC, and CTX were significant by 6 months and remained below baseline through 36 months (P < 0.001). Fewer subjects had vertebral fractures in the teriparatide group than in the alendronate group (3 [1.7%] of 173 versus 13 [7.7%] of 169; P = 0.007), with most occurring during the first 18 months. There was no significant difference between groups in the incidence of nonvertebral fractures (16 [7.5%] of 214 subjects taking teriparatide versus 15 [7.0%] of 214 subjects taking alendronate; P = 0.843). More subjects in the teriparatide group (21%) versus the alendronate group (7%) had elevated predose serum calcium concentrations (P < 0.001).

Conclusion

Our findings indicate that subjects with glucocorticoid-induced OP treated with teriparatide for 36 months had greater increases in BMD and fewer new vertebral fractures than subjects treated with alendronate.

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