BACKGROUND: Intermittent administration of teriparatide, a drug composed of the first 34 amino acids of parathyroid hormone, has anabolic effects on bone. Although teriparatide has been evaluated for the treatment of osteoporosis and for the healing of fractures, clinical trials evaluating it for the treatment of osseous conditions of the oral cavity in humans are lacking. METHODS: A total of 40 patients with severe, chronic periodontitis underwent periodontal surgery and receiveddaily injections of teriparatide (20 μg) or placebo, along with oral calcium (1000 mg) and vitamin D (800 IU) supplementation, for 6 weeks. The patients were followed for 1 year. The primary outcome was a radiographic linear measurement of alveolar bone level. Secondary outcomes included clinical variables, bone turnover markers in serum and oral fluid, systemic bone mineral density, and quality of life. RESULTS:Radiographic linear resolution of osseous defects was significantly greater after teriparatide therapy than after placebo beginning at 6 months, with a mean linear gain in bone at 1 year of 29% as compared with 3% (P<0.001). Clinical improvement was greater in patients taking teriparatide than in those taking placebo, with a reduction in periodontal probing depth of 33% versus 20% (2.42 mm vs. 1.32 mm) and a gain in clinical attachment level of 22% versus 7% (1.58 mm vs. 0.42 mm) in target lesions at 1 year (P = 0.02 for both comparisons). No serious adverse events were reported; however, the number of patients in the study was small. No significant differences were noted with respect to the other variables that were assessed. CONCLUSIONS:Teriparatide, as compared with placebo, was associated with improved clinical outcomes, greater resolution of alveolar bone defects, and accelerated osseous wound healing in the oral cavity. Teriparatide may offer therapeutic potential for localized bone defects in the jaw. (Funded by the National Institutes of Health and others; ClinicalTrials.gov number, NCT00277706 .).
RCT Entities:
BACKGROUND: Intermittent administration of teriparatide, a drug composed of the first 34 amino acids of parathyroid hormone, has anabolic effects on bone. Although teriparatide has been evaluated for the treatment of osteoporosis and for the healing of fractures, clinical trials evaluating it for the treatment of osseous conditions of the oral cavity in humans are lacking. METHODS: A total of 40 patients with severe, chronic periodontitis underwent periodontal surgery and received daily injections of teriparatide (20 μg) or placebo, along with oral calcium (1000 mg) and vitamin D (800 IU) supplementation, for 6 weeks. The patients were followed for 1 year. The primary outcome was a radiographic linear measurement of alveolar bone level. Secondary outcomes included clinical variables, bone turnover markers in serum and oral fluid, systemic bone mineral density, and quality of life. RESULTS: Radiographic linear resolution of osseous defects was significantly greater after teriparatide therapy than after placebo beginning at 6 months, with a mean linear gain in bone at 1 year of 29% as compared with 3% (P<0.001). Clinical improvement was greater in patients taking teriparatide than in those taking placebo, with a reduction in periodontal probing depth of 33% versus 20% (2.42 mm vs. 1.32 mm) and a gain in clinical attachment level of 22% versus 7% (1.58 mm vs. 0.42 mm) in target lesions at 1 year (P = 0.02 for both comparisons). No serious adverse events were reported; however, the number of patients in the study was small. No significant differences were noted with respect to the other variables that were assessed. CONCLUSIONS:Teriparatide, as compared with placebo, was associated with improved clinical outcomes, greater resolution of alveolar bone defects, and accelerated osseous wound healing in the oral cavity. Teriparatide may offer therapeutic potential for localized bone defects in the jaw. (Funded by the National Institutes of Health and others; ClinicalTrials.gov number, NCT00277706 .).
Authors: Myron Nevins; William V Giannobile; Michael K McGuire; Richard T Kao; James T Mellonig; James E Hinrichs; Bradley S McAllister; Kevin S Murphy; Pamela K McClain; Marc L Nevins; David W Paquette; Thomas J Han; Michael S Reddy; Philip T Lavin; Robert J Genco; Samuel E Lynch Journal: J Periodontol Date: 2005-12 Impact factor: 6.993
Authors: Per Aspenberg; Harry K Genant; Torsten Johansson; Antonio J Nino; Kyoungah See; Kelly Krohn; Pedro A García-Hernández; Christopher P Recknor; Thomas A Einhorn; Gail P Dalsky; Bruce H Mitlak; Anke Fierlinger; Mark C Lakshmanan Journal: J Bone Miner Res Date: 2010-02 Impact factor: 6.741
Authors: Glenda J Pettway; Jeffrey A Meganck; Amy J Koh; Evan T Keller; Steven A Goldstein; Laurie K McCauley Journal: Bone Date: 2007-12-15 Impact factor: 4.398
Authors: W V Giannobile; S E Lynch; R G Denmark; D W Paquette; J P Fiorellini; R C Williams Journal: J Clin Periodontol Date: 1995-12 Impact factor: 8.728
Authors: Chad M Novince; Megan N Michalski; Amy J Koh; Benjamin P Sinder; Payam Entezami; Matthew R Eber; Glenda J Pettway; Thomas J Rosol; Thomas J Wronski; Ken M Kozloff; Laurie K McCauley Journal: J Bone Miner Res Date: 2012-01 Impact factor: 6.741