PURPOSE: Using data from the 2-year, randomized, double-dummy VERO trial, we examined the changes in 25-hydroxy-vitamin D (25[OH]D) concentrations over time, and whether the fracture risk reduction of teriparatide versus risedronate varies by baseline 25(OH)D sufficiency category. METHODS: Postmenopausal women with established osteoporosis received subcutaneous daily teriparatide 20 μg or oral weekly risedronate 35 mg, with concomitant 500-1000 mg of elemental calcium and 400-800 IU/day of vitamin D supplements. Fracture endpoints were analyzed by predefined subgroups of 25(OH)D insufficient and sufficient patients. Heterogeneity of the treatment effect on fractures was investigated by logistic and Cox proportional hazards regression models. RESULTS: At baseline, mean serum 25(OH)D was 31.9 ng/mL in the teriparatide group and 31.5 ng/mL in the risedronate group, and 16.8% and 17.9% of patients, respectively, were 25(OH)D insufficient. At month 6, the mean serum 25(OH)D concentration decreased in teriparatide-treated patients to 24.5 ng/mL (by approximately 23%) but remained relatively constant in risedronate-treated patients (32.2 ng/mL) (p < 0.001). Proportions of 25(OH)D insufficient patients at month 6 were 26.7% and 5.6%, respectively (p < 0.001). The risk reduction with teriparatide versus risedronate for any of the fracture endpoints did not significantly differ between subgroups by 25(OH)D sufficiency status at baseline, with nonsignificant (p > 0.1) treatment-by-25(OH)D interactions in all fracture analyses. CONCLUSIONS: Serum 25(OH)D concentration decreases during teriparatide treatment. Fracture risk reduction with teriparatide versus risedronate did not significantly differ between the two groups of patients defined by baseline 25(OH)D. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01709110 EudraCT Number: 2012-000123-41.

Centro de Analises e Pesquisas Clínicas LTDA Rio de Janeiro Brazil

Centro de Osteopatías Comlit Buenos Aires Argentina

Centro Paulista de Investigaçao Clínica Sao Paulo Brazil

CHU Brugmann ULB Brussels Belgium

Department of Internal Medicine and Medical Disciplines Sapienza Rome University Viale del Policlinico 151 00161 Rome Italy

Division of Endocrinology and Diabetology Medical University of Graz Graz Austria

Institut Präventive Medizin and Klinische Forschung Magdeburg Germany

Institute of Rheumatology and Faculty of Medicine 1 Charles University Prague Czech Republic

Lilly Research Center Europe Madrid Spain

Maastricht University Medical Center Maastricht The Netherlands

Regional Hospital University of Orleans Orleans France

Semmelweis University Medical School Budapest Hungary

University Hospital Parc Taulí Sabadell Barcelona Spain

University of British Columbia Vancouver Canada

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Decrease in serum calcitriol (but not free 25-hydroxyvitamin D) concentration in hip fracture healing

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ClinicalTrials.gov
NCT01709110