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Serum 25-hydroxy-vitamin D and the risk of fractures in the teriparatide versus risedronate VERO clinical trial.
Arch Osteoporos. 2019 01 18; 14(1):10.AO

Abstract

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.

Authors+Show Affiliations

Department of Internal Medicine and Medical Disciplines, Sapienza Rome University, Viale del Policlinico 151, 00161, Rome, Italy. salvatore.minisola@uniroma1.it.Lilly Research Center Europe, Madrid, Spain.University of British Columbia, Vancouver, Canada.Maastricht University Medical Center, Maastricht, The Netherlands.Centro Paulista de Investigaçao Clínica, Sao Paulo, Brazil.Centro de Analises e Pesquisas Clínicas LTDA, Rio de Janeiro, Brazil.University Hospital Parc Taulí Sabadell (UAB), Barcelona, Spain.Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria.Institute of Rheumatology and Faculty of Medicine 1, Charles University, Prague, Czech Republic.Regional Hospital, University of Orleans, Orleans, France.Institut Präventive Medizin & Klinische Forschung, Magdeburg, Germany.Centro de Osteopatías Comlit, Buenos Aires, Argentina.Semmelweis University Medical School, Budapest, Hungary.Lilly Research Center Europe, Madrid, Spain.CHU Brugmann, ULB, Brussels, Belgium.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

30659410

Citation

Minisola, Salvatore, et al. "Serum 25-hydroxy-vitamin D and the Risk of Fractures in the Teriparatide Versus Risedronate VERO Clinical Trial." Archives of Osteoporosis, vol. 14, no. 1, 2019, p. 10.
Minisola S, Marin F, Kendler DL, et al. Serum 25-hydroxy-vitamin D and the risk of fractures in the teriparatide versus risedronate VERO clinical trial. Arch Osteoporos. 2019;14(1):10.
Minisola, S., Marin, F., Kendler, D. L., Geusens, P., Zerbini, C. A. F., Russo, L. A., Casado, E., Fahrleitner-Pammer, A., Stepan, J. J., Lespessailles, E., Moericke, R., Bagur, A., Lakatos, P., López-Romero, P., & Body, J. J. (2019). Serum 25-hydroxy-vitamin D and the risk of fractures in the teriparatide versus risedronate VERO clinical trial. Archives of Osteoporosis, 14(1), 10. https://doi.org/10.1007/s11657-019-0561-x
Minisola S, et al. Serum 25-hydroxy-vitamin D and the Risk of Fractures in the Teriparatide Versus Risedronate VERO Clinical Trial. Arch Osteoporos. 2019 01 18;14(1):10. PubMed PMID: 30659410.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Serum 25-hydroxy-vitamin D and the risk of fractures in the teriparatide versus risedronate VERO clinical trial. AU - Minisola,Salvatore, AU - Marin,Fernando, AU - Kendler,David L, AU - Geusens,Piet, AU - Zerbini,Cristiano A F, AU - Russo,Luis A, AU - Casado,Enrique, AU - Fahrleitner-Pammer,Astrid, AU - Stepan,Jan J, AU - Lespessailles,Eric, AU - Moericke,Rüdiger, AU - Bagur,Alicia, AU - Lakatos,Péter, AU - López-Romero,Pedro, AU - Body,Jean Jacques, Y1 - 2019/01/18/ PY - 2018/08/28/received PY - 2019/01/07/accepted PY - 2019/1/20/entrez PY - 2019/1/20/pubmed PY - 2020/2/18/medline KW - 25-Hydroxy-vitamin D KW - Bisphosphonates KW - Fractures KW - Postmenopausal osteoporosis KW - Subgroup analysis KW - Teriparatide SP - 10 EP - 10 JF - Archives of osteoporosis JO - Arch Osteoporos VL - 14 IS - 1 N2 - 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. SN - 1862-3514 UR - https://www.unboundmedicine.com/medline/citation/30659410/Serum_25_hydroxy_vitamin_D_and_the_risk_of_fractures_in_the_teriparatide_versus_risedronate_VERO_clinical_trial_ L2 - https://dx.doi.org/10.1007/s11657-019-0561-x DB - PRIME DP - Unbound Medicine ER -