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01-12-2019 | Bisphosphonate | Short Scientific Communication

Serum 25-hydroxy-vitamin D and the risk of fractures in the teriparatide versus risedronate VERO clinical trial

Authors: Salvatore Minisola, Fernando Marin, David L. Kendler, Piet Geusens, Cristiano A. F. Zerbini, Luis A. Russo, Enrique Casado, Astrid Fahrleitner-Pammer, Jan J. Stepan, Eric Lespessailles, Rüdiger Moericke, Alicia Bagur, Péter Lakatos, Pedro López-Romero, Jean Jacques Body

Published in: Archives of Osteoporosis | Issue 1/2019

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

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Title: Serum 25-hydroxy-vitamin D and the risk of fractures in the teriparatide versus risedronate VERO clinical trial
Authors: Salvatore Minisola
Fernando Marin
David L. Kendler
Piet Geusens
Cristiano A. F. Zerbini
Luis A. Russo
Enrique Casado
Astrid Fahrleitner-Pammer
Jan J. Stepan
Eric Lespessailles
Rüdiger Moericke
Alicia Bagur
Péter Lakatos
Pedro López-Romero
Jean Jacques Body
Publication date: 01-12-2019
Publisher: Springer London
Keywords: Bisphosphonate
Osteoporosis
Osteoporosis
Published in: Archives of Osteoporosis / Issue 1/2019
Print ISSN: 1862-3522
Electronic ISSN: 1862-3514
DOI: https://doi.org/10.1007/s11657-019-0561-x

At a glance: The STEP trials

Springer Medicine

Serum 25-hydroxy-vitamin D and the risk of fractures in the teriparatide versus risedronate VERO clinical trial

Abstract

Purpose

Methods

Results

Conclusions

Trial registration

At a glance: The STEP trials

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusions

Trial registration

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