Vitamin D status and response to treatment in post-menopausal osteoporosis
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Treatment with anti-resorptive agents over 13 months was associated with for three to fivefold lower bone mineral density changes and 1.5-fold increased risk of incidence fracture in vitamin D insufficient as compared to vitamin D repleted postmenopausal osteoporotic women.
Several drugs were registered for the treatment of osteoporosis on the basis of clinical trials in which vitamin D repletion was a pre-requisite inclusion criteria and vitamin D supplements were used as adjunctive therapy. However, in routine clinical practice these supplements are not consistently recommended.
We studied 1515 women with postmenopausal osteoporosis under treatment with anti-resorbing agents (alendronate, risedronate, raloxifene) for 13.1 months with an adherence > 75%. The patients were classified as vitamin D deficient (N = 514) or vitamin D repleted (N = 1001) according to risk factors (N = 1062) or the level of 25(OH) vitamin D [25(OH)D] above or below 50 nmol/l (N = 453).
Vitamin D deficient and vitamin D repleted subjects differed significantly for annualized spine and hip bone mineral density (BMD) changes adjusted for all available confounding factors (type of treatment, age, global calcium intake, baseline BMD values). One hundred fifty one patients suffered from a new incident clinical fracture. The adjusted odds ratio for incident fractures in vitamin D deficient as compared to vitamin D repleted women was 1.77 (1.20 – 2.59, 95% CI; p = 0.004).
Optimal vitamin D repletion seems to be necessary to maximize the response to anti-resorbers in terms of both BMD changes and anti-fracture efficacy.
KeywordsAlendronate BMD changes Fracture risk Osteoporosis treatment Risedronate Vitamin D deficiency
This study was supported by an unlimited grant from MSD Italia.
The following investigators participated in the data collection:
Antonino Catalano (Viterbo), Marco Cerilli (Roma), Domenico Castellino (Frosinone), Massimo Cravero and Gualtiero Grosso Roasenda (Torino), Maurizio Locati (Saronno), Andrea Tarroni (Rimini), Vanesa Germoni (Motta Di Livenza), Giuseppe Reina (Adrano), Michele Captano (Aversa), Alessandro Ragno (Albano Laziale), Angela Forlenza (Potenza), Giovanni Italiano (Caserta), Filippo Fantini (Frosinone), Ivana Santi (Milano), Baldassare Previti (Trapani), Sergio Gigliotti, Giusy Coppolino (Roma), Tommaso Giaccaglia (Jesi), Mario Barbagallo (Palermo), Edoardo Antonucci (Roma), Giovanni Iolascon (Napoli), Gerolamo Bianchi (Arenzano), Sandro Giannini (Padova), Maurizio Rossini (Verona), Stefano Savoca (Catania), Chiara Napoli (Catania), Ignazio Roberto Agnello (Palermo), Susanna Mosconi (Bergamo), Roberto Fiaschini (Fano), Maurizio Colonna (Torino), Tiziano Lusenti (Reggio Emilia), Daniela Bertolucci (Lido Di Camaiore), Claudio Dotta (Vittorio Veneto), Vincenzo Vinicola (Roma), Monica D’Adamo (Roma), Francesco Bertoldo (Verona), Vincenzo Maria Latte (Napoli), Bruno Seriolo (Genova), Gianluca Toraldo (Perugina), Bruno Frediani (Siena), Antonino Lasco (Messina), Giovanni Coppi (Roma), Fabio Massimo Ulivieri (Milano), Michele Calitro (Canosa), Cristina Limonta (Milano), Antonio Novello (Bari), Giangiacomo Osella (Orbassano), Mannarino C, Scarponi, Fabbriciani, Leli, Brozzetti, Callarelli (Perugia), Alfonso Balconcini (Arezzo), Maurizio Rondena (Legnano), Ruggero Spinazzè (Conegliano), Siro Grassi (Napoli), Silvana Crafa (Taranto), Sabrina Cerci (Frascati), Beatrice Fruttero, (Savigliano), Lucio Privitelli (Catania), Antonio Vitale (Napoli), Dario Bruno (Palermo), Massimo D’amore (Bari), Enrico Cacace (Monserrato), Francesca Colapietro (Roma), Annalisa Cagnana (Cinisello Balsamo), Carmelina Bosa (S. Angelo Lodigiano), Franco De Michele (Martina Franca), Domenico La Malfa, Massimo Procopio (Torino), Michele Lunetta (Caltanissetta), Antonella Grazioli, (Caserta), Matteo Colina Ferrara, Andrea Delle Sedie (Pisa), Annamaria Nuzzi (Alba), Clemente Napoletano (Latina).
Conflicts of interest
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