Vitamin D Status in Paget Disease of Bone and Efficacy–Safety Profile of Cholecalciferol Treatment in Pagetic Patients with Hypovitaminosis D
Adequate vitamin D status is essential for skeletal health. Paget’s disease of bone (PDB) is a common metabolic skeletal disorder, but data regarding the vitamin D status in PDB patients are lacking. We performed a case–control study to estimate vitamin D status in 708 PDB patients and in 1803 healthy controls from Italy and an observational prospective study to evaluate the efficacy–safety profile of oral cholecalciferol treatment [400.000 International Units (UI) of cholecalciferol administered in cycles of 8 weeks until 25OHD levels reaches 70 nmol/L as primary therapy and 50.000 UI of cholecalciferol administered every 2 weeks for 52 weeks for the maintenance therapy] in 82 PDB patients with hypovitaminosis D, i.e., 25OHD < 50 nmol/L. The main outcome measures for the prospective study were 25OHD levels, metabolic risk factors (RF) for nephrolithiasis, bone pain score (BPS), and pain medication score (PMS). Over half of PDB patients had hypovitaminosis D. Among PDB patients treated with cholecalciferol, 76 patients reached 25OHD levels ≥ 70 nmol/L after the first cycle of primary therapy and the remaining six patients after a second cycle. The maintenance therapy guaranteed 25OHD levels ≥ 70 nmol/L during the entire follow-up. The increase in 25OHD levels reduced PTH, BPS, and PMS levels, without changes in RF for nephrolithiasis. We can conclude that (i) hypovitaminosis D is frequent in PDB patients, (ii) cholecalciferol significantly increased 25OHD levels in PDB patients, and (iii) the correction of hypovitaminosis D improves the quality of life of PDB patients without inducing significant changes in RF for nephrolithiasis.
KeywordsPaget’s disease of bone Cholecalciferol 25OHD Hypovitaminosis D Efficacy Safety
DR designed the study and prepared the first draft of the paper. He is guarantor. GDF, DM, MDS, MS, SMM, SB, EC, RF, RN, PS, and LG contributed to the experimental work. LD’E was responsible for statistical analysis of the data.
This research did not receive any specific grant from any funding agency in the public, commercial, or not-for-profit sector.
Compliance with Ethical Standards
Conflict of interest
Domenico Rendina, Gianpaolo De Filippo, Daniela Merlotti, Marco Di Stefano, Mariangela Succoio, Simona Maria Muggianu, Simone Bianciardi, Lanfranco D’Elia, Eleonora Coppo, Raffaella Faraonio, Ranuccio Nuti, Pasquale Strazzullo, and Luigi Gennari declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported.
All procedures performed in this study, which involves human participants, were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Human and Animal Rights and Informed Consent
Written informed consent has been obtained from each patient or subject after full explanation of the purpose and nature of all used procedures. The study protocol was approved by the Federico II University Ethical Committee.
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