Evidence map›Paper›PMID 28815282›Full record

Trial reportOsteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA2017

Correction of vitamin D status by calcidiol: pharmacokinetic profile, safety, and biochemical effects on bone and mineral metabolism of daily and weekly dosage regimens.

S Minisola, L Cianferotti, P Biondi, C Cipriani, C Fossi, F Franceschelli, F Giusti, G Leoncini, J Pepe, H A Bischoff-Ferrari and 1 more

Open access · greenAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 3 pooled it
2.4field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 3 syntheses or guidelines pooled it, 41 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Trial
  5. Calcifediol is superior to cholecalciferol in improving vitamin D status in postmenopausal women: a randomized trial.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2021
    Trial
  6. Trial
  7. Article
  8. Review
  9. Too much vitamin D? a drug safety review.Reviews in endocrine & metabolic disorders · 2026
    Review
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Hormones and Aging: An Endocrine Society Scientific Statement.The Journal of clinical endocrinology and metabolism · 2023
    Article
  19. Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 2 countries.

S MinisolaDepartment of Internal Medicine and Medical Disciplines, "Sapienza", University of Rome, Rome, Italy.
L CianferottiMetabolic Bone Diseases Unit, Department of Surgery and Translational Medicine, University of Florence, Florence, Italy.
P BiondiDepartment of Internal Medicine and Medical Disciplines, "Sapienza", University of Rome, Rome, Italy.
C CiprianiDepartment of Internal Medicine and Medical Disciplines, "Sapienza", University of Rome, Rome, Italy.
C FossiMetabolic Bone Diseases Unit, Department of Surgery and Translational Medicine, University of Florence, Florence, Italy.
F FranceschelliMetabolic Bone Diseases Unit, Department of Surgery and Translational Medicine, University of Florence, Florence, Italy.
F GiustiMetabolic Bone Diseases Unit, Department of Surgery and Translational Medicine, University of Florence, Florence, Italy.
G LeonciniMetabolic Bone Diseases Unit, Department of Surgery and Translational Medicine, University of Florence, Florence, Italy.
J PepeDepartment of Internal Medicine and Medical Disciplines, "Sapienza", University of Rome, Rome, Italy.
H A Bischoff-FerrariDepartment of Geriatrics and Aging Research, University Hospital and University of Zurich, Zürich, Switzerland.
M L BrandiMetabolic Bone Diseases Unit, Department of Surgery and Translational Medicine, University of Florence, Florence, Italy. marialuisa.brandi@unifi.it.
University of Florence · ITSapienza University of Rome · ITUniversity of Zurich · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

rationaleCalcidiol can be employed to correct vitamin D deficiency. MAIN

resultsCalcidiol administered at daily and weekly regimens over a period of 3 months was able to successfully raise 25-hydroxyvitamin D levels without altering other markers related to bone and mineral metabolism. SIGNIFICANCE: Calcidiol supplementation is effective and safe.

introductionThe correction of vitamin D status is necessary to maintain an optimal mineral and skeletal homeostasis. Despite cholecalciferol (vitamin D

methodsA total of 87 Caucasian, community-dwelling, postmenopausal women, aged 55 years or older, with vitamin D inadequacy (serum 25(OH)D levels <30 ng/ml, with mean 25(OH)D below 20 ng/ml, namely 16.5 ± 7.5 ng/ml) were randomized to receive three different dosages of calcidiol: 20 μg/day, 40 μg/day, and 125 μg/week for 3 months. The attained level of serum 25(OH)D was selected as primary endpoint to assess efficacy, while other parameters of mineral metabolism, (serum calcium, parathyroid hormone, phosphate, FGF23, urinary calcium, and markers of bone turnover) were assessed as secondary endpoints to establish safety.

resultsIn all the three groups, serum 25(OH)D values significantly and promptly rose and plateaued above the 30 ng/ml threshold remaining within safety interval after 14 days of treatment, with similar efficacy for the similar daily and weekly dose regimens. The different dosages were also equally effective in controlling secondary hyperparathyroidism. No significant changes in calcium and phosphate metabolism and in bone turnover markers were observed for any of the treatments, confirming the safety of this compound.

conclusionsThe results of this study demonstrate the short- and mid-term efficacy and safety on core parameters of mineral metabolism of different daily or weekly dosages of calcidiol when used to treat vitamin D inadequacy or deficiency in postmenopausal women. Further studies are needed to assess falls as primary outcome of calcidiol supplementation.

Indexed as

BiomarkersBone and BonesBone Density Conservation AgentsBone RemodelingCalcifediolCalciumDose-Response Relationship, DrugDrug Administration ScheduleFemaleFibroblast Growth Factor-23HumansMiddle AgedPhosphatesPostmenopauseVitamin DVitamin D Deficiency25-hydroxyvitamin DBiomarkersBone Density Conservation AgentsCalcifediolCalciumFGF23 protein, humanFibroblast Growth Factor-23PhosphatesVitamin DFractureHypovitaminosis DOsteomalaciaOsteoporosisRicketsVitamin D deficiency

Identifiers

PMID28815282
OpenAlexW2749816574

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.