Evidence map›Paper›PMID 38520382›Full record

Trial reportCancer2024

High-dose vitamin D to attenuate bone loss in patients with prostate cancer on androgen deprivation therapy: A phase 2 RCT.

Luke J Peppone, Amber S Kleckner, Chunkit Fung, J Edward Puzas, Jennifer E Reschke, Eva Culakova, Julia Inglis, Charles Kamen, Jonathan W Friedberg, Michelle Janelsins and 3 more

Open access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
3.1field-weighted citation impact, top 7% 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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Bone health in patients with cancer: a SEOM-SEIOMM consensus review of risk factors, assessment strategies, and management approaches.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
  3. Review
  4. Article
  5. Proactive strategies for fracture risk in androgen deprivation therapy: a call for multidisciplinary collaboration.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2025
    Article
  6. Review
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 3 institutions in 1 country.

Luke J PepponeDepartment of Surgery, Division of Supportive Care in Cancer, University of Rochester Medical Center, Rochester, New York, USA.ORCID https://orcid.org/0000-0002-0346-5191
Amber S KlecknerSchool of Nursing, University of Maryland, Baltimore, Maryland, USA.
Chunkit FungDepartment of Medicine, University of Rochester Medical Center, Rochester, New York, USA.
J Edward PuzasDepartment of Orthopaedics, University of Rochester Medical Center, Rochester, New York, USA.
Jennifer E ReschkeDepartment of Surgery, Division of Supportive Care in Cancer, University of Rochester Medical Center, Rochester, New York, USA.
Eva CulakovaDepartment of Surgery, Division of Supportive Care in Cancer, University of Rochester Medical Center, Rochester, New York, USA.
Julia InglisSchool of Health Sciences, Liberty University, Charlottesville, Virginia, USA.
Charles KamenDepartment of Surgery, Division of Supportive Care in Cancer, University of Rochester Medical Center, Rochester, New York, USA.ORCID https://orcid.org/0000-0002-4219-4320
Jonathan W FriedbergDepartment of Medicine, University of Rochester Medical Center, Rochester, New York, USA.
Michelle JanelsinsDepartment of Surgery, Division of Supportive Care in Cancer, University of Rochester Medical Center, Rochester, New York, USA.
Karen MustianDepartment of Surgery, Division of Supportive Care in Cancer, University of Rochester Medical Center, Rochester, New York, USA.
Charles E HecklerDepartment of Surgery, Division of Supportive Care in Cancer, University of Rochester Medical Center, Rochester, New York, USA.
Supriya MohileDepartment of Medicine, University of Rochester Medical Center, Rochester, New York, USA.
University of Rochester Medical Center · USUniversity of Maryland, Baltimore · USUniversity of Virginia Health System · US

Funding

URCC NCORP Research BaseUG1CA189961 · NCI · UNIVERSITY OF ROCHESTER · PI Michelle C Janelsins, KAREN M. MUSTIAN · 2014 to 2026
$67.7M
Clinical and Translational Cancer Control Research Training ProgramT32CA102618 · NCI · UNIVERSITY OF ROCHESTER · PI Michelle C Janelsins, Gary R Morrow · 2019 to 2026
$2.7M
A Patient-Oriented Research Program in Geriatric OncologyK24AG056589 · NIA · UNIVERSITY OF ROCHESTER · PI Supriya G. Mohile · 2018 to 2026
$1.5M
RCT for Mechanisms and Management of Sleep Utilizing Multicenter Clinical Oncology NetworkR21CA185678 · NCI · STANFORD UNIVERSITY · PI MUSTIAN, KAREN M., PALESH, OXANA G · 2015 to 2016
$381k
NCI NIH HHS R21 CA185678NCI NIH HHS R21CA185678NCI NIH HHS T32 CA102618NCI NIH HHS T32CA102618NCI NIH HHS UG1 CA189961NCI NIH HHS UG1CA189961NIA NIH HHS K24 AG056589
6 · The paper itself

Abstract

backgroundAndrogen deprivation therapy (ADT) inhibits prostate cancer growth. However, ADT causes loss of bone mineral density (BMD) and an increase in fracture risk; effective interventions for ADT-induced bone loss are limited.

methodsA phase 2 randomized controlled trial investigated the feasibility, safety, and preliminary efficacy of high-dose weekly vitamin D (HDVD, 50,000 IU/week) versus placebo for 24 weeks in patients with prostate cancer receiving ADT, with all subjects receiving 600 IU/day vitamin D and 1000 mg/day calcium. Participants were ≥60 years (mean years, 67.7), had a serum 25-hydroxyvitamin D level <32 ng/mL, and initiated ADT within the previous 6 months. At baseline and after intervention, dual-energy x-ray absorptiometry was used to assess BMD, and levels of bone cell, bone formation, and resorption were measured.

resultsThe HDVD group (N = 29) lost 1.5% BMD at the total hip vs. 4.1% for the low-dose group (N = 30; p = .03) and 1.7% BMD at the femoral neck vs. 4.4% in the low-dose group (p = .06). Stratified analyses showed that, for those with baseline 25-hydroxyvitamin D level <27 ng/mL, the HDVD group lost 2.3% BMD at the total hip vs 7.1% for the low-dose group (p < .01). Those in the HDVD arm showed significant changes in parathyroid hormone (p < .01), osteoprotegerin (p < 0.01), N-terminal telopeptide of type 1 collagen (p < 0.01) and C-terminal telopeptide of type 1 collagen (p < 0.01). No difference in adverse events or toxicity was noted between the groups.

conclusionsHDVD supplementation significantly reduced hip and femoral neck BMD loss, especially for patients with low baseline serum 25-hydroxyvitamin D levels, although demonstrating safety and feasibility in prostate cancer patients on ADT.

Indexed as

Androgen AntagonistsBone DensityProstatic NeoplasmsVitamin DAgedHumansMaleMiddle AgedOsteoporosis25-hydroxyvitamin DAndrogen AntagonistsVitamin Dadverse effectshormonal therapyosteoporosisprostatic neoplasmsvitamin Dvitamins

Identifiers

PMID38520382
PMCPMC11214601
OpenAlexW4393119467

What Socratic holds

Textmetadata
LicenceTDM
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 Socratic graph.