Evidence map›Paper›PMID 23208074›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 USA2013

Health risks and benefits from calcium and vitamin D supplementation: Women's Health Initiative clinical trial and cohort study.

R L Prentice, M B Pettinger, R D Jackson, J Wactawski-Wende, A Z Lacroix, G L Anderson, R T Chlebowski, J E Manson, L Van Horn, M Z Vitolins and 4 more

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
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, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02186600 (Randomized Control Trial of Bone Loading Exercises Versus Risedronate on Bone Health in Post-Menopausal Women), which is not on this map. Cited by 122 papers, 18 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
122citing papers in PubMed, 18 pooled it
19.6field-weighted citation impact, top 1% 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.

NCT02186600 phase3completednot on this mapstarted 2015, after this paper: background citation

Randomized Control Trial of Bone Loading Exercises Versus Risedronate on Bone Health in Post-Menopausal Women

TypeinterventionalSponsorUniversity of NebraskaRan2015 to 2019Enrolled276ConditionsOsteopeniaArmsCalcium Carbonate, Vitamin D3, Risedronate, Bone-loading exercises
3 · Its place in the literature

Who cites it

122 citing papers in PubMed, 18 syntheses or guidelines pooled it, 293 citations in OpenAlex.

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  14. Atencion primaria · 2018
    Guideline
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  16. Calcium plus vitamin D supplementation and risk of fractures: an updated meta-analysis from the National Osteoporosis Foundation.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2016
    Pooled it
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  18. Clinician's Guide to Prevention and Treatment of Osteoporosis.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2014
    Guideline
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  20. Trial

62 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 11 institutions in 2 countries.

R L PrenticePublic Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109-1024, USA. rprentic@whi.org
M B Pettinger
R D Jackson
J Wactawski-Wende
A Z Lacroix
G L Anderson
R T Chlebowski
J E Manson
L Van Horn
M Z Vitolins
M Datta
E S LeBlanc
J A Cauley
J E Rossouw
Fred Hutch Cancer Center · USWake Forest University · USBrigham and Women's Hospital · USCape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa · ZAHarbor–UCLA Medical Center · USKaiser Permanente Center for Health Research · USNational Heart Lung and Blood Institute · USNorthwestern University · USThe Ohio State University · USUniversity at Buffalo, State University of New York · USUniversity of Pittsburgh · US

Funding

Nutrition and Physical Activity Assessment Study (NPAAS)R01CA119171 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Marian L Neuhouser · 2006 to 2026
$14.3M
Use of Biomarkers in Diagnosis, Prognosis, Risk Prediction and Early Detection ofP01CA053996 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI PRENTICE, ROSS L · 1991 to 2015
$9.4M
Postdoctoral Training Program in Cancer SurvivorshipR25CA122061 · NCI · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI AVIS, NANCY E · 2008 to 2018
$3.8M
Women's Health Initiative Memory Study (WHIMS)N01WH44221 · WH · WAKE FOREST UNIVERSITY HEALTH SCIENCES · 2009 to 2010
$3.1M
CLIN CTR CLIN TRIAL/OBSERVATIONAL STUDY OF WHIN01WH042119 · WH · YESHIVA UNIVERSITY · PI WASSERTHEIL-SMOLLER, SYLVIA · 1994 to 2001
$2.2M
VANGUARD CENTER FOR WOMEN'S HEALTH INITIATIVEN01WH032111 · WH · EMORY UNIVERSITY · PI WATTS, NELSON · 1993 to 2001
$1.6M
CLIN CTR CLIN TRIAL/OBSERVATIONAL STUDY OF WHIN01WH042123 · WH · MEDSTAR RESEARCH INSTITUTE · PI HOWARD, BARBARA V · 1994 to 2000
$1.4M
CLIN CTR CLIN TRIAL/OBSERVATIONAL STUDY OF WHIN01WH042109 · WH · STANFORD UNIVERSITY · PI STEFANICK, MARCIA L · 1994 to 2000
$1.4M
CLIN CTR CLIN TRIAL/OBSERVATIONAL STUDY OF WHIN01WH042114 · WH · KAISER FOUNDATION RESEARCH INSTITUTE · PI RITENBAUGH, CHERYL K · 1994 to 2000
$1.4M
CLIN CTR CLIN TRIAL/OBSERVATIONAL STUDY OF WHIN01WH042108 · WH · GEORGE WASHINGTON UNIVERSITY · PI HSIA, JUDITH · 1994 to 2000
$1.4M
CLIN CTR CLIN TRIAL/OBSERVATIONAL STUDY OF WHIN01WH042124 · WH · RUSH UNIVERSITY MEDICAL CENTER · PI BLACK, HENRY R · 1994 to 2000
$1.4M
CLIN CTR CLIN TRIAL/OBSERVATIONAL STUDY OF WHIN01WH042131 · WH · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI O'SULLIVAN, MARY J · 1994 to 2000
$1.3M
NCI NIH HHS CA53996NCI NIH HHS P01 CA053996NCI NIH HHS R01 CA119171NCI NIH HHS R25 CA122061PHS HHS 24152PHS HHS 32100PHS HHS 32101PHS HHS 32102PHS HHS 32105PHS HHS 32108WHI NIH HHS N01 WH022110WHI NIH HHS N01WH32109WHI NIH HHS N01WH32111WHI NIH HHS N01WH32112WHI NIH HHS N01WH32113WHI NIH HHS N01WH32115WHI NIH HHS N01WH32118WHI NIH HHS N01WH32119WHI NIH HHS N01WH32122WHI NIH HHS N01WH42107WHI NIH HHS N01WH42108WHI NIH HHS N01WH42109WHI NIH HHS N01WH42110WHI NIH HHS N01WH42111WHI NIH HHS N01WH42112WHI NIH HHS N01WH42113WHI NIH HHS N01WH42114WHI NIH HHS N01WH42115WHI NIH HHS N01WH42116WHI NIH HHS N01WH42117WHI NIH HHS N01WH42118WHI NIH HHS N01WH42119WHI NIH HHS N01WH42120WHI NIH HHS N01WH42121WHI NIH HHS N01WH42122WHI NIH HHS N01WH42123WHI NIH HHS N01WH42124WHI NIH HHS N01WH42125WHI NIH HHS N01WH42126WHI NIH HHS N01WH42129WHI NIH HHS N01WH42130WHI NIH HHS N01WH42131WHI NIH HHS N01WH42132WHI NIH HHS N01WH44221
6 · The paper itself

Abstract

summaryThe Women's Health Initiative (WHI) double-blind, placebo-controlled clinical trial randomly assigned 36,282 postmenopausal women in the U.S. to 1,000 mg elemental calcium carbonate plus 400 IU of vitamin D(3) daily or placebo, with average intervention period of 7.0 years. The trial was designed to test whether calcium plus vitamin D supplementation in a population in which the use of these supplements was widespread would reduce hip fracture, and secondarily, total fracture and colorectal cancer.

introductionThis study further examines the health benefits and risks of calcium and vitamin D supplementation using WHI data, with emphasis on fractures, cardiovascular disease, cancer, and total mortality.

methodsWHI calcium and vitamin D randomized clinical trial (CT) data through the end of the intervention period were further analyzed with emphasis on treatment effects in relation to duration of supplementation, and these data were contrasted and combined with corresponding data from the WHI prospective observational study (OS).

resultsAmong women not taking personal calcium or vitamin D supplements at baseline, the hazard ratio [HR] for hip fracture occurrence in the CT following 5 or more years of calcium and vitamin D supplementation versus placebo was 0.62 (95 % confidence interval (CI), 0.38-1.00). In combined analyses of CT and OS data, the corresponding HR was 0.65 (95 % CI, 0.44-0.98). Supplementation effects were not apparent on the risks of myocardial infarction, coronary heart disease, total heart disease, stroke, overall cardiovascular disease, colorectal cancer, or total mortality, while evidence for a reduction in breast cancer risk and total invasive cancer risk among calcium plus vitamin D users was only suggestive.

conclusionThough based primarily on a subset analysis, long-term use of calcium and vitamin D appears to confer a reduction that may be substantial in the risk of hip fracture among postmenopausal women. Other health benefits and risks of supplementation at doses considered, including an elevation in urinary tract stone formation, appear to be modest and approximately balanced.

Indexed as

AgedBone Density Conservation AgentsCalcium CarbonateCardiovascular DiseasesCholecalciferolDietary SupplementsDouble-Blind MethodDrug Administration ScheduleDrug Therapy, CombinationFemaleHip FracturesHumansMiddle AgedNeoplasmsOsteoporosis, PostmenopausalOsteoporotic FracturesBone Density Conservation AgentsCalcium CarbonateCholecalciferol

Identifiers

PMID23208074
PMCPMC3557387
OpenAlexW2009142498

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Registered trials

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.