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CME

Calcium and Vitamin D for Treatment and Prevention of Osteoporosis

General Information

Description

Definitions

  • osteoporosis - generalized skeletal disorder characterized by low bone density, deterioration of bone quality, and compromised bone strength, often leading to fragility fracture due to excessive bone loading from a fall or certain activities of daily living (mnh25182228pcxh98520295pmdc25182228pOsteoporos Int 2014 Oct;25(10):2359)
  • Recommended Dietary Allowance (RDA) - intake expected to meet requirements for 97.5% of healthy population (Ross CA, Taylor CL, Yaktine AL, Del Valle, HB eds. Dietary Reference Intakes for Calcium and Vitamin D. Washington D.C.: The National Academies Press; 2011)
  • Tolerable Upper Limit (UL) - maximum amount of intake unlikely to cause adverse health effects in almost all individuals in the general population (Ross CA, Taylor CL, Yaktine AL, Del Valle, HB eds. Dietary Reference Intakes for Calcium and Vitamin D. Washington D.C.: The National Academies Press; 2011)
  • Endocrine Society guideline definitions of serum vitamin D status4
    • deficiency < 20 ng/mL (50 nmol/L)
    • insufficiency 21-29 ng/mL (525-725 nmol/L)
    • sufficiency ≥ 30 ng/mL (75 nmol/L)

References

General references used

  1. Wilczynski C, Camacho P. Calcium use in the management of osteoporosis: continuing questions and controversies. Curr Osteoporos Rep. 2014 Dec;12(4):396-402
  2. Bolland MJ, Grey A, Reid IR. Should we prescribe calcium or vitamin D supplements to treat or prevent osteoporosis? Climacteric. 2015;18 Suppl 2:22-31
  3. Bauer DC. Clinical practice. Calcium supplements and fracture prevention. N Engl J Med. 2013 Oct 17;369(16):1537-43full-text, commentary can be found in N Engl J Med 2013 Oct 17;369(16):1537
  4. Holick MF, Binkley NC, Bischoff-Ferrari HA, et al.; Endocrine Society. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011 Jul;96(7):1911-30, correction can be found in J Clin Endocrinol Metab 2011 Dec;96(12):3908

Recommendation grading systems used

  • American Association of Clinical Endocrinologists/American College of Endocrinology (AACE/ACE) grading recommendations
    • recommendation grade
      • Grade A - homogeneous evidence from well-designed, randomized controlled trials and cohort-controlled trials with sufficient statistical power; ≥ 1 conclusive level 1 publications demonstrating benefit vs. risk
      • Grade B - evidence from ≥ 1 well-designed clinical trial, cohort- or case-controlled analytic study, or meta-analysis; no conclusive level 1 publications, ≥ 1 conclusive level 2 publications demonstrating benefit vs. risk
      • Grade C - evidence based on clinical experience, descriptive studies, or expert consensus opinion; no conclusive level 1 or 2 publications, ≥ 1 conclusive level 3 publications demonstrating benefit vs. risk
      • Grade D - not rated; no conclusive level 1, 2, 3 publications demonstrating benefit vs. risk or vice versa
    • levels of evidence
      • Level 1 - strong evidence; from meta-analysis of randomized controlled trials (RCT)
      • Level 2 - intermediate evidence; from meta-analysis of nonrandomized prospective or case-controlled trials, nonrandomized controlled trials, prospective cohort studies, or prospective case-control studies
      • Level 3 - weak evidence; from cross-sectional studies, surveillance studies, consecutive case series, single case reports
      • Level 4 - no evidence (theory, opinion, consensus, or review)
    • Reference - AACE/ACE clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis (cxh118329320pmdc27662240pEndocr Pract 2016 Sep 2;22(Suppl 4):1)
  • United States Preventive Services Task Force (USPSTF) grades of recommendation (after July 2012)
    • Grade A - USPSTF recommends the service with high certainty of substantial net benefit
    • Grade B - USPSTF recommends the service with high certainty of moderate net benefit or moderate certainty of moderate-to-substantial net benefit
    • Grade C - USPSTF recommends selectively offering or providing the service (based on professional judgment and patient preference) with at least moderate certainty of small net benefit
    • Grade D - USPSTF recommends against providing the service with moderate-to-high certainty of no net benefit or harms outweighing benefits
    • Grade I - insufficient evidence to assess balance of benefits and harms
    • Reference - USPSTF Grade Definitions
  • Endocrine Society uses Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system
    • strength of recommendation
      • Strong recommendation - guideline panel members have high confidence that desirable effects of recommendation outweigh undesirable effects (or vice versa)
      • Weak recommendation - guideline panel members conclude with less confidence that desirable effects of recommendation probably outweigh undesirable effects, or benefits and harms are finely balanced, or appreciable uncertainty
    • quality of evidence
      • High-quality evidence - consistent evidence from well-performed randomized controlled trials, or exceptionally strong evidence from unbiased observational studies
      • Moderate-quality evidence - randomized controlled trials with important limitations (inconsistent results, methodological flaws, indirect or imprecise evidence), or unusually strong evidence from unbiased observational studies
      • Low-quality evidence - ≥ 1 critical outcome from observational studies, randomized controlled trials with serious flaws, or indirect evidence
      • Very low-quality evidence - ≥ 1 of the critical outcomes from unsystematic clinical observations or very indirect evidence
  • American College of Rheumatology (ACR) levels of recommendations
    • Strong recommendation - confident that desirable effects of following recommendation outweigh the undesirable effects (or vice versa), course of action would apply to all or almost all patients, and only a small proportion would not want to follow the recommendation
    • Conditional recommendation - desirable effects of following the recommendation probably outweigh the undesirable effects, course of action applies to the majority of patients, but some may not want to follow the recommendation, warrants shared decision-making
    • Good practice recommendation - following recommendation may outweigh the undesirable effects (or vice versa), supporting evidence is indirect and inadequate
    • Reference - ACR guideline for the prevention and treatment of glucocorticoid-induced osteoporosis (28585410Arthritis Care Res (Hoboken) 2017 Aug;69(8):1095)

Synthesized Recommendation Grading System for DynaMed Content

  • The DynaMed Team systematically monitors clinical evidence to continuously provide a synthesis of the most valid relevant evidence to support clinical decision-making (see 7-Step Evidence-Based Methodology).
  • Guideline recommendations summarized in the body of a DynaMed topic are provided with the recommendation grading system used in the original guideline(s), and allow users to quickly see where guidelines agree and where guidelines differ from each other and from the current evidence.
  • In DynaMed content, we synthesize the current evidence, current guidelines from leading authorities, and clinical expertise to provide recommendations to support clinical decision-making in the Overview & Recommendations section.
  • We use the Grading of Recommendations Assessment, Development and Evaluation (GRADE) to classify synthesized recommendations as Strong or Weak.
    • Strong recommendations are used when, based on the available evidence, clinicians (without conflicts of interest) consistently have a high degree of confidence that the desirable consequences (health benefits, decreased costs and burdens) outweigh the undesirable consequences (harms, costs, burdens).
    • Weak recommendations are used when, based on the available evidence, clinicians believe that desirable and undesirable consequences are finely balanced, or appreciable uncertainty exists about the magnitude of expected consequences (benefits and harms). Weak recommendations are used when clinicians disagree in judgments of relative benefit and harm, or have limited confidence in their judgments. Weak recommendations are also used when the range of patient values and preferences suggests that informed patients are likely to make different choices.
  • DynaMed synthesized recommendations (in the Overview & Recommendations section) are determined with a systematic methodology:
    • Recommendations are initially drafted by clinical editors (including ≥ 1 with methodological expertise and ≥ 1 with content domain expertise) aware of the best current evidence for benefits and harms, and the recommendations from guidelines.
    • Recommendations are phrased to match the strength of recommendation. Strong recommendations use "should do" phrasing, or phrasing implying an expectation to perform the recommended action for most patients. Weak recommendations use "consider" or "suggested" phrasing.
    • Recommendations are explicitly labeled as Strong recommendations or Weak recommendations when a qualified group has explicitly deliberated on making such a recommendation. Group deliberation may occur during guideline development. When group deliberation occurs through DynaMed Team-initiated groups:
      • Clinical questions will be formulated using the PICO (Population, Intervention, Comparison, Outcome) framework for all outcomes of interest specific to the recommendation to be developed.
      • Systematic searches will be conducted for any clinical questions where systematic searches were not already completed through DynaMed content development.
      • Evidence will be summarized for recommendation panel review including for each outcome, the relative importance of the outcome, the estimated effects comparing intervention and comparison, the sample size, and the overall quality rating for the body of evidence.
      • Recommendation panel members will be selected to include at least 3 members that together have sufficient clinical expertise for the subject(s) pertinent to the recommendation, methodological expertise for the evidence being considered, and experience with guideline development.
      • All recommendation panel members must disclose any potential conflicts of interest (professional, intellectual, and financial), and will not be included for the specific panel if a significant conflict exists for the recommendation in question.
      • Panel members will make Strong recommendations if and only if there is consistent agreement in a high confidence in the likelihood that desirable consequences outweigh undesirable consequences across the majority of expected patient values and preferences. Panel members will make Weak recommendations if there is limited confidence (or inconsistent assessment or dissenting opinions) that desirable consequences outweigh undesirable consequences across the majority of expected patient values and preferences. No recommendation will be made if there is insufficient confidence to make a recommendation.
      • All steps in this process (including evidence summaries which were shared with the panel, and identification of panel members) will be transparent and accessible in support of the recommendation.
    • Recommendations are verified by ≥ 1 editor with methodological expertise, not involved in recommendation drafting or development, with explicit confirmation that Strong recommendations are adequately supported.
    • Recommendations are published only after consensus is established with agreement in phrasing and strength of recommendation by all editors.
    • If consensus cannot be reached then the recommendation can be published with a notation of "dissenting commentary" and the dissenting commentary is included in the topic details.
    • If recommendations are questioned during peer review or post publication by a qualified individual, or reevaluation is warranted based on new information detected through systematic literature surveillance, the recommendation is subject to additional internal review.

DynaMed Editorial Process

  • DynaMed topics are created and maintained by the DynaMed Editorial Team and Process.
  • All editorial team members and reviewers have declared that they have no financial or other competing interests related to this topic, unless otherwise indicated.
  • DynaMed content includes Practice-Changing Updates, with support from our partners, McMaster University and F1000.

Special acknowledgements

On behalf of the American College of Physicians
  • Barbara Turner, MD, MSEd, MACP, ACP Deputy Editor, Clinical Decision Resource, as part of the ACP-EBSCO Health collaboration, managed the ACP peer review of the Overview and Recommendations section and related clinical content in this topic.
  • DynaMed topics are written and edited through the collaborative efforts of the above individuals. Deputy Editors, Section Editors, and Topic Editors are active in clinical or academic medical practice. Recommendations Editors are actively involved in development and/or evaluation of guidelines.
  • Editorial Team role definitions
    Topic Editors define the scope and focus of each topic by formulating a set of clinical questions and suggesting important guidelines, clinical trials, and other data to be addressed within each topic. Topic Editors also serve as consultants for the internal DynaMed Editorial Team during the writing and editing process, and review the final topic drafts prior to publication.
    Section Editors have similar responsibilities to Topic Editors but have a broader role that includes the review of multiple topics, oversight of Topic Editors, and systematic surveillance of the medical literature.
    Recommendations Editors provide explicit review of Overview and Recommendations sections to ensure that all recommendations are sound, supported, and evidence-based. This process is described in "Synthesized Recommendation Grading."
    Deputy Editors oversee DynaMed internal publishing groups. Each is responsible for all content published within that group, including supervising topic development at all stages of the writing and editing process, final review of all topics prior to publication, and direction of an internal team.

How to cite

National Library of Medicine, or "Vancouver style" (International Committee of Medical Journal Editors):

  • DynaMed [Internet]. Ipswich (MA): EBSCO Information Services. 1995 - . Record No. T115372, Calcium and Vitamin D for Treatment and Prevention of Osteoporosis; [updated 2018 Nov 30, cited place cited date here]. Available from https://www.dynamed.com/topics/dmp~AN~T115372. Registration and login required.

Published by EBSCO Information Services. Copyright © 2020, EBSCO Information Services. All rights reserved. No part of this may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, or by any information storage and retrieval system, without permission.

EBSCO Information Services accepts no liability for advice or information given herein or errors/omissions in the text. It is merely intended as a general informational overview of the subject for the healthcare professional.

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