Ngc_10941_1.doc

Complete Summary
GUIDELINE TITLE
BIBLIOGRAPHIC SOURCE(S)
American College of Obstetricians and Gynecologists (ACOG). Osteoporosis. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2004 Jan. 14 p. (ACOG practice bulletin; no. 50). [78 references] GUIDELINE STATUS
This is the current release of the guideline. COMPLETE SUMMARY CONTENT
SCOPE METHODOLOGY - including Rating Scheme and Cost Analysis RECOMMENDATIONS EVIDENCE SUPPORTING THE RECOMMENDATIONS BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS CONTRAINDICATIONS QUALIFYING STATEMENTS IMPLEMENTATION OF THE GUIDELINE INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES IDENTIFYING INFORMATION AND AVAILABILITY DISCLAIMER DISEASE/CONDITION(S)
GUIDELINE CATEGORY
Diagnosis Management Prevention Screening Treatment CLINICAL SPECIALTY
Endocrinology Family Practice Geriatrics Internal Medicine Obstetrics and Gynecology Preventive Medicine Radiology INTENDED USERS
GUIDELINE OBJECTIVE(S)
• To aid practitioners in making decisions about appropriate obstetric and • To discuss appropriate screening strategies and significant pharmacologic interventions available to prevent and treat osteoporosis TARGET POPULATION
• Postmenopausal women with or at risk of developing osteoporosis INTERVENTIONS AND PRACTICES CONSIDERED
Screening
1. Bone mineral density testing using dual-energy x-ray absorptiometry (DXA) 2. Peripheral bone densitometry using quantitative ultrasonography, single- energy X-ray absorptiometry, peripheral DXA, and peripheral quantitative computed tomography Prevention
1. Counseling regarding lifestyle change including weight-bearing and muscle strengthening exercises, adequate calcium consumption, adequate vitamin D consumption, smoking cessation, moderation of alcohol consumption and fall prevention strategies 2. Pharmacotherapy, including estrogen, bisphosphonates (alendronate and Treatment
1. Estrogen 2. Bisphosphonates (alendronate and risendronate) 3. Selective estrogen receptor modulators (currently only raloxifene is available) 4. Salmon calcitonin 5. Human recombinant parathyroid hormone (PTH) 6. Combination therapy 7. Treatment initiation and monitoring MAJOR OUTCOMES CONSIDERED
METHODOLOGY
METHODS USED TO COLLECT/SELECT EVIDENCE
Hand-searches of Published Literature (Primary Sources) Hand-searches of Published Literature (Secondary Sources) Searches of Electronic Databases DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE
The MEDLINE database, the Cochrane Library, and American College of Obstetricians and Gynecologists' own internal resources and documents were used to conduct a literature search to locate relevant articles published between January 1985 and October 2003. The search was restricted to articles published in the English language. Priority was given to articles reporting results of original research, although review articles and commentaries also were consulted. Abstracts of research presented at symposia and scientific conferences were not considered adequate for inclusion in this document. Guidelines published by organizations or institutions such as the National Institutes of Health and the American College of Obstetricians and Gynecologists were reviewed, and additional studies were located by reviewing bibliographies of identified articles. When reliable research was not available, expert opinions from obstetrician–gynecologists were used. NUMBER OF SOURCE DOCUMENTS
METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE
EVIDENCE
Weighting According to a Rating Scheme (Scheme Given) RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE
Studies were reviewed and evaluated for quality according to the method outlined by the U.S. Preventive Services Task Force: I: Evidence obtained from at least 1 properly designed randomized controlled
trial.
II-1: Evidence obtained from well-designed controlled trials without
randomization.
II-2: Evidence obtained from well-designed cohort or case–control analytic
studies, preferably from more than 1 center or research group.
II-3: Evidence obtained from multiple time series with or without the
intervention. Dramatic results in uncontrolled experiments also could be regarded
as this type of evidence.
III: Opinions of respected authorities, based on clinical experience, descriptive
studies, or reports of expert committees.
METHODS USED TO ANALYZE THE EVIDENCE
Review of Published Meta-Analyses Systematic Review DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE
METHODS USED TO FORMULATE THE RECOMMENDATIONS
DESCRIPTION OF METHODS USED TO FORMULATE THE
RECOMMENDATIONS
Analysis of available evidence was given priority in formulating recommendations. When reliable research was not available, expert opinions from obstetrician-gynecologists were used. See also the "Rating Scheme for the Strength of Recommendations" field regarding Grade C recommendations. RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS
Based on the highest level of evidence found in the data, recommendations are provided and graded according to the following categories: Level A — Recommendations are based on good and consistent scientific
evidence.
Level B — Recommendations are based on limited or inconsistent scientific
evidence.
Level C — Recommendations are based primarily on consensus and expert
opinion.
COST ANALYSIS
Guideline developers reviewed published cost analyses. METHOD OF GUIDELINE VALIDATION
DESCRIPTION OF METHOD OF GUIDELINE VALIDATION
Practice Bulletins are validated by two internal clinical review panels composed of practicing obstetrician-gynecologists generalists and sub-specialists. The final guidelines are also reviewed and approved by the American College of Obstetricians and Gynecologists (ACOG) Executive Board. RECOMMENDATIONS
MAJOR RECOMMENDATIONS
The grades of evidence (I-III) and levels of recommendations (A-C) are defined at the end of "Major Recommendations" field. The following recommendations are based on good and consistent
scientific evidence (Level A):
• Treatment should be initiated to reduce fracture risk in postmenopausal women who have experienced a fragility or low-impact fracture. • Treatment should be instituted in those postmenopausal women with bone mineral density T scores less than -2 by central dual-energy x-ray absorptiometry (DXA) in the absence of risk factors and in women with T scores less than -1.5 in the presence of 1 or more risk factors. • First-line pharmacologic options determined by the U.S. Food and Drug Administration (FDA) to be safe and effective for osteoporosis prevention (bisphosphonates [alendronate and risedronate], raloxifene, and estrogen) should be used. • First-line pharmacologic options determined by the FDA to be safe and effective for osteoporosis treatment (bisphosphonates [alendronate and risedronate], raloxifene, calcitonin, and parathyroid hormone [PTH]) should be used. The following recommendations are based on limited or inconsistent
scientific evidence (Level B):
• Women should be counseled about the following preventive measures: • Adequate calcium consumption, using dietary supplements if dietary • Adequate vitamin D consumption (400 to 800 IU daily) and the natural • Regular weight-bearing and muscle-strengthening exercises to reduce • Bone mineral density testing should be recommended to all postmenopausal • Bone mineral density testing may be recommended for postmenopausal women younger than 65 years who have 1 or more risk factors for osteoporosis (see box "Risk Factors for Osteoporotic Fracture in Postmenopausal Women," below). • Bone mineral density testing should be performed on all postmenopausal women with fractures to confirm the diagnosis of osteoporosis and determine disease severity. • In the absence of new risk factors, screening should not be performed more The following recommendations are based primarily on consensus and
expert opinion (Level C):
• Women should be counseled on the risks of osteoporosis and related fragility fractures. Such counseling should be part of the annual gynecologic examination. Table. Risk Factors for Osteoporotic Fracture in Postmenopausal Women
• Early menopause (age younger than 45 years) or bilateral • Prolonged premenopausal amenorrhea (>1 year) • Impaired eyesight despite adequate correction *A patient's current use of hormone therapy does not preclude estrogen deficiency. Data from Osteoporosis prevention, diagnosis, and therapy. NIH Consens Statement 2000;17(1):1-45. Definitions:
Grades of Evidence
I: Evidence obtained from at least one properly designed randomized controlled
trial
II-1: Evidence obtained from well-designed controlled trials without
randomization
II-2: Evidence obtained from well-designed cohort or case-control analytic
studies, preferably from more than one center or research group
II-3: Evidence obtained from multiple time series with or without the
intervention. Dramatic results in uncontrolled experiments also could be regarded
as this type of evidence.
III: Opinions of respected authorities, based on clinical experience, descriptive
studies, or reports of expert committees
Levels of Recommendation
Level A — Recommendations are based on good and consistent scientific
evidence.
Level B — Recommendations are based on limited or inconsistent scientific
evidence.
Level C — Recommendations are based primarily on consensus and expert
opinion.
CLINICAL ALGORITHM(S)
EVIDENCE SUPPORTING THE RECOMMENDATIONS
TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS
The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations"). BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS
POTENTIAL BENEFITS
Appropriate screening, prevention, and treatment of osteoporosis POTENTIAL HARMS
• When estrogen or hormone therapy is discontinued, bone turnover increases • Although the risks of long-term use of estrogen or hormone therapy are small, many recommend such therapy be used for the shortest period at the lowest possible dose. The Women's Health Initiative study indicated a significantly increased risk of cardiovascular events and breast cancer for women taking combined estrogen and progestin therapy. • Bisphosphonates may cause upper gastrointestinal side effects • Although generally well tolerated, side effects of raloxifene include vasomotor symptoms (hot flashes and night sweats). It also has risks (deep vein thrombosis and pulmonary embolism) similar to those of estrogens. • Calcitonin is generally well tolerated. Its side effects are nausea, local inflammation (injection), flushing of the face or hands (injection), and nasal irritation (nasal spray). • Parathyroid hormone treatment is expensive and requires daily injections. CONTRAINDICATIONS
CONTRAINDICATIONS
Bisphosphonates are contraindicated in individuals with reflux, gastroesophageal reflux disease, and other esophageal abnormalities. QUALIFYING STATEMENTS
QUALIFYING STATEMENTS
These guidelines should not be construed as dictating an exclusive course of treatment or procedure. Variations in practice may be warranted based on the needs of the individual patient, resources, and limitations unique to the institution or type of practice. IMPLEMENTATION OF THE GUIDELINE
DESCRIPTION OF IMPLEMENTATION STRATEGY
An implementation strategy was not provided. IMPLEMENTATION TOOLS
Foreign Language Translations Patient Resources For information about availability, see the "Availability of Companion Documents" and "Patient Resources" fields below. INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES
IOM CARE NEED
IOM DOMAIN
IDENTIFYING INFORMATION AND AVAILABILITY
BIBLIOGRAPHIC SOURCE(S)
American College of Obstetricians and Gynecologists (ACOG). Osteoporosis. Washington (DC): American College of Obstetricians and Gynecologists (ACOG); 2004 Jan. 14 p. (ACOG practice bulletin; no. 50). [78 references] ADAPTATION
Not applicable: The guideline was not adapted from another source. DATE RELEASED
GUIDELINE DEVELOPER(S)
American College of Obstetricians and Gynecologists - Medical Specialty Society SOURCE(S) OF FUNDING
American College of Obstetricians and Gynecologists (ACOG) GUIDELINE COMMITTEE
American College of Obstetricians and Gynecologists (ACOG) Committee on Practice Bulletins-Gynecology COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE
FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST
GUIDELINE STATUS
This is the current release of the guideline. GUIDELINE AVAILABILITY
Print copies: Available for purchase from the American College of Obstetricians and Gynecologists (ACOG) Distribution Center, PO Box 4500, Kearneysville, WV 25430-4500; telephone, 800-762-2264, ext. 192; e-. The ACOG Bookstore is available online at the ACOG Web site. AVAILABILITY OF COMPANION DOCUMENTS
PATIENT RESOURCES
• Osteoporosis. Atlanta (GA): American College of Obstetricians and Electronic copies: Available from the Gynecologists (ACOG) Web site. Copies are also available in Spanish. Print copies: Available for purchase from the American College of Obstetricians and Gynecologists (ACOG) Distribution Center, PO Box 4500, Kearneysville, WV 25430-4500; telephone, 800-762-2264, ext. 192; e-mail: sales@acog.org. The . Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content. NGC STATUS
This NGC summary was completed by ECRI Institute on August 6, 2007. The information was verified by the guideline developer on September 10, 2007. COPYRIGHT STATEMENT
This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions. DISCLAIMER
NGC DISCLAIMER
The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site. All guidelines summarized by NGC and hosted on our site are produced under the auspices of medical specialty societies, relevant professional associations, public or private organizations, other government agencies, health care organizations or plans, and similar entities. Guidelines represented on the NGC Web site are submitted by guideline developers, and are screened solely to determine that they meet the NGC Inclusion Criteria which may be found at . NGC, AHRQ, and its contractor ECRI make no warranties concerning the content or clinical efficacy or effectiveness of the clinical practice guidelines and related materials represented on this site. Moreover, the views and opinions of developers or authors of guidelines represented on this site do not necessarily state or reflect those of NGC, AHRQ, or its contractor ECRI, and inclusion or hosting of guidelines in NGC may not be used for advertising or commercial endorsement purposes. Readers with questions regarding guideline content are directed to contact the guideline developer. 1998-2007 National Guideline Clearinghouse

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