Screening and Monitoring Tests for Osteopenia/Osteoporosis

20, 2012

Health Technology Assessment

Screening and Monitoring Tests for Osteopenia/Osteoporosis

Final Report

October 20, 2014

Health Technology Assessment Program (HTA) Washington State Health Care Authority P.O. Box 42712 Olympia, WA 98504-2712 (360) 725-5126 hca.hta shtap@hca.

Screening and Monitoring Tests for Osteopenia/Osteoporosis A Health Technology Assessment

Prepared for Washington State Healthcare Authority

FINAL REPORT October 20, 2014

Acknowledgement This report was prepared by: Hayes, Inc. 157 S. Broad Street Suite 200 Lansdale, PA 19446 P: 215.855.0615 F: 215.855.5218 This report is intended to provide research assistance and general information only. It is not intended to be used as the sole basis for determining coverage policy or defining treatment protocols or medical modalities, nor should it be construed as providing medical advice regarding treatment of an individual's specific case. Any decision regarding claims eligibility or benefits, or acquisition or use of a health technology is solely within the discretion of your organization. Hayes, Inc. assumes no responsibility or liability for such decisions. Hayes employees and contractors do not have material, professional, familial, or financial affiliations that create actual or potential conflicts of interest related to the preparation of this report

WA ? Health Technology Assessment

October 20, 2014

Table of Contents

EVIDENCE SUMMARY.................................................................................................................................... 1

Summary of Background........................................................................................................................... 1

Summary of Technical Aspects of DXA ..................................................................................................... 7

Policy Context ........................................................................................................................................... 8

Summary of Review Objectives and Methods .......................................................................................... 9

Summary of Search Results..................................................................................................................... 13

Findings ................................................................................................................................................... 16

Key Question #1: Is there direct evidence that screening for osteoporosis and low bone density improves health outcomes, clinical management decisions, or patient choices? 1a: For individual patients, and do these outcomes vary according to age, sex, or other risk factors for BMD or fracture? 1b: In populations, and do these outcomes vary by population characteristics?................ 16 Key Question #2: Is there direct evidence that monitoring (serial testing) for osteoporosis and low bone density improves health outcomes, clinical management decisions, or patient choices? 2a: For individual patients, and do these outcomes vary according to age, sex, other risk factors (including previous BMD measurements), treatment status, or testing interval? 2b: In populations, and do these outcomes vary by population characteristics or testing interval? ............................................. 22 Key Question #2c: What is the minimum interval required to detect transition from normal or low BMD to osteoporosis or to assess treatment effect? .......................................................................... 22 Key Question #3: What is the number needed to screen (NNS) to prevent 1 fracture in subgroups defined by age, sex, and other risk factors?......................................................................................... 27 Key Question #4: Are bone density tests safe and what are the potential downstream adverse effects? ................................................................................................................................................. 30 Key Question #5: What are the costs and cost-effectiveness of osteoporosis screening and monitoring? .......................................................................................................................................... 32 Practice Guidelines.................................................................................................................................. 34

Selected Payer Policies............................................................................................................................ 38

Overall Summary and Discussion............................................................................................................ 39

TECHNICAL REPORT .................................................................................................................................... 42

Clinical Background................................................................................................................................. 42

Technical Aspects of DXA........................................................................................................................ 58

Review Objectives and Analytic Framework........................................................................................... 60

Methods .................................................................................................................................................. 63

Search Results ......................................................................................................................................... 66

Literature Review.................................................................................................................................... 67

Screening for Osteopenia/Osteoporosis: Final Evidence Report

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October 20, 2014

KQ#1: Is there direct evidence that screening for osteoporosis and low bone density improves health outcomes, clinical management decisions, or patient choices? 1a: For individual patients, and do these outcomes vary according to age, sex, or other risk factors for BMD or fracture? 1b: In populations, and do these outcomes vary by population characteristics?.......................................... 67

KQ#2: Is there direct evidence that monitoring (serial testing) for osteoporosis and low bone density improves health outcomes, clinical management decisions, or patient choices? 2a: For individual patients, and do these outcomes vary according to age, sex, other risk factors (including previous BMD measurements), treatment status, or testing interval? 2b: In populations, and do these outcomes vary by population characteristics or testing interval? ............................................. 71

KQ #2c: What is the minimum interval required to detect transition from normal or low BMD to osteoporosis or to assess treatment effect?........................................................................................ 71

KQ #3: What is the number needed to screen (NNS) to prevent 1 fracture in subgroups defined by age, sex, and other risk factors?........................................................................................................... 77

KQ #4: Are bone density tests safe and what are the potential downstream adverse effects?.......... 81

KQ #5: What are the costs and cost-effectiveness of osteoporosis screening and monitoring? ........ 82

Practice Guidelines.................................................................................................................................. 86

Selected Payer Policies............................................................................................................................ 88

References .............................................................................................................................................. 92

Washington State Agency Utilization Data ............................................................................................. 99

APPENDICES .............................................................................................................................................. 114

APPENDIX I. Search Strategy ................................................................................................................. 114

APPENDIX II. Overview of Evidence Quality Assessment Methods ...................................................... 117

APPENDIX III. Evidence Tables .............................................................................................................. 121

Evidence Table IIIa. Controlled Studies Evaluating the Effectiveness of Osteoporosis Screening by Dual X-Ray Absorptiometry (DXA) in Individuals (Key Question #1a) ................................................ 121

Evidence Table IIIb. Longitudinal Studies Designed to Estimate Optimal Screening Intervals (Key Question #2c) ..................................................................................................................................... 124

Evidence Table IIIc. Studies Reporting Calculations of Numbers Needed to Screen (NNS) (Key Question #3) ....................................................................................................................................... 127

Evidence Table IIId. Economic Evaluations (Key Question #5)........................................................... 129

Appendix IV. Summary of Practice Guidelines...................................................................................... 133

Screening for Osteopenia/Osteoporosis: Final Evidence Report

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List of Tables

Table 1. Interpretation of DXA Results Table 2. Summary of Search Results Table 3. Summary of Findings, Key Questions #1a and #1b Table 4. Summary of Findings, Key Question #2c. Table 5. Summary of Findings, Key Question #3 Table 6: Summary of Findings, Key Question #4 Table 7. Summary of Findings, Key Question #5 Table 8. Summary of Practice Guideline Recommendations Table 9. Components of the WHO FRAX Tool Table 10. Prescription Medications for Osteoporosis

October 20, 2014

Screening for Osteopenia/Osteoporosis: Final Evidence Report

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