The levels of evidence (1to 4) and the recommendation grades (A to D) are defined at the end of the "Major Recommendations" field.
Executive Summary of Recommendations
The following recommendations (labeled "R") are evidence based (Grades A, B, and C) or are based on expert opinion because of a lack of conclusive clinical evidence (Grade D). The best evidence level (BEL), which corresponds to the best conclusive evidence found, accompanies the recommendation grade in this Executive Summary.
What Measures Can Be Taken to Prevent Bone Loss?
R1. Maintain adequate calcium intake; use calcium supplements, if needed, to meet minimal required intake (Grade A; BEL 1).
R2. Maintain adequate vitamin D intake; supplement vitamin D, if needed, to maintain serum levels of 25-hydroxyvitamin D [25(OH)D] between 30 and 60 ng/mL (Grade A; BEL 1).
R3. Limit alcohol intake to no more than 2 servings per day (Grade B; BEL 2).
R4. Limit caffeine intake (Grade C; BEL 3).
R5. Avoid or stop smoking (Grade B; BEL 2).
R6. Maintain an active lifestyle, including weight-bearing exercises for at least 30 minutes daily (Grade B; BEL 2).
What Nonpharmacologic Measures Can Be Recommended for Treatment of Osteoporosis?
All the foregoing measures plus the following:
R7. Maintain adequate protein intake (Grade B; BEL 3).
R8. Use proper body mechanics (Grade B; BEL 1).
R9. Consider the use of hip protectors in individuals with a high risk of falling (Grade B; BEL 1).
R10. Take measures to reduce the risk of falling (Grade B; BEL 2).
R11. Consider referral for physical therapy and occupational therapy (Grade B; BEL 1).
Who Needs to Be Screened for Osteoporosis?
R12. Women 65 years old or older (Grade B; BEL 2)
R13. Younger postmenopausal women at increased risk of fracture, based on a list of risk factors (see section 4.5 in the original guideline document) (Grade C; BEL 2)
How Is Osteoporosis Diagnosed?
R14. Use a central dual-energy x-ray absorptiometry (DXA) measurement (Grade B; BEL 3).
R15. In the absence of fracture, osteoporosis is defined as a T-score of -2.5 or below in the spine (anteroposterior), femoral neck, or total hip (Grade B; BEL 2).
R16. Osteoporosis is defined as the presence of a fracture of the hip or spine (see section 4.4.2 in the original guideline document) (in the absence of other bone conditions) (Grade B; BEL 3).
How Is Osteoporosis Evaluated?
R17. Evaluate for secondary osteoporosis (Grade B; BEL 2).
R18. Evaluate for prevalent vertebral fractures (see section 4.7.1 in the original guideline document) (Grade B; BEL 2).
Who Needs Pharmacologic Therapy?
R19. Those patients with a history of a fracture of the hip or spine (Grade A; BEL 1)
R20. Patients without a history of fractures but with a T-score of -2.5 or lower (Grade A; BEL 1)
R21. Patients with a T-score between -1.0 and -2.5 if Fracture Risk Assessment Tool (FRAX) (see section 4.5 in the original guideline document) major osteoporotic fracture probability is ≥20% or hip fracture probability is ≥3% (Grade A; BEL 2)
What Drugs Can Be Used to Treat Osteoporosis?
Use drugs with proven antifracture efficacy:
R22. Use alendronate, risedronate, zoledronic acid, and denosumab as the first line of therapy (Grade A; BEL 1).
R23. Use ibandronate as a second-line agent (Grade A; BEL 1).
R24. Use raloxifene as a second- or third-line agent (Grade A; BEL 1).
R25. Use calcitonin as the last line of therapy (Grade C; BEL 2).
R26. Use teriparatide for patients with very high fracture risk or patients in whom bisphosphonate therapy has failed (Grade A; BEL 1).
R27. Advise against the use of combination therapy (Grade B; BEL 2).
How Is Treatment Monitored?
R28. Obtain a baseline DXA, and repeat DXA every 1 to 2 years until findings are stable. Continue with follow-up DXA every 2 years or at a less frequent interval (Grade B; BEL 2).
R29. Monitor changes in spine or total hip bone mineral density (BMD) (Grade C; BEL 2).
R30. Follow-up of patients should be in the same facility, with the same machine, and, if possible, with the same technologist (Grade B; BEL 2).
R31. Bone turnover markers may be used at baseline to identify patients with high bone turnover and can be used to follow the response to therapy (Grade C; BEL 2).
What Is Successful Treatment of Osteoporosis?
R32. BMD is stable or increasing, and no fractures are present (Grade B; BEL 2).
R33. For patients taking antiresorptive agents, bone turnover markers at or below the median value for premenopausal women are achieved (see section 4.9 in the original guideline document) (Grade B; BEL 2).
R34. One fracture is not necessarily evidence of failure. Consider alternative therapy or reassessment for secondary causes of bone loss for patients who have recurrent fractures while receiving therapy (Grade B; BEL 2).
How Long Should Patients Be Treated?
R35. For treatment with bisphosphonates, if osteoporosis is mild, consider a "drug holiday" after 4 to 5 years of stability. If fracture risk is high, consider a drug holiday of 1 to 2 years after 10 years of treatment (Grade B; BEL 1).
R36. Follow BMD and bone turnover markers during a drug holiday period, and reinitiate therapy if bone density declines substantially, bone turnover markers increase, or a fracture occurs (Grade C; BEL 3).
When Should Patients Be Referred to Clinical Endocrinologists?
R37. When a patient with normal BMD sustains a fracture without major trauma (Grade C; BEL 4).
R38. When recurrent fractures or continued bone loss occurs in a patient receiving therapy without obvious treatable causes of bone loss (Grade C; BEL 4).
R39. When osteoporosis is unexpectedly severe or has unusual features (Grade C; BEL 4).
R40. When a patient has a condition that complicates management (for example, renal failure, hyperparathyroidism, or malabsorption) (Grade C; BEL 4).
2010 American Association of Clinical Endocrinologists Criteria for Rating of Published Evidence*
||Meta-analysis of randomized controlled trials
||Randomized controlled trial
||Meta-analysis of nonrandomized prospective or case-controlled trials
||Nonrandomized controlled trial
||Prospective cohort study
||Retrospective case-control study
||Surveillance study (registries, surveys, epidemiologic study)
||Consecutive case series
||Single case reports
||No evidence (theory, opinion, consensus, or review)
*1 = strong evidence; 2 = intermediate evidence; 3 = weak evidence; 4 = no evidence.
From Mechanick JI, Camacho PM, Cobin RH, et al (American Association of Clinical Endocrinologists Clinical Practice Guidelines Subcommittee). American Association of Clinical Endocrinologists protocol for standardized production of clinical practice guidelines—2010 update. Endocr Pract. 2010;16:270-283.
American Association of Clinical Endocrinologists Criteria for Grading of Recommendations
Homogeneous evidence from multiple well-designed randomized controlled trials with sufficient statistical power
Homogeneous evidence from multiple well-designed cohort controlled trials with sufficient statistical power
≥1 conclusive level 1 publications demonstrating benefit >> risk
Evidence from at least 1 large well-designed clinical trial, cohort or case-controlled analytic study, or meta-analysis
No conclusive level 1 publication; ≥1 conclusive level 2 publications demonstrating benefit >> risk
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 >> risk
No conclusive risk at all and no conclusive benefit demonstrated by evidence
No conclusive level 1, 2, or 3 publication demonstrating benefit >> risk
Conclusive level 1, 2, or 3 publication demonstrating risk >> benefit
From Mechanick JI, Bergman DA, Braithwaite SS, Palumbo PJ (American Association of Clinical Endocrinologists Ad Hoc Task Force for Standardized Production of Clinical Practice Guidelines). American Association of Clinical Endocrinologists protocol for standardized production of clinical practice guidelines [published correction appears in Endocr Pract. 2008;14:802-803]. Endocr Pract. 2004;10:353-361.