Definitions of the levels of evidence (evidence-based A-D, I and consensus-based) are provided at the end of the "Major Recommendations" field.
Screening with Dual Energy X-Ray Absorptiometry (DXA)
Postmenopausal Women
1A. A bone mineral density (BMD) test by DXA is recommended for postmenopausal women aged 65 or older who are not on drug treatment for osteoporosis. Evidence-based: B
1B. For postmenopausal women under age 65, a BMD test by DXA is an option when selected risk factors are present. Consensus-based
NOTE: In addition to advancing age and female sex, risk factors in the Fracture Risk Assessment Tool (FRAX)* model include low body mass index (BMI), personal history of fragility fracture after age 50, parental history of hip fracture, rheumatoid arthritis, long-term exposure to systemic corticosteroids (3 months or more at doses ≥ 5 mg), high alcohol intake (about 3 ounces per day), cigarette smoking, and other causes of secondary osteoporosis (e.g., type 1 diabetes, osteogenesis imperfecta in adults, untreated long-standing hyperthyroidism, hypogonadism or premature menopause (< 45 years), chronic malnutrition, or malabsorption and chronic liver disease). It is useful to review the FRAX model and risk factors with patients.
*FRAX risk charts can be accessed on the FRAX web site: (http://www.shef.ac.uk/FRAX/).
1C. For individuals under age 65 who are at high risk, such as those with a prior fragility fracture after age 50 or glucocorticoid use for 3 months or more at doses ≥ 5 mg, refer to the Fracture Risk Assessment Tool (FRAX) to estimate individual fracture risk. Consensus-based
Premenopausal Women
1D. Routine screening for osteoporosis with a BMD test by DXA is not recommended for premenopausal women. Consensus-based
Men
1E. Screening with DXA is an option for men aged 70 or older with risk factors. Consensus-based
Optimal Screening Frequency
1F. The recommended retesting interval for women not currently on treatment is 5 years. Varying the interval is an option in the presence or absence of risk factors. Consensus-based
NOTE: For a healthy 50-year-old woman with a T-score of -1.1, it may take 10 to 20 years to drop to a T-score of -2.5.
Bone Mineral Density (BMD) Measurement Sites
2A. When BMD testing is indicated, the total proximal femur (total hip), femoral neck, and lumbar spine are recommended measurement sites for DXA to predict risk of osteoporotic fracture in women and men. Evidence-based: B
2B. The lowest T-score from the measurements of the total hip, femoral neck, and lumbar spine (L1 to L4, composite score) is recommended to establish a diagnosis of osteoporosis (T-score ≤ -2.5) or low BMD (T-score between -2.0 and -2.5). Consensus-based
2C. DXA of the forearm (distal one-third of the radius) is an option for patients in whom hip and spine BMD cannot be measured or interpreted. Evidence-based: B
Absolute Fracture Risk
3A. The Fracture Risk Assessment Tool (FRAX*) is strongly recommended for assessing absolute fracture risk in women or men before initiation of treatment. Evidence-based: A
NOTE: FRAX is not designed to assess fracture risk in patients on bisphosphonate treatment.
3B. Pharmacologic treatment for osteoporosis in women or men is recommended when the 10-year probability of hip fracture reaches 3%. Consensus-based
3C. Pharmacologic treatment for osteoporosis in women or men is optional when the 10-year probability of hip fracture is < 3%. Consensus-based
NOTE: The safety and efficacy of long-term use of bisphosphonates for more than 5 to 10 years are uncertain; therefore, the decision to start open-ended treatment in younger patients should be considered carefully.
Nonpharmacologic Interventions
4A. The following lifestyle changes are recommended for all adults:
- Exercise – regular weight-bearing and muscle-building exercise
- Smoking cessation
Consensus-based
4B. Home safety proofing is recommended for postmenopausal women and men at risk of falling. Consensus-based
NOTE: Home safety proofing includes removing rugs, adding grab bars, establishing adequate lighting (e.g., nightlights), and securing electrical cord placement.
4C. The routine use of hip protectors is not recommended as an intervention for reducing the risk of hip fractures in postmenopausal women and men aged 50 or older. Evidence-based: D
Screening for Vitamin D Deficiency
5A. Screening for vitamin D deficiency is not recommended for identifying vitamin D deficiency in adults aged 50 years or older without osteoporosis. Consensus-based
5B. Testing for vitamin D deficiency and supplementation with vitamin D to an acceptable level of ≥ 30 ng/ml before initiating bisphosphonate therapy is recommended. Consensus-based
Dietary and Pharmacologic Interventions
Preventive Measures for All Women and Men
6A. Total daily intake of calcium is recommended for all pre- or postmenopausal women and older men (1,000 mg/day for premenopausal women; 1,200 mg/day for postmenopausal women and men aged 50 or older). Many individuals require supplemental calcium therapy. Evidence-based: B
6B. Total daily intake of vitamin D (at least 1,000 IU/day), preferably vitamin D3, is recommended for all pre- or postmenopausal women and men aged 50 or older. Consensus-based
NOTE:
- Calcium carbonate contains the most elemental calcium per dose. It should be taken with food to enhance absorption.
- Calcium citrate contains less elemental calcium than the carbonate salt, but it is better absorbed and may be preferred in patients with reduced gastric acid production or high gastric pH (e.g., those on long-term H2 antagonist or proton pump inhibitor therapy). It is more expensive and usually requires more tablets to be taken per day than calcium carbonate.
Preventive Measures for Women and Men Without Osteoporosis
6C. Hormone therapy solely for the prevention of osteoporosis is not recommended. Consensus-based
Treatment for Postmenopausal Women Diagnosed with Osteoporosis
First-Line Drug Therapy
6D. Alendronate (10 mg/day or 70 mg/week) is recommended as a first-line therapy for:
- Postmenopausal women with a prior fragility fracture. Evidence-based: A
- Women aged 65 or older with a diagnosis of osteoporosis (T-score ≤ -2.5). Evidence-based: A
- Postmenopausal women with a FRAX* 10-year risk of hip fracture ≥ 3%. Consensus-based
Alendronate is an option for postmenopausal women under the age of 65 diagnosed with osteoporosis (T-score ≤ -2.5), but without a FRAX 10-year risk of hip fracture ≥ 3%. Consensus-based
6E. Risedronate (5 mg/day or 35 mg/week) is a recommended alternative to alendronate for the categories of patients described in 6D above. Evidence-based: A
NOTE:
- Bisphosphonates are not recommended in women of childbearing age without adequate contraception.
- Bisphosphonates should be used with caution in patients with chronic kidney disease and reduced glomerular filtration rate.
- Screening for vitamin D deficiency and supplementation with vitamin D to an acceptable level of > 30 ng/ml before initiating bisphosphonate therapy is recommended. (See Recommendation 5B above: Consensus-based)
- The major determinant of fracture risk reduction with bisphosphonate therapy is continuing to take the therapy.
- Short-term interruption of bisphosphonates is not associated with rapidly rising risk of fracture. Some patients not at high risk for fracture may not need to continue long-term bisphosphonate therapy.
Second-Line Drug Therapy
(The following medications are for use only when alendronate and risedronate are contraindicated or not tolerated in postmenopausal women.)
6F. Raloxifene is an option for postmenopausal women with low risk for thrombotic complications. Evidence-based: B
NOTE: Raloxifene treatment may be particularly applicable to women at high risk for breast cancer.
6G. Ibandronate is an option for postmenopausal women over the age of 65 with a prior vertebral fracture. (See notes for bisphosphonate therapy above.) Evidence-based: B
6H. Nasal calcitonin is an option for postmenopausal women over the age of 65 with a prior vertebral fracture. Evidence-based: B
NOTE: For all second-line therapies listed above, evidence has not demonstrated a statistically significant decrease in the incidence of hip fractures.
Third-Line Drug Therapy
(The following medications are for use only when other treatment modalities are contraindicated or not tolerated in postmenopausal women at high risk of fractures.)
6I. Zoledronic acid (intravenous 5 mg annually) is an option for postmenopausal women over the age of 65 with high risk and a prior vertebral fracture. (See notes for bisphosphonate therapy above.) Evidence-based: B
6J. Teriparatide (recombinant parathyroid hormone [PTH]) by daily injection is an anabolic agent that may be an option for high-risk women not tolerant of or responsive to other agents. It should be used only after specialist evaluation. Evidence-based: B
Preventive Measures for Premenopausal Women
6K. There is no recommendation for or against treatment with any prescribed pharmacologic therapy for premenopausal women. Evidence-based: I
Treatment for Men
6L. Alendronate (10 mg/day or 70 mg/week) is recommended as a first-line therapy for men aged 70 or older diagnosed with osteoporosis or with a FRAX 10-year risk of hip fracture ≥ 3%. Consensus-based
6M. Pharmacologic treatment for osteoporosis is optional in men under the age of 70 who are diagnosed with osteoporosis (T-score ≤ -2.5) but without a FRAX 10-year risk of hip fracture ≥ 3%. Consensus-based
Treatment for Men and Women Taking Corticosteroid Therapy
6N. Alendronate (10 mg/day or 70 mg/week) or risedronate (5 mg/day or 35 mg/week) is recommended as first-line therapy for men and women who are taking oral corticosteroid medication at a dose of ≥ 5 mg/day prednisone or equivalent for a duration of 3 months or more and have a FRAX 10-year risk of hip fracture ≥ 3%. (See notes for bisphosphonate therapy above.) Consensus-based
6O. Teriparatide (recombinant PTH) by daily injection is an anabolic agent that is an option for treating osteoporosis in glucocorticoid-treated patients not tolerant of or responsive to other agents. It should be used only after specialist evaluation. Evidence-based: B
Treatment Duration
6P. There is no recommendation on the optimal treatment durations for the pharmacologic management of osteoporosis. Evidence-based: I
Note: Based on consensus, the guideline development team concluded that short-term interruption of bisphosphonates is not associated with rapidly rising risk of fracture, and some patients not at high risk for fracture may not need to continue long-term bisphosphonate treatment beyond 5 years. Results from trials extending beyond 5 years have shown persistence of benefits.
Monitoring Treatment
7A. Routine BMD testing by DXA is not recommended for monitoring the rate of bone loss after initiation of treatment in women or men. Consensus-based
NOTE: A major determinant of fracture risk reduction with bisphosphonate therapy is continuing to take the therapy.
7B. There is no recommendation for or against routine bone turnover testing with biochemical markers for monitoring women and men taking antiresorptive therapy for osteoporosis. Evidence-based: I
Definitions:
Grades of Recommendations
| Recommendation |
Label Recommendation Statement* |
Evidence Base |
| Evidence-Based Recommendations |
| Evidence-Based, A |
The Guideline Development Team (GDT) strongly recommends the intervention. |
The intervention improves important health outcomes, based on good evidence, and the GDT concludes that benefits substantially outweigh harms and costs. |
| Evidence-Based, B |
The GDT recommends the intervention. |
The intervention improves important health outcomes, based on 1) good evidence that benefits outweigh harms and costs; or 2) fair evidence that benefits substantially outweigh harms and costs. |
| Evidence-Based, C |
The GDT makes no recommendation for or against the intervention.† |
Evidence is sufficient to determine the benefits, harms, and costs of an intervention, and there is at least fair evidence that the intervention improves important health outcomes. But the GDT concludes that the balance of the benefits, harms, and costs is too close to justify a general recommendation. |
| Evidence-Based, D |
The GDT recommends against the intervention. |
The GDT found at least fair evidence that the intervention is ineffective, or that harms or costs outweigh benefits. |
| Evidence-Based, I |
The GDT makes no recommendation for or against the intervention.† |
Evidence that the intervention is effective is lacking, of poor quality, or conflicting and the balance of benefits, harms, and costs cannot be determined. |
| Consensus-Based Recommendations |
| Consensus-Based |
The GDT recommends the intervention. |
The recommendation is based on the consensus of the GDT, typically in the setting of insufficient evidence. |
| Consensus-Based |
The GDT has determined that the intervention is an option. |
The recommendation is based on the consensus of the GDT, typically in the setting of insufficient evidence. |
| Consensus-Based |
The GDT recommends against the intervention. |
The recommendation is based on the consensus of the GDT, typically in the setting of insufficient evidence. |
| Note that most consensus-based recommendations will have evidence grade "Insufficient." For the rare consensus-based recommendations which have "Good" or "Fair" evidence, the evidence must support a different recommendation, because if the evidence were good or fair, the recommendation would usually be evidence-based. In this kind of consensus-based recommendation the evidence label should point this out, e.g., "Good," supporting a different recommendation. |
* All statements specify the population for which the recommendation is intended.
† At the discretion of the GDT, the recommendation may use the language, "option," but must list all the equivalent options.
