Synopsis of Major Recommendations to the Physician
- Counsel all women on the risk of osteoporosis and related fractures.
- Advise all patients to consume adequate amounts of calcium (at least 1200 mg per day, including supplements if necessary) and vitamin D (400 to 800 IU per day for individuals for risk of deficiency).
- Recommend regular weight-bearing and muscle-strengthening exercise to reduce the risk of fall and fractures.
- Advise patients to avoid tobacco smoking and excessive alcohol intake.
- Recommend bone mineral density (BMD) testing to all women aged 65 and older.
- Recommend BMD testing to younger postmenopausal women who have one or more risk factors (other than being white, postmenopausal, and female).
- Recommend BMD testing to postmenopausal women who have suffered a fragility fracture to confirm the diagnosis and determine disease severity.
- Initiate therapy to reduce fracture risk in postmenopausal women with BMD T-scores by central dual x-ray absorptiometry (DXA) below -2 in the absence of risk factors and in women with T-scores below -1.5 if one or more risk factors are present.
- Consider postmenopausal women with vertebral or hip fractures candidates for osteoporosis treatment.
- Current pharmacologic options for osteoporosis prevention and/or treatment are bisphosphonates (alendronate and risedronate), calcitonin, estrogens and/or hormone therapy, parathyroid hormone (PTH 1-34), and raloxifene.
Universal Recommendations for all Individuals
- Advise all patients to consume adequate amounts of calcium (at least 1200 mg/day) and vitamin D (400-800 IU/day).
- Recommend regular weight-bearing and muscle-strengthening exercise and balance-training exercises to reduce the risk of falls and fractures.
- Advise all patients to avoid tobacco smoking and alcohol intake in excess of two drinks per day.
Additional Recommendations for Postmenopausal Women
- Counsel all women on the risk of osteoporosis and related fractures. Osteoporosis is a 'silent' risk factor for facture just as hypertension is for stroke.
- Recommend BMD testing to all women aged 65 and older.
- Recommend BMD testing to younger postmenopausal women who have one or more risk factors (other then being white, postmenopausal, and female).
- Recommend BMD testing to postmenopausal women who have suffered a facture as an adult to confirm diagnosis and determine disease severity.
- Initiate therapy to reduce fracture risk in postmenopausal women with BMD T-scores by dual x-ray absorptiometry (DXA) below -2 in the absence of risk factors.
- Initiate therapy to reduce fracture risk in postmenopausal women with BMD T-scores by DXA below -1.5 if one or more risk factors are present.
- Consider postmenopausal women with vertebral or hip factures candidates for osteoporosis treatment.
Major Risk Factors for Osteoporosis and Related Fracture in Caucasian Postmenopausal Women:
- Personal history of fracture as an adult
- History of fragility facture in a first-degree relative
- Low body weight (<about 127 lbs)
- Current smoking
- Use of oral corticosteroid therapy for more than 3 months
Additional Risk Factors:
- Impaired vision
- Estrogen deficiency at an early age (<45 yrs)
- Dementia
- Poor health/frailty
- Recent falls
- Low calcium intake (lifelong)
- Low physical activity
- Alcohol in amounts >2 drinks per day
Defining Osteoporosis by World Health Organization (WHO) BMD Criteria
The World Health Organization (WHO) has established the following definitions based on bone mass measurement at the spine, hip, or wrist in white postmenopausal women:
Normal: Bone mineral density (BMD) is within 1 standard deviation (SD) of a "young normal" adult (T-score at -1.0 and above).
Low bone mass (osteopenia): BMD is between 1 and 2.5 SD below that of a "young normal" adult (T-score between -1 and -2.5).
Osteoporosis: BMD is 2.5 SD or more below that of a "young normal" adult (T-score at or below -2.5). Women in this group who have already experienced one or more fractures are deemed to have severe or "established" osteoporosis.
Although these definitions are necessary to establish the prevalence of osteoporosis, they should not be used as the sole determinant of treatment decisions.
Who Should Be Tested?
The decision to test for BMD should be based on an individual's risk profile, and testing is never indicated unless the results could influence a treatment decision.
BMD testing should be performed on:
- All women aged 65 and older regardless of risk factors
- Postmenopausal women under age 65 with one or more risk factors in addition to being white, postmenopausal, and female
- Postmenopausal women who present with factures
Who Should Be Treated?
- In the absence of risk factors, initiate therapy to reduce fracture in women with BMD T-scores below -2.0 by DXA of the hip.
- With one or more risk factors, initiate therapy in women with BMD T-scores below -1.5 by DXA of the hip.
- Initiate therapy in women with a prior vertebral or hip fracture.
Pharmacologic Options
The following medications are approved by the Food and Drug Administration (FDA) for the prevention and/or treatment of osteoporosis. They are presented in alphabetical order. For detailed information, please refer to the complete product information on each medication.
Bisphosphonates
- Alendronate sodium (brand name Fosamax®) is approved for prevention (5-mg daily dose or 35-mg weekly dose) and treatment (10-mg daily dose and 70-mg weekly dose) of postmenopausal osteoporosis. Alendronate reduces the incidence of spine, hip, and nonspine fractures by 50%.
- Risedronate sodium (brand name Actonel®) is approved for prevention and treatment (5-mg daily dose and 35-mg weekly dose) of postmenopausal osteoporosis. Risedronate reduces the incidence of spine fractures by 40% and hip and nonspine fractures by 30%.
- Possible side effects include upper gastrointestinal disorders such as dysphagia, esophagitis, and esophageal or gastric ulcer. To reduce the risk of side effects, take these medications on an empty stomach with 8 oz. of tap water. Remain sitting or standing for at least 30 minutes and refrain from eating or drinking during this time.
Calcitonin (brand name Miacalcin®) is approved for treatment of osteoporosis in women who are at least 5 years postmenopausal. It is delivered as a single daily intranasal spray or injection. Calcitonin reduces the risk of spine fractures by 21%. Calcitonin is well tolerated but may cause rhinitis or, rarely, epistaxis.
Estrogen/hormone therapy (ET/HT available in a variety of brands) is approved for the prevention of postmenopausal osteoporosis. Women who have not had a hysterectomy require HT, which contains progestin to protect the uterine lining. While ET/HT reduces the risk of spine and hip fractures by 34%, its use resulted in increased risk for breast cancer, heart attack, stoke, and venous thromboembolism. On the basis of results from the Women's Health Initiative Study, the FDA has made the following recommendations:
- ET/HT should be used in the lowest doses possible for the shortest period of time to relieve menopausal symptoms.
- When considering ET/HT for prevention of osteoporosis, consider all available medications prior to making a decision.
Parathyroid hormone (PTH teriparatide) (brand name Fortéo®) is approved for the treatment of osteoporosis in postmenopausal women at risk for osteoporotic fractures. PTH is an anabolic peptide that increases bone density. It reduces the risk of spine fractures by 65% and nonspine fractures by 54% after an average of 18 months of therapy. PTH is administered as a daily subcutaneous injection. Side effects include leg cramps and dizziness. Long-term safety is unknown, so use is limited to 2 years.
Raloxifene (brand name Evista®) is a selective estrogen receptor modulator that is approved for the prevention and treatment of postmenopausal osteoporosis. Raloxifene reduces the risk of spine factures by 40%. Possible side effects include hot flashes and deep vein thromboses. Raloxifene appears to reduce the risk of estrogen-dependent breast cancer.
NOF recommends that osteoporosis be treated with therapies specifically approved by the FDA for this purpose.
