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Clinical Practice Guideline for Osteoporosis Screening and Treatment

Osteoporosis is the most common bone disease in humans. It is characterized by low bone mass, microarchitectural deterioration, comprised bone strength, and an increase in the risk of fracture. Osteoporosis is often defined clinically by an intermediate outcome, low bone mineral density (BMD).

Osteoporosis is a major public health threat for 28 million Americans, 80% of whom are women. In the U.S. 10 million individuals already have osteoporosis and 18 million more have more have low bone mass, placing them at increased risk for this disease. One out of every two women and one in eight men over 50 will have an osteoporosis-related fracture in their lifetime.

Risk factors leading to a more rapid onset of osteoporosis

Aging - Over age 65

Low body weight (< about 127lbs)

Personal history of fracture as an adult

History of fragility fracture in a first-degree relative

Current smoking

Use of oral corticosteroid therapy for more than 3 months

Alcohol in amounts >2 drinks per day

Impaired vision

Estrogen deficiency at an early age (<45yrs)

Dementia

Poor health/frailty

Recent falls

Low calcium intake (lifelong)

Low physical activity

Testosterone depletion in men

 

After menopause, all women should be evaluated clinically for osteoporosis risk in order to determine the need for BMD testing. In general, the more risk factors a woman has, the greater her risk of fracture.

Medical Conditions that may be associated with an increased risk of osteoporosis

AIDS/HIV

Hyperparathyroidism

Pernicious anemia

Amyloidosis

Hypogonadism, primary and secondary (e.g., amenorrhea)

Rheumatoid arthritis

Ankylosing spondylitis

Hypophosphatasia

Severe liver disease, especially primary

biliary cirrhosis

Chronic obstructive pulmonary disease

Idiopathic scoliosis

Spinal cord transsection

Congenital porphyria

Inadequate diet

Sprue

Cushing’s syndrome

Inflammatory Bowel Disease

Stroke (CVA)

Eating disorders (e.g., anorexia nervosa)

Insulin-dependent diabetes mellitus

Thalassemia

Female athlete triad

Lymphoma and leukemia

Thyrotoxicosis

Gastrectomy

Malabsorption syndromes

Tumor secretion of parathryroid hormone-related peptide

Gaucher’s Disease

Mastocytosis

Weight loss

Hemochromatosis

Multiple myeloma

Hemophilia

Multiple sclerosis

 

Drugs that may be associated with reduced bone mass in adults

Aluminum

Gonadotropin-releasing hormone agonists

Progesterone, parenteral, long-acting

Anticonvulsants (Phenobarbital, phenytoin)

Immunosuppressants

Supraphysiologic thyroxine doses

Cytotoxic drugs

Lithium

Tamoxifen (premenopausal use)

Glucocorticosteroids and adrenocorticotropin

Long-term heparin use

Total parenteral nutrition

 

Universal screening of bone mineral density (BMD) is recommended for

All women aged 65 and older regardless of risk factors.

Younger postmenopausal women with one or more risk factors (other than being white, postmenopausal, and female).

Postmenopausal women who present with fractures (to confirm diagnosis and determine disease severity).

Individuals with vertebral abnormalities. . Individuals receiving, or planning to receive, long term glucocorticoid (greater than 90days) therapy.

Individuals with primary hyperparathyroidism .

Individuals being monitored to assess the response of efficacy of an approved osteoporosis therapy.

 

* See attached Screening form utilized by Mercy Family Pharmacy

In using bone densitometry to diagnose osteoporosis, the results are reported as T-scores. The T score is the number of standard deviations from young normal controls. The Z score compares age-matched control patients. Fracture risk is determined by comparison to young normal controls. The diagnostic criteria are derived from the World Health Organization criteria for postmenopausal women. Osteoporosis is diagnosed if there is any fragility fracture or if the bone density shows a T score less than or equal to –2.5 at any site (lumbar spine, femoral neck, greater trochanter, or total hip). BMD T score less than or equal to –1.0 but greater than –2.5 is considered to be osteopenic. Normal bone density is a T score greater than –1.0.

The treatment criteria for osteoporosis are based on guidelines from the National Osteoporosis Foundation.

If a patient has screening and it is negative for osteoporosis, encourage healthy lifestyle including calcium and vitamin D supplementation and exercise, and consider rescreening in two to five years based on risk factors and life style changes.

 If a patient undergoes screening and is osteopenic, with a T score less than or equal to –1.0 but greater than –2.0, discuss lifestyle changes, prophylaxis and consider treatment. Rescreen in two to three years.

If a patient undergoes screening and is found to have osteopenia/osteoporosis, with a T score less than –2.0 or less than –1.5 with other risk factors for fracture (see table page 1-medical conditions that may be associated with an increased risk of osteoporosis), encourage necessary life style changes, including Calcium, Vitamin D, exercise, discuss eliminating any risk factors possible and consider medication management.

 In dealing with fracture risk and bone density, it is important to understand that fracture risk is a continuous variable and the application of diagnostic criteria based on T scores is an artificial construct. Also, it is important to understand that some fractures will occur in patients with a T score >-2.5, and some patients who are have osteoporotic bone densities (T score < -2.5) will not have any fractures at all.

Some patients (i.e., greater than 70 years old with multiple risk factors) are at sufficiently high

risk of osteoporosis that medication management is warranted without BMD testing.

 

Treatment Options

Lifestyle and dietary changes . Regular exercise program including weight-bearing and muscle-strengthening exercises. . Avoidance of tobacco use and excessive alcohol intake. . Adequate intake of elemental calcium (at least 1200 - 1500 mg/day, including supplements if necessary). . Adequate intake of vitamin D (400-800 IU/day for individuals at risk of deficiency).

 

Pharmacologic Options

1. For individuals who are candidates for medication management in addition to therapeutic  lifestyle changes, medication options include raloxifene, the bisphosphonates and  calcitonin.   Raloxifene (Evista.) is a selective estrogen receptor modulator (SERM) and may be  used in postmenopausal women. This drug does not cause menses or breast or  uterine hyperplasia. It may also decrease breast cancer and heart disease risk. It has a  favorable effect on lipid profiles. These are retrospective findings and prospective  studies are underway. Potential side effects include worsening of hot flashes and  raloxifene has the same relative risk for venous thrombotic events as estrogen. Some  women complain of leg discomfort, the cause of which is unknown and does not appear to be due to thrombosis.  

 

 The bisphosphonates include alendronate (Fosamax.) and risedronate (Actonel.).  Both agents reduce vertebral and hip fractures in primary postmenopausal  osteoporosis, and they prevent bone loss and decrease hip fractures in glucocorticoid-induced osteoporosis. Alendronate is approved for use in men. Both drugs are available as once-weekly preparations. These drugs are poorly absorbed and have potential GI side effects, therefore directions for use must be followed  exactly. Gastrointestinal problems secondary to these medications include  esophagitis, gastritis, and ulcers.

 Calcitonin (Miacalin.) is a naturally occurring hormone involved in calcium regulation and bone metabolism. In women who are more than 5 years beyond  menopause, calcitonin slows bone loss, increases spinal bone density, and, according  to anecdotal reports, may relieve the pain associated with bone fractures. Calcitonin  reduces the risk of spinal fractures but has not been shown to decrease the risk of  non-spine fractures. While it does not affect other organs or systems in the body,  injectable calcitonin may cause an allergic reaction and unpleasant side effects  including flushing of the face and hands, urinary frequency, nausea and a skin  rash. Side effects for nasal calcitonin are not common but may include nasal  irritation, backache, bloody nose, and headaches.

 In November 2002, the FDA approved Forteo (teriparatide or parathyroid hormone  1-34). In single subcutaneous dosing daily, it affects formation of bone through  stimulation of osteoblastic activity. It is not widely used (verus: Thus far it does not  appear to have a better therapeutic effect than the bisphosphonates and raloxifene  and as yet is not widely used) . It may promote development of bone tumors and is  contraindicated in patients with Paget’s disease of bone, in growing children with  open epiphyses, and in patients who may have had skeletal irradiation for cancer.  Teriparitide has been approved for use in individuals who have osteoporosis and are  at high risk for fracture, and for individuals who have failed or are intolerant of other  therapies.  ***Fortéo. is not on the MAHP formulary as of 9/04***.