Prevention and treatment of osteoporosis

Adequate calcium, vitamin D, appropriate exercise and, in some cases, medication are important for maintaining bone health. Currently, bisphosphonates (alendronate and risedronate), calcitonin, estrogens, parathyroid hormone and raloxifene are approved by the US Food and Drug Administration (FDA) for the prevention and/or treatment of osteoporosis.

The bisphosphonates (alendronate and risedronate), calcitonin, estrogens and raloxifene affect the bone remodeling cycle and are classified as anti-resorptive medications. Bone remodeling consists of two distinct stages: bone resorption and bone formation. During resorption, special cells on the bone's surface dissolve bone tissue and create small cavities. During formation, other cells fill the cavities with new bone tissue. Usually, bone resorption and bone formation are linked so that they occur in close sequence and remain balanced. An imbalance in the bone remodeling cycle causes bone loss that eventually leads to osteoporosis and fracture risk. Anti-resorptive medications slow or stop the bone-resorbing portion of the bone-remodeling cycle but do not slow the bone-forming portion of the cycle. As a result, new formation continues at a greater rate than bone resorption, and bone density may increase over time.

Teriparatide, a form of parathyroid hormone, is a newly approved osteoporosis medication. It is the first osteoporosis medication to increase the rate of bone formation in the bone remodeling cycle.

Antiresorptive Medications

For more detailed information on the actions, administration and possible side effects for each of the following medications, please consult the Package Insert, available on-line and at pharmacies.

The information provided here regarding particular medications is intended solely for general information and should NOT be relied upon for any particular diagnosis, treatment, or care. Inclusion in this list does not imply an endorsement by NOF of any particular medication or manufacturer.

For more detailed information on the actions, administration and possible side effects for each of the following medications, please consult the Package Insert, available on-line and at pharmacies.

Bisphosphonates
Alendronate Sodium (brand name Fosamax®)

Alendronate is approved for both the prevention (5 mg per day or 35 mg once a week) and treatment (10 mg per day or 70 mg once a week) of postmenopausal osteoporosis. Alendronate reduces bone loss, increases bone density and reduces the risk of spine, wrist and hip fractures.

Alendronate also is approved for treatment of glucocorticoid-induced osteoporosis in men and women as a result of long-term use of these medications (i.e., prednisone and cortisone) and for the treatment of osteoporosis in men.

Risedronate Sodium (brand name Actonel®)

Risedronate is approved for the prevention and treatment of postmenopausal osteoporosis. Taken daily (5 mg dose) or weekly (35 mg dose), risedronate slows bone loss, increases bone density and reduces the risk of spine and non-spine fractures.

Risedronate also is approved for use by men and women to prevent and/or treat glucocorticoid-induced osteoporosis that results from long-term use of these medications (i.e., prednisone or cortisone).

Administration and Side Effects of Bisphosphonates

Side effects for alendronate and risedronate are uncommon but may include abdominal or musculoskeletal pain, nausea, heartburn, or irritation of the esophagus.

Alendronate and risedronate must be taken on an empty stomach, first thing in the morning, with eight ounces of water (no other liquid), at least 30 minutes before eating or drinking. Patients must remain upright during this 30-minute period.

Calcitonin
(Brand name Miacalcin®)

Calcitonin 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. Studies on fracture reduction are on going. Because calcitonin is a protein, it cannot be taken orally as it would be digested before it could work. Calcitonin is available as an injection (50-100 IU daily) or nasal spray (200 IU daily).

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.

Estrogen Therapy (ET) and Hormone Therapy (HT)
(Multiple brand names are available.)

Following analysis of the Women's Health Initiative study, the FDA made the following recommendations for all ET and HT preparations:

  • Prescribe lowest possible doses of ET/HT for the shortest period of time to manage symptoms of menopause;

  • Discuss alternative osteoporosis medications for women at risk for or diagnosed with osteoporosis.

Estrogen therapy (ET)/Hormone therapy (HT) is approved for the prevention of osteoporosis. ET has been shown to reduce bone loss, increase bone density in both the spine and hip, and reduce the risk of hip and spinal fractures in postmenopausal women. ET is administered most commonly in the form of a pill or skin patch that delivers a low dose of approximately 0.3 mg daily or a standard dose of approximately 0.625 mg daily and is effective even when started after age 70.

When estrogen is taken alone, it can increase a woman's risk of developing cancer of the uterine lining (endometrial cancer). To eliminate this risk, physicians prescribe the hormone progestin in combination with estrogen (hormone therapy or HT) for those women who have an intact uterus. ET/HT relieves menopause symptoms and has been shown to have a beneficial effect on bone health. Side effects may include vaginal bleeding, breast tenderness, mood disturbances and gallbladder disease.

The Woman's Health Initiative (WHI) study recently confirmed that one type of HT, Prempro®, reduced the risk of hip and other fractures as well as colon cancer. The WHI also confirmed that this HT is associated with a modest increase in the risk of breast cancer, strokes, heart attacks and venous blood clots.

A study from the National Cancer Institute (NCI) recently reported that long-term use of ET may be associated with a small increase the risk of ovarian cancer. However, a meta-analysis by the Centers for Disease Control (CDC) did not find an association of either ET or HT with ovarian cancer.

Raloxifene
(Brand name Evista®)

Raloxifene, 60 mg a day, is approved for the prevention and treatment of postmenopausal osteoporosis. It is from a class of drugs called Selective Estrogen Receptor Modulators (SERMs) that have been developed to provide the beneficial effects of estrogens without their potential disadvantages. Raloxifene increases bone mass and reduces the risk of spine fractures. Data are not yet available to demonstrate that raloxifene can reduce the risk of hip and other non-spine fractures.

Raloxifene appears to decrease the risk of estrogen-dependent breast cancer by 65% over 4 years.

While side effects were not common, those reported included hot flashes and deep vein thrombosis, the latter of which is also associated with estrogen therapy. Raloxifene is taken in pill form, once a day with or without meals.

Bone Forming Medications

Parathyroid Hormone
(Brand name Fortéo®)

Teriparatide, a form of parathyroid hormone, is approved for the treatment of osteoporosis in postmenopausal women and men who are at high risk for a fracture. This medication stimulates new bone formation and significantly increases bone mineral density. In postmenopausal women, fracture reduction was noted in the spine, hip, foot, ribs and wrist. In men, fracture reduction was noted in the spine, but there were insufficient data to evaluate fracture reduction at other sites. Teriparatide is self-administered as a daily injection for up to 24 months.

Side effects include nausea, leg cramps and dizziness.

To receive the latest scientific information on osteoporosis and ideas on how to better cope with this disease, please consider joining NOF as a member. Individual members of the National Osteoporosis Foundation ($15) receive our quarterly patient newsletter, Osteoporosis Report, and a copy of our 70-page comprehensive patient handbook, Boning Up on Osteoporosis. Several levels of health professional memberships are available. Join on-line today.

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