FDA-Approved Medications for Osteoporosis Prevention and/or Treatment
Treatment of osteoporosis should always include a well-balanced diet, adequate intake of calcium and vitamin D, regular exercise, safety precautions for fall prevention, avoidance of tobacco products and limited consumption of alcohol. However, if osteoporosis is diagnosed, these important lifestyle modifications alone are often not enough; medication may be needed to stop further bone loss and to prevent broken bones. The Federal Drug Administration (FDA) has approved the following medications, listed in alphabetical order, for osteoporosis prevention and/or treatment.
Bisphosphonates. There are two bisphosphonates, alendronate and risedronate, approved for used in the prevention and treatment of osteoporosis. The bisphosphonates work only on the bone and do not affect the heart, breast, uterus or other parts of the body. Like all medications, the bisphosphonates may have side effects that should be discussed with your doctor. The side effects of bisphosphonates may include heartburn and irritation of the esophagus but can usually be avoided by taking the medication properly. Bisphosphonates must be taken first thing in the morning on an empty stomach with a full glass of tap water. Do not take these medications with any other beverages such as orange juice, milk, or coffee. After taking this medication, you must remain upright (in a sitting or standing position) and avoid bending over or lying down for at least 30 minutes.
- - Alendronate (Fosamax) is FDA-approved for the prevention or treatment of osteoporosis in postmenopausal women and men. In addition, alendronate is approved for the treatment of women and men with osteoporosis resulting from the long-term use of steroid medications such as prednisone or cortisone. For osteoporosis prevention, alendronate is available as a 5mg tablet taken daily or a 35mg tablet taken once a week. For osteoporosis treatment, alendronate is approved as a 10mg tablet taken daily or a 70mg tablet taken once a week. Clinical studies show alendronate prevents bone loss and reduces the risk of all osteoporosis-related fractures (fractures of the spine and other non-spine areas including the hip) in patients with osteoporosis.
- - Risedronate (Actonel) is FDA-approved as a 5mg tablet taken daily or as a 35mg tablet taken once a week for osteoporosis prevention and treatment in postmenopausal women. In addition, risedronate may be used to treat women and men with osteoporosis resulting from the use of long-term steroid medications or to prevent osteoporosis related to steroid use. Risedronate prevents bone loss and reduces the risk of all osteoporosis-related fractures (fractures of the spine and other non-spine areas) in patients with osteoporosis.
Calcitonin (Miacalcin) is a hormone that is usually prescribed as a nasal spray. It is also available as an injection. Calcitonin is approved for the treatment of osteoporosis in women who have been postmenopausal for five or more years. Calcitonin can decrease bone loss in the spine, but is the least potent of all the approved medications. Studies have shown that calcitonin reduces the risk for spine fractures in the older woman, but to a lesser extent than other agents. There is no proof that calcitonin reduces fractures anywhere else besides the spine. Calcitonin may have some pain relief properties following spine fracture. Like alendronate and risedronate, calcitonin affects bone only and will not change your risk of other diseases. The possible side effects tend to be mild (runny nose, nose bleeds and nose pain) and should be discussed with a medical professional.
Estrogen Therapy and Hormone Therapy are FDA-approved for the prevention of osteoporosis in postmenopausal women. Estrogen therapy (ET) is available in either tablet form or in a skin patch. If you have an intact uterus, your doctor will probably prescribe the hormone progestin in combination with estrogen. Estrogen plus progestin is called hormone therapy (HT).
ET or HT is often prescribed for the relief of the most common menopausal symptoms experienced by women including hot flashes, night sweats and other genitourinary symptoms including vaginal dryness. Both ET and HT protect against the rapid loss of bone that occurs in the first five years after menopause. A woman can lose up to 15% of her lifetime skeleton without estrogen protection. HT reduces the risk for fractures including hip fractures and also decreases colorectal cancer occurrence but increases the risk for breast cancer, heart disease, blood clots and stroke. It is likely that estrogen alone (ET) also reduces fractures but the magnitude of fracture reduction as well as it’s other benefits and risks are currently being investigated.
For many women, the benefits of using ET/HT for osteoporosis prevention may not outweigh the risks. You and your doctor, taking into consideration your menopausal status as well as your personal and family history of osteoporosis, heart disease, and certain cancers, must carefully weigh the benefits and risks of taking or continuing to take ET or HT. In general, ET/HT should be used for the shortest period of time possible. If your medical professional prescribes ET or HT, it is important to discuss how long you should remain on the medication. It is important to understand that the same rapid loss of bone (up to 15% over 5 years) will occur when you stop taking ET or HT, no matter how long you have been on it. When choosing ET/HT for osteoporosis prevention, it is important to understand that there are alternative medications to prevent bone loss and reduce the risk for osteoporosis-related fractures.
Raloxifene (Evista) is FDA-approved as a 60mg tablet for the prevention and treatment of osteoporosis in postmenopausal women. Raloxifene improves bone mass throughout the skeleton and reduces the risk for spine fracture. Clinical studies are currently investigating the effect of raloxifene on hip and other non-spine fractures. Raloxifene may have potential effects on other parts of the body besides your bones; such as the heart, breast and uterus. The effect of raloxifene on the heart is unclear but a large trial is in progress that will give us more information. Studies thus far have indicated that raloxifene may have a protective effect on breast tissue. Raloxifene may have potential adverse effects, such as an increase in hot flashes, an increased risk for blood clots in the leg veins or the lungs (similar to estrogen), leg cramps and fluid retention. Like all medications, it is important to discuss all of the potential benefits and risks of taking this medication with your medical professional.
Teriparatide (Forteo)is only available as an injection. It is a form of human parathyroid hormone (PTH) approved for the treatment of osteoporosis in postmenopausal women and men who are at high risk for fracture. Individuals at high risk for fracture include postmenopausal women and men who have had one or more osteoporotic fractures, who have very low bone mineral density or who have not tolerated or responded successfully to previous medications for osteoporosis. Teriparatide is not to be used to prevent osteoporosis or to treat patients who are not at high risk for fracture. Clinical studies have shown that teriparatide increases bone mass, restores the internal architecture of osteoporotic bone and reduces the risk for spine and other fractures in postmenopausal women.
The most common side effects are dizziness and leg cramps. Elevations in blood calcium and urine calcium can also occur. Side effects such as nausea, joint and muscle pains and general weakness are rare. The safety and benefits of teriparatide have not been evaluated beyond two years, so treatment for longer than two years is not recommended.
(c) Helen Hayes Hospital/NYS Department of Health - 11/03
