US FDA-APPROVED DRUGS FOR OSTEOPOROSIS
First posted July 14, 2002 Published Revision May, 2002
[Note: All material on this site is written by Dr. Nelson, unless noted otherwise.
This material was not written by Dr. Nelson, but by the author indicated in the document.]
National Osteoporosis Foundation
Update on Medications: May, 2002
U.S. Food and Drug Administration-approved pharmacologic options for osteoporosis prevention and/or treatment include, in alphabetical order,
bisphosphonates (alendronate, risedronate), calcitonin, estrogens (hormone replacement therapy) and selective estrogen receptor
modulators or SERMs (raloxifene).
Bisphosphonates
Alendronate
Brand name: Fosamax®
Alendronate is approved by the FDA for the prevention and treatment of osteoporosis in postmenopausal women. Controlled clinical trials utilizing
alendronate sodium indicate that over a 3 - 4 year period alendronate increases bone mass and reduces the incidence of fractures at the spine, hip and wrist by 50%.
Alendronate also is approved as a treatment to increase bone mass in men with osteoporosis. Additionally, the FDA has approved alendronate for the treatment of osteoporosis in both men and women as a result of prolonged glucocorticoid use.
The 5 mg daily dose and 35 mg weekly dose have been approved by the FDA for prevention of postmenopausal osteoporosis, and the 10 mg daily dose and 70 mg weekly dose have been approved for treatment in men and postmenopausal women.
Risedronate
Brand name: Actonel®
Risedronate sodium (5 mg daily dose and 35 mg weekly dose) is approved by the FDA for the prevention and treatment of postmenopausal osteoporosis. The 5mg daily dose also is approved for the prevention and treatment of glucocorticoid-induced osteoporosis in men and women.
Risedronate has been demonstrated in studies to increase bone mass in the spine and hip and reduce the risk of spine and non-spine fractures by 40-50% over a 3-5 year period.
Side Effects and Administration of Bisphosphonates
Side effects of bisphosphonates may include upper gastrointestinal disorders such as dysphagia, esophagitis, and esophageal or gastric ulcer.
Alendronate and risedronate must be taken on an empty stomach, first thing in the morning, with 8 ounces of water (no other liquid), at least 30 minutes before eating or drinking. Patients should remain upright during this interval as well.
Calcitonin
Brand name: Miacalcin®, Calcimar®
Salmon calcitonin is FDA-approved for the treatment of osteoporosis in women who are at least 5 years postmenopausal. It is delivered as a single daily
intranasal spray that provides 200 international units (IU) of the drug. Subcutaneous administration by injection also is available. Results from a single controlled clinical trial indicated that calcitonin may decrease osteoporotic vertebral fractures by approximately 35% but does not reduce the risk of
non-spine fractures.
Calcitonin is generally considered to be a safe but somewhat less effective intervention for osteoporosis. It may be used as an alternative to other agents for
patients who meet the criteria for other osteoporosis treatments but are unwilling to take them or have found treatment unsuccessful.
Estrogen/Hormone Replacement Therapy (ERT/HRT)
ERT brand names: e.g. Climara®, Estrace®, Estraderm®, Estratab®, Ogen®, Ortho-Est®, Premarin®, Vivelle®
HRT brand names: e.g. ActivellaTM, Femhrt®, Premphase®, Prempro®
Estrogen/hormone replacement therapy (ERT/HRT) has been approved by the FDA for the prevention and management of osteoporosis. Epidemiological
studies of ERT/HRT indicate a 50% decrease in vertebral fractures and a 25% decrease in non-vertebral fractures with 5 years of use and an anticipated 50% decrease in all fractures with 10 or more years of use. Several randomized clinical trials suggest that estrogen protects against spine fractures. A meta-analysis of clinical trials suggests that ERT/HRT can reduce the risk of all non-spinal fractures in younger, menopausal women. However, for older women,
data do not confirm that ERT/HRT reduces the risk of non-spinal fractures, particularly hip fractures.
Women who have not had a hysterectomy require HRT, which contains progestin to protect the uterine lining. ERT/HRT is extremely effective at reducing
hot flashes and night sweats due to menopause.
ERT/HRT may be associated with a modest increase in risk of breast cancer with long-term use and can have significant side effects, including vaginal
bleeding, breast tenderness, mood disturbances and gallbladder disease. ERT/HRT also increases the risk of venous thromboembolism. The effect of
estrogen on heart disease is still being assessed, but recent studies indicate that estrogen may increase risk of cardiovascular events in people with established
coronary disease. There fore, women with known heart disease should not begin
ERT/HRT.
Raloxifene
Brand name: Evista®
This drug is in a class of compounds called selective estrogen receptor modulators (SERMs), which have been developed to provide the beneficial
effects of estrogens without their potential disadvantages. Raloxifene is approved by the FDA for both prevention and treatment of osteoporosis in postmenopausal women.
Raloxifene provides modest increases in bone mass and reduces the risk of vertebral fracture by 40-50%. Data are not yet available to demonstrate that
raloxifene can reduce the risk of non-vertebral fractures. Raloxifene appears to decrease the risk of estrogen-dependent breast cancer. Preliminary data show that raloxifene may reduce heart disease and stroke in women at high risk or who already have heart disease.
Raloxifene increases the risk of deep vein thrombosis to a degree similar to that observed with estrogen. In addition, because an increase in hot flashes is observed (~6% over placebo), raloxifene is not a treatment for menopausal symptoms.
Non-U.S. FDA Approved Drugs for Osteoporosis
The NOF does not advocate the use of drugs not approved by the U.S. FDA for prevention and treatment of osteoporosis. These drugs are listed for
information only. These non-approved agents include:
Calcitriol
This synthetic vitamin D analogue, which promotes calcium absorption, has been approved by the FDA for managing hypocalcemia and metabolic bone disease in renal dialysis patients. It is also approved for use in hypoparathyroidism, both surgical and idiopathic, and pseudohypoparathyroidism. No reliable data demonstrate a reduction of risk for osteoporotic fracture.
Other bisphosphonates (etidronate, tiludronate, pamidronate, ibandronate, zoledronate) These agents vary chemically from alendronate and risedronate but are in the same class of drug. At the time of publication, none is approved for prevention or treatment of osteoporosis. These medications are currently approved for a variety of conditions including Paget's Disease, hypercalcemia of malignancy, and myositis ossificans. Ibandronate, a bisphosphonate that can be given either intravenously or orally, and zoledronate, given intravenously, are also under evaluation for their effects on osteoporosis.
Parathyroid Hormone (PTH)
Intermittent injection of PTH acts as an anabolic (bone-building) agent which stimulates bone formation rather than reducing the rate of bone turnover. Clinical studies indicate that PTH can increase vertebral, femoral and total body bone mineral density and decrease the risk of vertebral and non-vertebral fractures. Final FDA approval of PTH for the treatment of osteoporosis is currently pending.
Sodium fluoride
Through a process that is still unclear, sodium fluoride stimulates the formation of new bone. The quality of bone mass thus developed is also uncertain, and the evidence that fluoride reduces fracture risk is conflicting and controversial.
Tibolone
A tissue-specific, estrogen-like agent which may reduce menopausal symptoms while avoiding stimulation of breast and uterine tissues. It is indicated in Europe for the treatment of vasomotor symptoms of menopause and for prevention of osteoporosis but is not currently approved for use in the United States.
Developed and published by the National Osteoporosis Foundation, 5/02
© 2002 National Osteoporosis Foundation
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