The reason for the explosion: drugs to treat osteoporosis. After all, what's the point in diagnosing a woman if there's nothing you can do for her? But in 1995, the U.S. Food and Drug Administration (FDA) approved Fosamax (alendronate), the first drug shown to increase bone mass and significantly reduce the risk of fractures in women who already have osteoporosis. It was followed a few years later by Evista (raloxifene), part of a new class of drugs called SERMS, or selective estrogen receptor modulators, compounds that provide estrogen's bone-protecting benefits without many of its cancer-causing risks, and Actonel (risedronate) another drug in the same class as Fosamax, called bisphosphonates.
And a good thing, too, since that old standby for osteoporosis prevention and treatment--hormone replacement therapy--has been called into question in recent months as data from the Women's Health Initiative (WHI) trials found one form of estrogen slightly increased a woman's risk of invasive breast cancer and heart disease. (8) Since then, the FDA has attached a warning to all estrogen products advising health care professionals to prescribe them at the lowest dose and for the shortest possible duration. (9)
Still, the WHI study did find that the combination estrogen/progestin protected women against hip fractures. But given the risks and clearly safer alternatives, few physicians are prescribing it today for bone health, says Felicia Cosman, MD, clinical director for the National Osteoporosis Foundation.
The newest drug for osteoporosis, approved in November 2002, is Forteo (teriparatide). Consisting of a portion of the human parathyroid hormone, which helps bone use calcium and phosphate, it is the first approved drug that not only reduces fracture risk, but actually stimulates new bone formation. "There are people who are so excited about the availability of Forteo they're talking about the 'cure' of osteoporosis," says Dr. Schwartz. It costs about $6,000 a year, and requires daily injections.
(1.) NIH Consensus Statement: Osteoporosis Prevention, Diagnosis and Therapy. March 27-29, 2000.
(2.) Women's Complete Health Book, American Women's Medical Association, the Philip Leif Group, 1995
(3.) Feskanich D, Willett W. Colditz G. Walking and leisure-time activity and risk of hip fracture in postmenopausal women. JAMA. 2002 Nov 13;288(18):2300-6.
(4.) Turner LW, Bass MA, Ting L, Brown B. Influence of yard work and weight training on bone mineral density among older U.S. women. J Women Aging. 2002;14(3-4):139-48.
(5.) Osteoporosis: Progress and Prevention. National Institutes of Health. 2000. www.niams.nih.gov
(6.) Screening for Osteoporosis in Postmenopausal Women, ACHQ, September2002, http://www.ahrq.gov
(7.) Once is Enough: A Guide to Preventing Future Fractures, Notional Institutes of Health, revised January 2003. www.osteo.org
(8.) Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial. JAMA. 2002 Jul 17;288(3):321-33.
(9.) FDA Approves New Labels for Estrogen and Estrogen with Progestin Therapies for Postmenopausal Women Following Review of Women's Health Initiative Data. FDA Talk Paper. Jan. 8, 2003.
(10.) Medications to Prevent and Treat Osteoporosis, National Osteoporosis Foundation fact sheet, www.nof.org
(11.) Kids and their bones. National Institutes of Health. www.niams.nih.gov
(12.) Sanghavi, Darshak. A Map of the Child: A Pediatrician's Tour of the Body. Henry Hold, 2003.
(13.) Calcium Crisis, The Ups & Downs of Adolescence, June 2000. www.ianr.unl.edu
(14.) COC Fact Book, 2002.
(15.) Dietary Reference In takes for Calcium, Phosphorus, Magnesium, Vitamin D, and Fluoride ore available from the National Academy Press, August 1997.
PHARMACEUTICAL TREATMENTS FOR OSTEOPOROSIS (10) Class of Bone Medication Benefits Bisphosphonates. Reduces bone loss, increases Brand name: bone density and reduces Fosamax the risk of spine, wrist and (alendronate) and hip fractures. Actonel (risedronate) Selective estrogen Increases bone mass and receptor modulator reduces the risk of spine (SERM). Brand name: fractures. Evista (raloxifene) Calcitonin. In women who are more Brand name: than 5 years beyond Miacalcin menopause, calcitonin slows bone loss, increases spinal bone density and may relieve the pain asso- ciated with bone fractures. Parathyroid hormone. Stimulates new bone for- Brand name: mation and increases Forteo bone mineral density. (teriparatide) Fracture reduction noted in postmenopausal women, Class of Additional Medication Benefits Bisphosphonates. Also approved for treat- Brand name: ment of glucocorticoid- Fosamax induced osteoporosis in (alendronate) and men and women. Fosamax Actonel approved for the treat- (risedronate) ment of osteoporosis in men. Selective estrogen May reduce the risk of receptor modulator estrogen-dependent (SERM). Brand name: breast cancer by 65 Evista (raloxifene) percent over 4 years. Calcitonin. Brand name: Miacalcin Parathyroid hormone. Brand name: Forteo (teriparatide) Class of Potential Medication Side Effects Bisphosphonates. Side effects are uncommon Brand name: but may include abdominal or Fosamax musculoskeletal pain, nausea, (alendronate) and heartburn, or irritation of the Actonel esophagus. (risedronate) Selective estrogen Uncommon but may include receptor modulator deep vein thrombosis and hot (SERM). Brand name: flashes associated with estro- Evista (raloxifene) gen therapy. Calcitonin. Injectable calcitonin may cause Brand name: an allergic reaction and flushing Miacalcin of face and hands, frequent urination, nausea, skin rash. Side effects for nasal calcitonin may include nasal irritation, backache, bloody nose and headaches. Parathyroid hormone. Side effects include nausea, leg Brand name: cramps and dizziness. The drug Forteo also carries an FDA "black box" (teriparatide) warning: slightly increased risk of bone cancer in animals. Class of Medication Administration Information Bisphosphonates. Should be taken on an empty stomach Brand name: with a full 6- to 8- ounce glass Fosamax of water. Manufacturer recommends (alendronate) and taking this medication first thing Actonel in the morning, at least 30 to 60 (risedronate) minutes before any food, beverages or medications. To minimize side effects remain in an upright position for at least 30 minutes after taking medication. Alendronate can be taken daily or weekly. Selective estrogen Raloxifene is taken in pill form, receptor modulator once a day with or without meals. (SERM). Brand name: Evista (raloxifene) Calcitonin. Must be taken as either an Brand name: injection or nasal spray. Miacalcin Parathyroid hormone. Self-administered as a daily Brand name: injection for up to 24 months. Forteo (teriparatide)