Treating osteoporosis.

In 1995, there were 750 bone density machines in use in the United States. Today, there are between 12,000 and 14,000, says Elliott Schwartz, MD, co-medical director of the Foundation for Osteoporosis Research and Treatment (FORE).

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.

References

(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)