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FDA Consumer
magazine
November-December 2003 Issue
Combining the bone-building treatment parathyroid hormone (PTH) with alendronate, a drug that slows bone loss, produces no significant improvement in bone mineral density (BMD) beyond that produced by the individual drugs, researchers say.
Two studies reported in the Sept. 25, 2003, issue of The New England Journal of Medicine tested the effects of the drugs on BMD as measured in the spine and hip. BMD, a common indicator of bone health, is used to diagnose the bone-weakening disease osteoporosis, detect low bone mass before the disease develops, and help predict the risk of future fractures.
PTH, a medication used to treat osteoporosis, is taken by injection and has been shown to stimulate new bone formation. Alendronate is one of a group of drugs known as bisphosphonates, which reduce the activity that causes bone loss. Combining the two, scientists thought, might increase BMD more than either drug alone. However, these studies demonstrate that there is no advantage to giving the two drugs together. Moreover, the therapeutic effect of PTH is somewhat diminished when the two agents are combined.
"Both patients and physicians benefit from knowing how the combination compares to single drug treatment," says Stephen I. Katz, M.D., Ph.D., director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), one of the National Institutes of Health. "These findings could offer important clinical guidance to those at high risk for fractures and those who treat them."
One study, a randomized, blinded clinical trial involving 238 postmenopausal women with low hip or spine BMD, was carried out at four centers and coordinated by Dennis Black, M.D., of the University of California, San Francisco, and colleagues. Women in this study received a daily regimen of PTH, alendronate, or a combination of the two. After 12 months, results showed no significant benefit to combining treatments.
A second 30-month trial, done by Joel Finkelstein, M.D., and his colleagues at the Specialized Center of Research in Osteoporosis at Massachusetts General Hospital, involved 83 men between 46 and 85 years old with low BMD. Participants were treated with PTH, alendronate, and a combination of both. The Massachusetts researchers also found that the combination treatment did not have a positive effect on BMD scores.
Osteoporosis is marked by reduced bone strength that predisposes a person to an increased risk of fractures. The disorder is a major health risk for 28 million Americans. In the United States today, 10 million people already have osteoporosis and 18 million more have low bone mass, placing them at increased risk for the disease. Alendronate is the active ingredient in the prescription drug Fosamax. The medication Forteo contains PTH.
The studies were supported by NIAMS, the National Institute of Diabetes and Digestive and Kidney Diseases, and the National Center for Research Resources, all part of the Department of Health and Human Services' National Institutes of Health.
Women trying to lose weight can benefit as much from a moderate physical activity as from an intense workout, according to researchers at the National Heart, Lung, and Blood Institute (NHLBI).
Prior studies have focused on short-term weight loss, and data on the optimal degree and amount of physical activity for long-term weight loss had been lacking, the researchers say.
Their study, "Effect of Exercise Dose and Intensity on Weight Loss in Overweight, Sedentary Women: A Randomized Trial," appears in the Sept. 10, 2003, issue of the Journal of the American Medical Association (JAMA).
The exercise dose and intensity trial involved 201 overweight, but otherwise healthy, women ages 21 to 45. All received reduced-calorie meals in addition to being randomly assigned to one of four physical activity regimens, which varied by intensity and duration. The regimens consisted of either a moderate- or vigorous-intensity physical activity performed for either a shorter (2.5 to 3.5 hours per week) or longer (3.5 to 5 hours per week) duration. The physical activity consisted primarily of brisk walking, and the regimens burned about 1,000 or 2,000 calories per week.
Women in all four groups lost a significant amount of weight--about 13 to 20 pounds--and maintained their weight loss for a year. They also improved their cardiorespiratory fitness. However, the amount of weight lost or fitness improvement was not different among the four groups.
The same issue of JAMA includes an article on recreational physical activity and breast cancer risk. The study, based on data from the Women's Health Initiative's Observational Study, found that increased physical activity was associated with a reduced risk for breast cancer in postmenopausal women. Longer duration physical activity gave the most benefit, but the physical activity did not need to be strenuous to reduce breast cancer risk.