Correspondence
The Effect of Risedronate on the Risk of Hip Fracture in Elderly Women
N Engl J Med 2001; 344:1720-1721May 31, 2001
- Article
To the Editor:
The report by McClung et al. (Feb. 1 issue)1 is unconvincing, because information is not presented to show that the women in the treatment and placebo groups had similar clinical risk factors for hip fracture. This information should have been included in the table showing the base-line characteristics of the groups.
1 ReferencesPaul C. Royce, M.D., Ph.D.
9 Prospect Rd., Atlantic Highlands, NJ 077161
McClung MR ,Geusens P ,Miller PD , et al. Effect of risedronate on the risk of hip fracture in elderly women. N Engl J Med 2001;344:333-340
Full Text | Web of Science | Medline
To the Editor:
McClung et al. state that “complete follow-up data were available for 64 percent of the women.” In other words, follow-up data were incomplete for 36 percent, or 3324, of the 9331 women. One wonders how to interpret an estimated overall absolute difference in the incidence of hip fracture of 1.1 percentage points, or 42 women with fractures, in the light of such incomplete data. A slight preponderance of fractures among those lost to follow-up in the risedronate group could render the results inconclusive.
Robert L. Goodman, M.D.
Columbia University College of Physicians and Surgeons, New York, NY 10032To the Editor:
McClung et al. found that risedronate in addition to calcium and vitamin D reduced the risk of hip fracture in women 70 to 79 years old who were recruited on the basis of a low bone mineral density at the femoral neck. This suggests that screening for low bone mineral density followed by an appropriate treatment may be worthwhile even in elderly women, as long as they have a very low bone mineral density. To assess whether the incidence of hip fracture continues to rise when the bone mineral density decreases to very low values, even in very elderly women, we reanalyzed the data from a prospective cohort study of 7598 women 75 years old or older (the Epidémiologie de l'Ostéoporose [EPIDOS] study).1,2 The age-adjusted incidence of hip fracture increased from 5.7 per 1000 person-years among women with a T score of –2.5 or lower to 36.5 per 1000 person-years among women with a T score lower than –4. In the trial of risedronate conducted by McClung et al., no effect was observed among the women 80 years old or older. However, most women in this subgroup were enrolled on the basis of clinical risk factors only, and many did not have very low bone mineral density. In the EPIDOS study, among 4478 women 80 years old or older, 77 percent had one or more clinical risk factors.3 Of these, only 27 percent had a T score below –3. These results emphasize the need to measure bone mineral density at the femoral neck to identify elderly women in whom therapy to prevent fracture is appropriate.
3 ReferencesAnne-Marie Schott, M.D.
E. Herriot Hospital, 69437 Lyons CEDEX 03, FrancePatricia Dargent-Molina, Ph.D.
National Institute for Medical Research, 94807 Villejuif CEDEX, FrancePierre J. Meunier, M.D.
E. Herriot Hospital, 69437 Lyons CEDEX 03, France1
Schott AM ,Cormier C ,Hans D , et al. How hip and whole-body bone mineral density predict hip fracture in elderly women: the EPIDOS Prospective Study. Osteoporos Int 1998;8:247-254
CrossRef | Web of Science | Medline2
Mazess RB ,Barden H . Bone density of the spine and femur in adult white females. Calcif Tissue Int 1999;65:91-99
CrossRef | Web of Science | Medline3
Dargent-Molina P ,Favier F ,Grandjean H , et al. Fall-related factors and risk of hip fracture: the EPIDOS prospective study. Lancet 1996;348:145-149[Erratum, Lancet 1996;348:416.]
CrossRef | Web of Science | Medline
Author/Editor Response
Dr. McClung replies:
To the Editor: Dr. Royce raises an important point. The proportions of both the older and younger women with various risk factors were balanced among the treatment groups, so the observed treatment effect was not the result of differences in risk at base line. Dr. Goodman expresses appropriate concern about the potential effect of the incomplete follow-up of the elderly women in our study. The demographic characteristics with respect to the risk of fracture were very similar between the women for whom we had complete follow-up data and those for whom we did not. Using the observed incidence of hip fractures that occurred during follow-up, Dr. Goodman estimates that an additional 42 hip fractures would have been observed if all the women had been followed for three years. If we make the conservative assumption that there is no treatment effect in these women, these fractures would be proportionally distributed between the treatment groups, with 14 in the placebo group and 28 in the risedronate group. In this case, the reduction in the risk of hip fracture in the combined risedronate groups would have remained significant (risk reduction, 24 percent; 95 percent confidence interval, 3 percent to 41 percent; P=0.03).
The information provided by Dr. Schott and colleagues from their large observational study supports our findings that elderly women with fall-related risk factors do not necessarily have low bone density and may not be candidates for drug therapy to reduce the risk of hip fracture. Although bone mass decreases with advancing age, we cannot assume that all older women have osteoporosis.
Michael McClung, M.D.
Oregon Osteoporosis Center, Portland, OR 97213- Citing Articles (8)
Citing Articles
1
Joop P. van den Bergh, Tineke A. van Geel, Piet P. Geusens. (2012) Osteoporosis, frailty and fracture: implications for case finding and therapy. Nature Reviews Rheumatology
CrossRef2
Solomon Epstein. (2006) Update of current therapeutic options for the treatment of postmenopausal osteoporosis. Clinical Therapeutics 28:2, 151-173
CrossRef3
Mone Zaidi, Harry C Blair, Baltit S Moonga, Etsuko Abe, Christopher L-H Huang. (2003) Osteoclastogenesis, Bone Resorption, and Osteoclast-Based Therapeutics. Journal of Bone and Mineral Research 18:4, 599-609
CrossRef4
Bryce Binstadt, Henry Bernstein. (2002) Current Opinion in Pediatrics 14:4, 498-507
CrossRef5
G Thomas Ray. (2002) Pneumococcal conjugate vaccine: economic issues of the introduction of a new childhood vaccine. Expert Review of Vaccines 1:1, 65-74
CrossRef6
Giebink, G. Scott, . (2001) The Prevention of Pneumococcal Disease in Children. New England Journal of Medicine 345:16, 1177-1183
Full Text7
(2001) Current Awareness. Pharmacoepidemiology and Drug Safety 10:6, 561-576
CrossRef8
J. A. Eisman. (2001) Options for Osteoporosis Treatment in the Elderly. International Bone and Mineral Society Knowledge Environment 1:1, 2001040-0
CrossRef
