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January 30, 2008

Prevention of fractures Risedronate in postmenopausal women with osteopenic

Urdinola Jaime MD

Medical Association Andes Bogotá DC Colombia Telephone 571/215 23 00

e-mail: jaimeurdinolamd@gmail.com - jurdinol @ UNIANDES. edu.co

blogger: www.urdinola.blogspot.com www.urdinolamenopausia.blogspot.com www.urdinolamenopausia2.blogspot.com

Symposium / Luncheon on Women's Health and Menopause

Association Medical Andes - Board Room - Wednesday, January 30, 2008

The World Health Organization (WHO) recommended initially included within the definition of osteoporosis, should be included in combination, the measurement of bone mineral density (BMD) and susceptibility to fracture.

As was noted that this definition was not very useful for clinical practice, WHO and the National Osteoporosis Foundation of America (NOF) agreed to define it in terms of BMD.

Osteopenia: BMD between -1 standard deviation (SD) and - 2.5 SD below the mean for young adults ("T" in bone densitometry.)

The 4 times more women develop osteoporosis than men due to estrogen deficiency during menopause.
A woman aged 80 has lost 80% of BMD, while man has lost only 25%.
The relationship of fractures of women to men is 7 / 1 of the vertebrae and 2 / 1 in the femoral head.

If we accept the 9% chance for a woman throughout her life in the U.S. develop breast cancer, that same woman will have 30% chance to develop an osteoporotic fracture.

Half of the women who reach age 70 will develop some type of osteoporotic fracture. So it is estimated that one of every 3 women will be postmenopausal osteoporotic fracture.

fractures in Colombia over 45 years old is ranked No. 5. in frequency of hospital discharges 1.
Moreover, the question of whom to treat has no single clear answer. There are two consensus that mark the current trend, the American Association of Endocrinology and the NOF 2 year 2 000, supported by the National Institutes of Health U.S. (NIH) 3 in 2 001.

In summary, the recommendation is to treat
- Menopausal women with a history of vertebral or hip fracture
- Those with a value of "T" ˂ 2.0 (or 2.5 According ˂ American Association of Clinical Endocrinologists
4) no risk factors
- Those with a value of "T" ˂ 1.5 with
risk factors - Those in the limit lower BMD with risk factors

But the decreased bone mass, defined as the range of osteopenia, osteoporosis can progress to if left untreated. Furthermore, it has already shown that about half of fragility fractures occur in women with osteopenia 5 .

With this background it is interesting to review the publication of Siris et al 6 , further analysis of 4 analysis study on the efficacy of risedronate (randomized controlled studies BMD Multinational, BMD North America, VERT Multinational and VERT North America), in reducing fractures in postmenopausal women osteopenia.

Short and concrete, interesting and positive is that risedronate reduced the risk of fractures in 73% (p = 0.023) in this population of women with decreased bone mass at the femoral neck and no prevalent vertebral fractures.

If half of fractures occur in osteopenic women, this underlines the need for a treatment to reduce this risk fracture.

The analysis of this study reports on the effect of risedronate in doses of 5 mg daily for 1.5 to 3 years compared with placebo in osteopenic women without prevalent vertebral fractures.

was also conducted a sensitivity analysis excluding patients who were osteopenic at the neck, but had a ˂ BMD 2.5 on the spine.
study included 620 women with osteopenia who received placebo (n = 309) or risedronate 5 mg (n = 311).
Risedronate reduced the risk for fragility fractures (which are composed incidental morphometric vertebral fractures and nonvertebral fractures related with osteoporosis, eg, six types of fractures including clavicle, humerus, wrist, pelvis, hip or leg, to include end-point analysis of fractures that can be confirmed radiologically) in 73% over 3 years.

The cumulative incidence of fragility fractures was 6.9% in patients receiving placebo vs. 2.2% in those treated with risedronate. The magnitude of this effect was similar in the subgroup of the sensitivity analysis.

Another fundamental contribution of this study is that despite the existing guideline recommendations for treating menopausal osteopenic (with decreased BMD), existing data are limited regarding the effectiveness of treatments for osteoporosis, in reducing fractures in these women. It must be remembered that there is an inherent difficulty in collecting such data in studies, since they are generally excluded women with values \u200b\u200bof "T" high, which may be in the range of osteopenia. Likewise, the incidence of fracture is lower compared to patients with osteoporosis.

The sensitivity study that included 293 women with BMD between - 2.5 and - 1 SD, the ratio of risk for fragility fractures was 0.22 (95% confidence interval, 0.03 - 2.02, p = 0.182 ) With a magnitude of effect similar to the analysis of the primary population. Not included in the study were patients with osteopenia simultaneously hip and spine.

benefits obtained in similar patients with alendronate and raloxifene are lower than those obtained with risedronate. But it should be noted that studies of these 2 compounds included women with prevalent vertebral fractures, what would categorize it as not as osteopenic and osteoporotic.

The benefit on fracture risk in postmenopausal osteopenic, observed with risedronate, is based in part on its action on bone microarchitecture, preserving trabecular architecture, trabecular number and thickness and separation. The effect is preserved in the long term.

But even the positive findings may be overestimated in relation to fracture risk in the general population of menopausal women, since the original studies were designed to examine the efficacy of risedronate in a population with osteoporosis should not forget that the osteopenia may be an important risk factor for fracture in the range of 10 years.

For this reason, the tratamientocon Risedronate is also indicated in these cases of osteopenia with apparent low risk for fracture.

Highlights

● Osteopenia: Bone mineral density (BMD) between -1 standard deviation (SD) and - 2.5 SD below the mean for young adults ("T" on bone densitometry)

● In general, a woman will have throughout his life, a 30% chance to present an osteoporotic fracture

● The osteopenia in women also means a risk factor for fracture

● Risedronate reduced the risk of fractures in 73% (p = 0.023) in this population women with decreased bone mass at the femoral neck and no prevalent vertebral fractures

Question

- you is routine for women with osteopenia?
- or only those with osteoporosis is manifest?



References 1 - Consensus Development Conference. Diagnosis, Prophylaxis, and Treatment of osteoporosis. Am J Med 1993, 94: 646-650.
2 - Heinemann DF. Osteoporosis. An overview of the National Osteoporosis Foundation clinical practice guide. Geriatrics. 2000, 55:31-6.
3 - NIH Consensus Development Panel on Osteoporosis Prevention, Diagnosis, and Therapy. JAMA 2001; 285: 785 - 795th
4 - Hodgson SF , Watts NB , Bilezikian JP , Clarke BL , Gray TK , Harris DW , Johnston CC Jr , Kleerekoper M , Lindsay R , Luckey MM , McClung MR , Nankin HR , Petak SM , Recker RR , Anderson RJ , Bergman DA , Bloom Garden ZT , Dickey RA , Palumbo PJ , Peters AL , Rettinger HI , Rodbard HW , Rubenstein HA ; AACE Osteoporosis Task Force . American Association of Clinical Endocrinologists medical guidelines for clinical practice for the prevention and treatment of postmenopausal osteoporosis: 2001 edition, with selected updates for 2003. Endocr Pract. 2003;9:544-64.
5 - Sanders KM, Nicholson GC, Watts JJ, Pasco JA, Henry MJ, Kotowicz MA, Seeman E. Half the burden of fragility fractures in the community occur in women without osteoporosis. When is fracture prevention cost-effective? Bone. 2006 ;38:694-700.
6 - Siris ES, Simon JA, Barton IP, McClung MR, Grauer A. Effects of risedronate on fracture Risk in Women with postmenopausal osteopenia. DOI 10.1007/s00198-007-0493-y Int osteoporosis

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