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Overview Page 2

Preliminary EFFECT results: once-weekly alendronate superior to raloxifene for spine and hip BMD

Preliminary results of a year-long study of 456 women have shown that alendronate 70 mg once-weekly produces significantly greater increases in bone mineral density (BMD) of the lumbar spine and total hip than raloxifene 60 mg once-daily.1 The study results were presented at the 51st Annual Meeting of the American College of Obstetricians and Gynecologists (ACOG).

The Efficacy of Fosamax® vs. Evista® Comparison Trial (EFFECT) enrolled 456 women at 52 centers and randomized them to alendronate (n=223) or raloxifene (n=233). Patients also received calcium 500 mg and vitamin D 400 IU daily. The mean age of enrolled patients was 64 years (range: 37-89 years). All patients had osteoporosis, as defined by a T-score of 2.0 SD or greater below the mean for young adults. The mean baseline lumbar spine T-score was -2.50. A history of fracture was reported by 53%.

Bone mineral density was measured at baseline, at six months, and at 12 months. For the primary endpoint of percent change in BMD at the lumbar spine at one year, there was more than a two-fold increase in patients receiving alendronate compared with those receiving raloxifene (4.4% vs. 1.9%, respectively; p<0.001). Similarly, total hip BMD increased 2.0% for patients on alendronate and 1.0% for patients on raloxifene at one year (p<0.001). In addition, the BMD at the hip trochanter increased 3.2% in the alendronate arm and 1.8% in the raloxifene arm (p<0.001). The response rate, defined as the number of patients who maintained or increased BMD was 94% for alendronate and 75% for raloxifene. Significantly greater increases in BMD at the lumbar spine and total hip were also seen in alendronate patients at the six-month data point (p<0.001 for the spine; p<0.013 for the hip).

Risa Kagan, MD, co-medical director of FORE-Foundation for Osteoporosis Research, noted that there were no clinically apparent vertebral or hip fractures in either arm, but there were a variety of fractures of the wrist, shoulder, or toes; these data will be presented at a later date. The discontinuation rate was 11.2% in the alendronate arm and 1.3% in the raloxifene arm.

REFERENCES

  1. Kagan R, Greenspan SL, Sackarowitz J, et al. Efficacy of Fosamax vs. Evista Comparison Trial (EFFECT): Results of a randomized, multicenter study. Obstet Gynecol. 2003;101(4 Suppl).

Osteoporosis continues to be underdiagnosed -- even in patients with fractures

Despite advances in diagnostic technology, osteoporosis remains an underdiagnosed disease. In a recent retrospective cohort study of 206 patients (146 female, 60 male) with radiographic findings of vertebral compression fractures, only 38% (46% of women and 19% of men) had already been diagnosed with osteoporosis.1 Furthermore, only 32% (39% of women and 14% of men) received prescription medications for osteoporosis. Many of the patients had several risk fractures for osteoporosis, including 68% of the women and 48% of the men, who had multiple compression fractures of the vertebrae.

Women younger than 50 (adjusted odds ratio = 0.09; 95% CI = 0.01-0.71) and 90 or older (AOR = 0.27; 95% CI = 0.08- 0.98) were less likely to have been diagnosed with osteoporosis. Women with a prior hip or radial fracture (AOR= 3.65; 95% CI = 1.28-10.38) or back pain (AOR = 2.84; 95% CI = 1.38-5.85) were more likely to have been diagnosed with osteoporosis.

The authors concluded that, in the primary care setting, physicians frequently did not diagnose osteoporosis in patients with vertebral fractures, thereby missing an opportunity to prevent future fractures in patients at high risk. They called for targeted efforts to improve diagnosis as an important step in enhancing patient care. The National Osteoporosis Foundation (NOF) currently recommends that all postmenopausal women with fractures be evaluated for osteoporosis, including BMD measurements. The NOF also recommends BMD testing for all women aged 65 and for postmenopausal women younger than 65 with one or more additional risk factors.

REFERENCES
  1. Neuner JM, Zimmer JK, Hamel MB. Diagnosis and treat- ment of osteoporosis in patients with vertebral compression fractures. J Am Geriatr Soc. 2003;51(4):483-491.


NOF recommends more aggressive approach to diagnosis and treatment of low BMD

The National Osteoporosis Foundation (NOF) recently updated its Physician's Pocket Guide to Prevention and Treatment of Osteoporosis to reflect new treatment options and to encourage more extensive diagnosis and treatment of patients at risk for fractures.1 Perhaps the most significant change is the recommendation to initiate therapy in postmenopausal women with BMD T-scores below -2 in the absence of risk factors. (The previous recommendation was to treat if T-scores were below -2.5.) The updated Guide also recommends treatment if T-scores are below -1.5 if one or more risk factors are present (Table 1).


The more aggressive approach to fracture prevention is, in part, a response to the longawaited results of the National Osteoporosis Risk Assessment (NORA) trial, the largest U.S. study of osteoporosis conducted to date.2 NORA was a longitudinal observational study conducted from September 1997 to March 1999, with approximately 12 months of subsequent follow-up. The study enrolled 200,160 postmenopausal women aged 50 or older, who had not been previously diagnosed with osteoporosis. The principal outcome measures were baseline BMD T-scores obtained through peripheral bone densitometry or ultrasonography of heel, finger, or forearm, and clinical fracture rates at the 12-month follow-up.

The prevalence of osteopenia and osteoporosis among women enrolled in the study was surprisingly high. Based on the criteria of the World Health Organization, 39.6% of the enrolled patients had osteopenia (T-scores of -1 to -2.49) and 7.2% had osteoporosis (T-scores ≤-2.5). Followup data were available from 163,979 patients. Among patients with osteoporosis, there was a four-fold increase in fracture rate (95% CI; 3.59-4.53) compared with that seen in patients with normal BMDs. Among patients with osteopenia, there was a 1.8-fold increase in fracture rate (95% CI; 1.49-2.18).3

The NORA results suggest that much more can and should be done to identify and treat patients at risk for osteoporotic fractures. Almost half of the patients enrolled in this study had previously undetected low BMDs. Perhaps most alarming is the observation that patients with T-scores of -1 to -2.49, who would not have received treatment under previous NOF guidelines, had a fracture risk almost double that of patients with normal BMDs. In a commentary on NORA, Chesnut notes that "...NORA confirms what many clinicians and osteoporosis researchers have long suspected, i.e., that a significant number of postmenopausal women in pri- mary care practices have clinically significant low BMD and that such women have an increased risk of incident fracture within one year."4 Given the personal, economic, and social impact of osteoporotic fractures, a more aggressive approach to diagnosis and treatment is clearly justified.


REFERENCES
  1. Pocket Guide to Prevention and Treatment of Osteoporosis. Washington, D.C.: National Osteoporosis Foundation, 2003.
  2. Siris E, Miller P, Barrett-Connor E, et al. Design of NORA, the National Osteoporosis Risk Assessment Program. Osteoporosis Int. 1998;8(Suppl 1):S62-S69.
  3. Siris ES, Miller PD, Barrett-Connor E, et al. Identification and fracture outcomes of undiagnosed low bone mineral density in postmenopausal women: results from the National Osteoporosis Risk Assessment. JAMA. 2001;286:2815-2822.
  4. Chesnut CH. Osteoporosis, an underdiagnosed disease. JAMA. 2001; 286(22):2865-2866.



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