Effect of Alendronate on Vertebral Fracture Risk in Women With Bone Mineral Density T Scores of −1.6 to −2.5 at the Femoral Neck: The Fracture Intervention Trial

Department of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC 25717-1063, USA.
Mayo Clinic Proceedings (Impact Factor: 6.26). 04/2005; 80(3):343-9. DOI: 10.4065/80.3.343
Source: PubMed


To determine the efficacy of alendronate treatment on risk of vertebral fracture in a subgroup of women from the Fracture Intervention Trial who had bone mineral density T scores between -1.6 and -2.5 at the femoral neck and to describe how soon after initiation of therapy alendronate becomes effective and whether it is consistent in women with and without existing radiographic vertebral fracture.
From May 1992 to March 1997, postmenopausal women aged 55 to 80 years were randomized to receive alendronate at 5 mg/d for 2 years and 10 mg/d thereafter or placebo for up to 4.5 years (mean, 3.8 years) in a controlled, double-blind, multicenter study.
A total of 3737 postmenopausal women were included in the study, 1878 in the alendronate group and 1859 in the placebo group. Risk of vertebral fracture was significantly reduced by alendronate compared with placebo for clinical (relative risk [RR], 0.40; 95% confidence interval [CI], 0.19-0.76; P=.005) and radiographic (RR, 0.57; 95% CI, 0.41-0.81; P=-.002) fracture. The reductions in vertebral fracture risk were consistent in women with and without an existing radiographic vertebral fracture for clinical (RR, 0.34; 95% CI, 0.12-0.84; and RR, 0.46; 95% CI, 0.16-1.17; respectively) and radiographic (RR, 0.53; 95% CI, 0.34-0.82; and RR, 0.64; 95% CI, 0.38-1.10; respectively) fractures. In both groups, the effect of alendronate on clinical vertebral fracture was noted soon after therapy was initiated. The absolute risk of vertebral fracture was low in women without a baseline radiographic fracture.
In women with low bone mass who do not meet the bone mineral density criterion for osteoporosis, alendronate is effective in reducing the risk of vertebral fractures. The absolute benefit of this therapy in women with a T score between -1.6 and -2.5 is greater in women with an existing vertebral fracture and/or with other risk factors. The effect of alendronate occurs early.

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    • "A lot of these discussions have centered around estimates of numbers needed to treat (NNT). While the most effective antiresorptive treatment today have NNT values for prevention of one fracture around 13–15 for spine fractures similar numbers in osteopenia patients are 8–10 fold higher [4, 5]. As shown in the analysis of Quandt et al. [4] the presence of a prevalent fracture yields a NNT for subsequent fracture over the next 5 years of 26, compared to 125 in patients without fractures at entry into the study. "
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    ABSTRACT: The majority of osteoporotic fractures happen in individuals with BMD t-scores in the osteopenic range (-2,5< t-score <-1). However, widespread use of anti-osteoporotic medication in this group based on t-score alone is not advisable because: 1) the number needed to treat is much higher (NNT>100) than in patients with fractured and t-score below -2,5 (NNT 10-20); 2)while specific osteoporosis treatments have demonstrated significant reductions of the fracture risk in patients with t-score <-2, 5, the efficacy in patients in the osteopenic range is less well established. Therefore, an osteopenic t-score does not in itself constitute a treatment imperative. Generally, osteopenia has to be associated with either low energy fracture(s) or very high risk for future fracture as assessed with risk calculators like FRAX to warrant specific osteoporosis therapy. Vertebral fractures are now conveniently assessed using lateral x-rays from DXA machines. In the vast majority of cases antiresorptive treatments (mainly hormone replacement therapy and SERMS in younger and bisphosphonates or Denosumab in older women) are the treatments of choice in this group of patients,-only rarely is anabolic therapy indicated.
    Reviews in Endocrine and Metabolic Disorders 06/2011; 13(3):209-23. DOI:10.1007/s11154-011-9187-z · 4.89 Impact Factor
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    • "Fracture reduction efficacy for subgroups of women with T-scores in the osteopenic range have been reported for both raloxifene[23] and alendronate[24]. While there is disagreement about whether alendronate reduces risk of vertebral fracture in osteopenic women [24-27], we assumed that the vertebral fracture risk reduction with alendronate that was reported for women with osteoporosis[25] also applied to women with osteopenia. Neither therapy has demonstrated efficacy in preventing nonvertebral fractures in osteopenic women [23-25]. "
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    ABSTRACT: Limited data are available regarding the cost-effectiveness of preventative therapies for postmenopausal women with osteopenia. The objective of the present study was to evaluate the cost-effectiveness of raloxifene, alendronate and conservative care in this population. We developed a microsimulation model to assess the incremental cost and effectiveness of raloxifene and alendronate relative to conservative care. We assumed a societal perspective and a lifetime time horizon. We examined clinical scenarios involving postmenopausal women from 55 to 75 years of age with bone mineral density T-scores ranging from -1.0 to -2.4. Modeled health events included vertebral and nonvertebral fractures, invasive breast cancer, and venous thromboembolism (VTE). Raloxifene and alendronate were assumed to reduce the incidence of vertebral but not nonvertebral fractures; raloxifene was assumed to decrease the incidence of breast cancer and increase the incidence of VTEs. Cost-effectiveness is reported in $/QALYs gained. For women 55 to 60 years of age with a T-score of -1.8, raloxifene cost approximately $50,000/QALY gained relative to conservative care. Raloxifene was less cost-effective for women 65 and older. At all ages, alendronate was both more expensive and less effective than raloxifene. In most clinical scenarios, raloxifene conferred a greater benefit (in QALYs) from prevention of invasive breast cancer than from fracture prevention. Results were most sensitive to the population's underlying risk of fracture and breast cancer, assumed efficacy and costs of treatment, and the discount rate. For 55 and 60 year old women with osteopenia, treatment with raloxifene compares favorably to interventions accepted as cost-effective.
    BMC Women's Health 02/2007; 7(1):6. DOI:10.1186/1472-6874-7-6 · 1.50 Impact Factor
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    ABSTRACT: The aim of the study was the determination of the prevalence of asymptomatic vertebral deformities in healthy persons of the Polish population, based on morphometric X-ray absorptiometry (MXA), and comparison of the results with data from literature, obtained by other techniques. The study involved 829 persons, including 520 women and 309 men, aged 18-79 years, untreated for osteoporosis before. The Th(4) to L(4) vertebrae were examined. Lateral scans of the thoracic-lumbar spine were made by an Expert-XL densitometer. Six point digitization was used to calculate the anterior (Ha), central (Hc), and posterior (Hp) height of the Th(4)-L(4) vertebral bodies. The vertebrae were defined as having prevalent deformities when at least one ratio value (Ha/Hp, Hc/Hp, Hp/Hp up, or Hp/Hp low) fell 3 SDs below or even more than the reference mean of that ratio at any vertebral level. The analysis was performed on 9629 vertebrae, of which 167 (1.75%), evaluated as deformed and considered as fractures, were observed in 113 patients (13.63 % of the examined patients). In 81 persons (74% of the patients with fractures; 9.7% of the studied population), single fractures were demonstrated, while in 28 persons, multiple deformities prevailed. Fractures occurred in 108 women (20.7% of the examined women) and 42 men (13.5% of the examined men). The highest incidence of deformities was observed in women over 55 years of age. First-degree deformities dominated. Deformities of the Th(8) and Th(6) vertebrae were most frequently observed. 1. Using MXA, it was found that in the Polish population deformities of vertebrae are common, as was demonstrated in X-ray morphometric studies in the European Vertebral Observation Study (EVOS). 2. Densitometric morphometry, as a non-invasive technique, may become a useful tool in the diagnostics of vertebral fractures.
    Endokrynologia Polska 01/2009; 60(2):68-75. · 0.99 Impact Factor
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