Alendronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women

Wells, George A.; Cranney, Ann; Peterson, Joan; Boucher, Michel; Shea, Beverley; Welch, Vivian; Coyle, Doug; Tugwell, Peter

doi:10.1002/14651858.cd001155.pub2

Cited by 329 publications

(331 citation statements)

References 91 publications

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“…Only in the relatively small subgroup of women in the highest risk tertile with high adherence to at least 5 years of bisphosphonates was observed hip fracture risk significantly less than predicted, with a treatment effect that approximated the risk reduction reported in clinical trials of bisphosphonates. (5,6,33,34) Risk stratification (based upon AUROC) and concordance (agreement between predicted fracture probability and observed fracture incidence) was similar for untreated and treated women, indicating that osteoporosis therapy does not invalidate the use of FRAX for fracture prediction. This potentially expands the clinical role of FRAX as a tool for advising patients on their need for continued treatment, and whether treatment could potentially be withdrawn.…”

Section: Discussionmentioning

confidence: 84%

Does osteoporosis therapy invalidate FRAX for fracture prediction?

Leslie

Lix

Johansson

et al. 2012

Journal of Bone and Mineral Research

115

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Ten-year fracture risk assessment with the fracture risk assessment system (FRAX) is increasingly used to guide treatment decisions. Osteoporosis pharmacotherapy reduces fracture risk, but the effect is greater than can be explained from the increase in bone mineral density (BMD). Whether this invalidates fracture predictions with FRAX is uncertain. A total of 35,764 women (age !50 years) and baseline BMD testing (1996)(1997)(1998)(1999)(2000)(2001)(2002)(2003)(2004)(2005)(2006)(2007) had FRAX probabilities retroactively calculated. A provincial pharmacy database was used to identify osteoporosis medication use. Women were categorized as untreated, current high adherence users [medication possession ratio (MPR) !0.80 in the year after BMD testing], current low adherence users (MPR <0.80), and past users. Fractures outcomes to 10 years were established form a population-based health data repository. FRAX and femoral neck BMD alone stratified major osteoporotic and hip fracture risk within untreated and each treated subgroup (all p-values <0.001) with similar area under the receiver operating characteristic curve. In untreated and each treated subgroup, a stepwise gradient in observed 10-year major osteoporotic and hip fracture incidence was found as a function of the predicted probability tertile (all p-values <0.001 for linear trend). Concordance (calibration) plots for major osteoporotic fractures and hip fractures showed good agreement between the predicted and observed 10-year fracture incidence in untreated women and each treated subgroup. Only in the highest risk tertile of women highly adherent to at least 5 years of bisphosphonate use was observed hip fracture risk significantly less than predicted, though major osteoporotic fracture risk was similar to predicted. In summary, this work suggests that the FRAX tool can be used to predict fracture probability in women currently or previously treated for osteoporosis. Although FRAX should not be used to assess the reduction in fracture risk in individuals on treatment, it may still have value for guiding the need for continued treatment or treatment withdrawal. ß

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Section: Discussionmentioning

confidence: 84%

Does osteoporosis therapy invalidate FRAX for fracture prediction?

Leslie

Lix

Johansson

et al. 2012

Journal of Bone and Mineral Research

115

View full text Add to dashboard Cite

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“…(3) The projected cost of hip fracture for the year 2025 is approximately $18 billion in the United States (4) and £1.5 billion in the United Kingdom. (2) Data from randomized controlled trials (RCTs) have showed that bisphosphonate treatment is highly effective for the secondary prevention of osteoporotic fracture, (5) including among hip fracture patients. (6) This is reflected in many clinical guidelines from around the world that recommend the use of bisphosphonate for patients having sustained a minimal trauma fracture.…”

Section: Introductionmentioning

confidence: 99%

Anti-Osteoporosis Medication Prescriptions and Incidence of Subsequent Fracture Among Primary Hip Fracture Patients in England and Wales: An Interrupted Time-Series Analysis

Hawley

Leal

Delmestri

et al. 2016

Journal of Bone and Mineral Research

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In January 2005, the National Institute for Health and Care Excellence (NICE) in England and Wales provided new guidance on the use of antiosteoporosis therapies for the secondary prevention of osteoporotic fractures. This was shortly followed in the same year by market authorization of a generic form of alendronic acid within the UK. We here set out to estimate the actual practice impact of these events among hip fracture patients in terms of antiosteoporosis medication prescribing and subsequent fracture incidence using primary care data (Clinical Practice Research Datalink) from 1999 to 2013. Changes in level and trend of prescribing and subsequent fracture following publication of NICE guidance and availability of generic alendronic acid were estimated using an interrupted time series analysis. Both events were considered in combination within a 1-year "intervention period." We identified 10,873 primary hip fracture patients between April 1999 and Sept 2012. Taking into account prior trend, the intervention period was associated with an immediate absolute increase of 14.9% (95% CI, 10.9 to 18.9) for incident antiosteoporosis prescriptions and a significant and clinically important reduction in subsequent major and subsequent hip fracture: -0.19% (95% CI, -0.28 to -0.09) and -0.17% (95% CI, -0.26 to -0.09) per 6 months, respectively. This equated to an approximate 14% (major) and 22% (hip) reduction at 3 years postintervention relative to expected values based solely on preintervention level and trend. We conclude that among hip fracture patients, publication of NICE guidance and availability of generic alendronic acid was temporally associated with increased prescribing and a significant decline in subsequent fractures.

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“…1,2 Furthermore, a recent systematic review analyzing 11 randomized controlled trials (RCTs) representing 12,068 women confirmed that ALN treatment resulted in both clinically important and statistically significant reductions in vertebral, non-vertebral, hip, and wrist fractures for secondary prevention (goldlevel evidence). 3 An analysis of the FIT demonstrated that ALN treatment was effective for reducing the risk of symptomatic osteoporotic fractures including hip, clinical spine, and wrist fractures across a spectrum of ages (55 -85 years), although the absolute risk reduction with ALN treatment increased with age because of the age-related increase in the fracture risk in the placebo group. 4 RCTs in postmenopausal Japanese women with osteoporosis (mean ages: 63-72 years) also revealed that short-term (1-3 years) ALN treatment suppressed bone turnover, increased the bone mineral density (BMD), and reduced the incidence of vertebral fractures.…”

Section: Introductionmentioning

confidence: 99%

Three-year outcome of alendronate treatment in older Japanese women with osteoporosis

et al. 2012

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The effects of alendronate (ALN) treatment on the bone mineral density (BMD), bone turnover markers, and fracture incidence remain to be established in older Japanese patients. The aim of the present study was to compare the outcome of ALN treatment for 3 years among postmenopausal osteoporotic Japanese women <80 years of age and those ≥80 years of age. One hundred ninety-eight postmenopausal osteoporotic women who had been treated with ALN for more than 3 years were analyzed. The 3-year outcome was compared between women <80 years of age (control group, n=167) and those ≥80 years of age (older group, n=31). During the 3-year treatment period, the urinary cross-linked N-terminal telopeptides of the type I collagen and serum alkaline phosphatase levels significantly decreased and the lumbar spine BMD significantly increased, compared with the baseline values, in manners that were similar in the control and older groups. However, the incidence of non-vertebral fractures, but not of vertebral fractures, was significantly higher in the older group than in the control group (16.1% vs 3.0%). These results suggested that the incidence of non-vertebral fractures was significantly higher among postmenopausal osteoporotic Japanese women ≥80 years of age who were treated with ALN than among those <80 years of age despite the similar effect of ALN treatment on surrogate markers.

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Alendronate for the primary and secondary prevention of osteoporotic fractures in postmenopausal women

Cited by 329 publications

References 91 publications

Does osteoporosis therapy invalidate FRAX for fracture prediction?

Does osteoporosis therapy invalidate FRAX for fracture prediction?

Anti-Osteoporosis Medication Prescriptions and Incidence of Subsequent Fracture Among Primary Hip Fracture Patients in England and Wales: An Interrupted Time-Series Analysis

Three-year outcome of alendronate treatment in older Japanese women with osteoporosis

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