Denosumab for Prevention of Fractures in Postmenopausal Women with Osteoporosis

Cummings, Steven R.; Martín, Javier San; McClung, Michael R.; Siris, Ethel S.; Eastell, Richard; Reid, Ian R.; Delmas, Pierre D.; Zoog, Holly Brenza; Austin, Matt; Wang, Andrea; Kutı́lek, Štěpán; Adami, Silvano; Zanchetta, José R.; Libanati, Cesar; Siddhanti, Suresh; Christiansen, Claus

doi:10.1056/nejmoa0809493

Cited by 2,837 publications

(2,035 citation statements)

References 32 publications

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“…Lastly, this study represents a single cohort study. Further studies on percutaneous treatment of ABC may include multiple arms including supplemental use of oral doxycycline or primary treatment of ABC with RANK-ligand inhibitors such as denosumab [9] as well as more rigorous evaluation of interobserver measurement variations of cyst/lesion volume and cortical thickness. We found all patients had a reduction in the size of the area of lytic destruction if not complete resolution of lytic foci (in two patients).…”

Section: Resultsmentioning

confidence: 99%

Percutaneous Doxycycline Treatment of Aneurysmal Bone Cysts With Low Recurrence Rate: A Preliminary Report

Shiels

Mayerson

2013

Clinical Orthopaedics &Amp; Related Research

110

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Section: Resultsmentioning

confidence: 99%

Percutaneous Doxycycline Treatment of Aneurysmal Bone Cysts With Low Recurrence Rate: A Preliminary Report

Shiels

Mayerson

2013

Clinical Orthopaedics &Amp; Related Research

110

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“…Since fractures are less common in men, all major pharmaceutical interventions for primary prevention of fractures were exclusively tested in postmenopausal women, with more than 40,000 women included in these studies [2,5,7,8,14,24,25]. A smaller study involving men established the effectiveness of these therapies on surrogate markers, such as increased BMD and bone turnover.…”

Section: Search Strategy and Criteriamentioning

confidence: 99%

Gender Differences in Osteoporosis and Fractures

Cawthon

2011

Clinical Orthopaedics &Amp; Related Research

245

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Background Osteoporosis is generally thought of as a ''woman's disease'' because the prevalence of osteoporosis and the rate of fractures are much higher in postmenopausal women than in older men. However, the absolute number of men affected by osteoporosis and fractures is large, as at least 2.8 million men in the United States are thought to have osteoporosis. Questions/purposes The purposes of this review are to (1) highlight gender differences in osteoporosis and fracture risk, (2) describe disparities in treatment and outcomes after fractures between men and women, and (3) propose solutions to reducing disparities in treatment and prevention. Methods A literature survey was conducted using MEDLINE with a variety of search terms and using references from the author's personal collection of articles. A formal search strategy and exclusion criteria were not employed and the review is therefore selective. Where are we now? Postmenopausal women have a higher prevalence of osteoporosis and greater incidence of fracture than older men. Despite the higher fracture risk in postmenopausal women, older men tend to have worse outcomes after fracture and poorer treatment rates, although less is known about the disease course in men.Multifaceted interventions to improve the screening and treatment for osteoporosis were recently developed. Where do we need to go? Improvement in treatment rates of those at risk, regardless of gender, is an important goal in osteoporosis management. How do we get there? Further development and evaluation of cost-effective, multifaceted interventions for screening and treatment of osteoporosis and fractures are needed; such interventions will likely improve the primary prevention of fractures.

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“…(3) In FREEDOM, 7808 women aged 60 to 90 years with a BMD T-score < À2.5 at either the lumbar spine or total hip and ! À4.0 at both sites were randomly assigned to receive subcutaneous injections of denosumab (60 mg) or placebo every 6 months for 3 years.…”

Section: Study Populationmentioning

confidence: 99%

“…(3) Several risk factors for fracture are recognized, including age, BMD, body mass index (BMI), and a history of vertebral or nonvertebral fracture. The therapeutic effects of antiresorptive agents may differ across categories of risk factors.…”

Section: Introductionmentioning

confidence: 99%

Effect of denosumab treatment on the risk of fractures in subgroups of women with postmenopausal osteoporosis

McClung

Boonen

Törring

et al. 2011

Journal of Bone and Mineral Research

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Denosumab reduces the risk of new vertebral and nonvertebral fractures. Previous trials suggest that the efficacy of antiresorptives on fractures might differ by patients' characteristics, such as age, bone mineral density (BMD), and fracture history. In the FREEDOM study, 7808 women aged 60 to 90 years with osteoporosis were randomly assigned to receive subcutaneous injections of denosumab (60 mg) or placebo every 6 months for 3 years. New vertebral and nonvertebral fractures were radiologically confirmed. Subgroup analyses described in this article were prospectively planned before study unblinding to evaluate the effect of denosumab on new vertebral and nonvertebral fractures across various subgroups. Compared with placebo, denosumab decreased the risk of new vertebral fractures in the overall study population over 3 years. This effect did not significantly differ for any of the nine subgroups analyzed ( p > 0.09 for all potential interactions). Denosumab also reduced all nonvertebral fractures by 20% in the full study cohort over 3 years. This risk reduction was statistically significant in women with a baseline femoral neck BMD T-score À2.5 but not in those with a T-score > À2.5; in those with a body mass index (BMI) < 25 kg/m 2 but not ! 25 kg/m 2 ; and in those without but not with a prevalent vertebral fracture. These differential treatment effects were not explained by differences in BMD responses to denosumab. Denosumab 60 mg administered every 6 months for 3 years in women with osteoporosis reduced the risk of new vertebral fractures to a similar degree in all subgroups. The effect of denosumab on nonvertebral fracture risk differed by femoral neck BMD, BMI, and prevalent vertebral fracture at baseline. ß

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Denosumab for Prevention of Fractures in Postmenopausal Women with Osteoporosis

Abstract: Denosumab given subcutaneously twice yearly for 36 months was associated with a reduction in the risk of vertebral, nonvertebral, and hip fractures in women with osteoporosis. (ClinicalTrials.gov number, NCT00089791.)

Cited by 2,837 publications

References 32 publications

Percutaneous Doxycycline Treatment of Aneurysmal Bone Cysts With Low Recurrence Rate: A Preliminary Report

Percutaneous Doxycycline Treatment of Aneurysmal Bone Cysts With Low Recurrence Rate: A Preliminary Report

Gender Differences in Osteoporosis and Fractures

Effect of denosumab treatment on the risk of fractures in subgroups of women with postmenopausal osteoporosis

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