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Toremifene decreases vertebral fractures in men younger than 80 years receiving androgen deprivation therapy for prostate cancer.

ABSTRACT: Androgen deprivation therapy is associated with an increased fracture risk. In a recent phase III trial toremifene significantly decreased vertebral fractures in men on androgen deprivation therapy. Similar to other selective estrogen receptor modulators, toremifene was associated with an increase in venous thromboembolic events with the greatest risk in men 80 years old or older. In this post hoc analysis we evaluated the efficacy and safety of toremifene in men younger than 80 years.This analysis included 847 men younger than 80 years, of whom 430 received toremifene 80 mg by mouth daily and 417 received placebo for up to 24 months. The primary end point was new vertebral fractures. Secondary end points included fragility fractures, bone mineral density and safety.Compared with placebo, toremifene decreased the relative risk of new vertebral fractures by 79.5% (95% CI 29.8-94.0, p <0.005). The new vertebral fracture incidence was 1.0% for toremifene and 4.8% for placebo (absolute risk reduction 3.8%). Compared with placebo, toremifene significantly decreased the incidence of nontraumatic fracture or greater than 7% bone loss by 24 months (p <0.0001). Toremifene also significantly increased bone mineral density at all measured sites (all comparisons p <0.001). The incidence of venous thromboembolic events was similar in the toremifene and placebo groups (2.1% and 1.0%, respectively, p = 0.26). The rates of other adverse events were also similar between the groups.Toremifene significantly decreased new vertebral fractures in men younger than 80 years receiving androgen deprivation therapy for prostate cancer. The risk of venous thromboembolic events was lower than in the overall study population, suggesting an improved risk-benefit profile in younger men.

SUBMITTER: Smith MR

PROVIDER: S-EPMC3671875 | biostudies-literature | 2011 Dec

REPOSITORIES: biostudies-literature

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Toremifene decreases vertebral fractures in men younger than 80 years receiving androgen deprivation therapy for prostate cancer.

Smith Matthew R MR Malkowicz S Bruce SB Brawer Michael K MK Hancock Michael L ML Morton Ronald A RA Steiner Mitchell S MS

The Journal of urology 20111019 6

<h4>Purpose</h4>Androgen deprivation therapy is associated with an increased fracture risk. In a recent phase III trial toremifene significantly decreased vertebral fractures in men on androgen deprivation therapy. Similar to other selective estrogen receptor modulators, toremifene was associated with an increase in venous thromboembolic events with the greatest risk in men 80 years old or older. In this post hoc analysis we evaluated the efficacy and safety of toremifene in men younger than 80 ...[more]

PMID: 22014807

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Project description:BackgroundAndrogen deprivation therapy (ADT) is the mainstay therapy for men with prostate cancer. However, there are musculoskeletal side effects from ADT that increase the risk for osteoporosis and fracture, and can compromise the quality of life of these individuals. The objectives of this study are to determine the efficacy of a home-based walking exercise program in promoting bone health, physical function and quality of life in men with prostate cancer receiving ADT.Methods/designA 12-month prospective, single-blinded, randomized controlled trial will be conducted to compare the Exercise Group with the Control Group. Sixty men with prostate cancer who will be starting ADT will be recruited and randomly assigned to one of the two groups: the Exercise Group will receive instructions in setting up an individualized 12-month home-based walking exercise program, while the Control Group will receive standard medical advice from the attending physician. A number of outcome measures will be used to assess bone health, physical function, and health-related quality of life. At baseline and 12 months, bone health will be assessed using dual-energy X-ray absorptiometry. At baseline and every 3 months up to 12 months, physical function will be evaluated using the Functional Assessment of Chronic Illness Therapy - Fatigue Scale, Activities-specific Balance Confidence Scale, Short Physical Performance Battery, and Six-Minute Walk Test; and health-related quality of life will be assessed using the Functional Assessment of Cancer Therapy Prostate Module and the Medical Outcomes Study 12-item Short Form Health Survey Version 2. A mixed multiple analysis of variance will be used to analyze the data.DiscussionMusculoskeletal health management remains a challenge in men with prostate cancer receiving ADT. This study addresses this issue by designing a simple and accessible home-based walking exercise program that will potentially have significant impact on reducing the risk of fracture, promoting physical function, and ultimately improving the health-related quality of life in men with prostate cancer receiving ADT.Trial registrationClinicalTrials.gov: NCT00834392.

Project description:ImportanceBone health screening is recommended for patients with prostate cancer who are initiating treatment with androgen deprivation therapy (ADT); however, bone mineral density screening rates in the US and their association with fracture prevention are unknown.ObjectiveTo assess dual-energy x-ray absorptiometry (DXA) screening rates and their association with fracture rates among older men with prostate cancer initiating treatment with androgen deprivation therapy.Design, setting, and participantsThis retrospective nationwide population-based cohort study used data from the Surveillance, Epidemiology, and End Results database and the Texas Cancer Registry linked with Medicare claims. Participants comprised 54 953 men 66 years or older with prostate cancer diagnosed between January 2005 and December 2015 who initiated treatment with ADT. Data were censored at last enrollment in Medicare and analyzed from January 1 to September 30, 2021.ExposuresDual-energy x-ray absorptiometry screening within 12 months before and 6 months after the first ADT claim.Main outcomes and measuresFrequencies of DXA screening and fracture (any fracture and major osteoporotic fracture) and overall survival were calculated. The association between DXA screening and fracture was evaluated using a multivariable Cox proportional hazards model with propensity score adjustment.ResultsAmong 54 953 men (median age, 74 years; range, 66-99 years) with prostate cancer, 4689 (8.5%) were Hispanic, 6075 (11.1%) were non-Hispanic Black, 41 453 (75.4%) were non-Hispanic White, and 2736 (5.0%) were of other races and/or ethnicities (including 121 [0.2%] who were American Indian or Alaska Native; 1347 [2.5%] who were Asian, Hawaiian, or Pacific Islander; and 1268 [2.3%] who were of unknown race/ethnicity). Only 4362 men (7.9%) received DXA screening. The DXA screening rate increased from 6.8% in 2005 to 8.4% in 2015. Lower screening rates were associated with being single (odds ratio [OR], 0.89; 95% CI, 0.81-0.97; P = .01) and non-Hispanic Black (OR, 0.80; 95% CI, 0.70-0.91; P < .001), living in small urban areas (OR, 0.77; 95% CI, 0.66-0.90; P = .001) and areas with lower educational levels (OR, 0.75; 95% CI, 0.67-0.83; P < .001), and receiving nonsteroidal androgens (OR, 0.57; 95% CI, 0.39-0.84; P = .004). Overall, 9365 patients (17.5%) developed fractures after initial receipt of ADT. The median time to first fracture was 31 months (IQR, 15-56 months). In the multivariable model with propensity score adjustment, DXA screening was not associated with fracture risk at any site (hazard ratio [HR], 0.96; 95% CI, 0.89-1.04; P = .32) among men without previous fractures before receipt of ADT. However, previous DXA screening was associated with a decreased risk of major fractures (HR, 0.91; 95% CI, 0.83-1.00; P = .05) after propensity score adjustment.Conclusions and relevanceIn this study, low DXA screening rates were observed among older men with localized or regional prostate cancer after initiation of treatment with ADT. Despite low rates of screening, evaluation of bone mineral density with a DXA scan was associated with lower risk of major fractures. These findings suggest that DXA screening is important for the prevention of major fractures among older men with prostate cancer and that implementation strategies are needed to adopt bone health screening guidelines in clinical practice.

Dataset Information

Toremifene decreases vertebral fractures in men younger than 80 years receiving androgen deprivation therapy for prostate cancer.

Publications

Toremifene decreases vertebral fractures in men younger than 80 years receiving androgen deprivation therapy for prostate cancer.

Similar Datasets

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