Improving bone health in men with prostate cancer on ADT: results of a randomized phase II trial.

Authors

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Shabbir M.H. Alibhai

University Health Network, Toronto, ON, Canada

Shabbir M.H. Alibhai , Henriette Breunis , Narhari Timilshina , Maryam S. Hamidi , George A. Tomlinson , Tharsika Manokumar , Osai Samadi , Joanna Sandoval , Sara Durbano , Angela Cheung , Padraig Richard Warde , Jennifer M. Jones

Organizations

University Health Network, Toronto, ON, Canada, Universtiy Health Network, Toronto, ON, Canada, Princess Margaret Cancer Centre, Toronto, ON, Canada, Ontario Cancer Institute, Princess Margaret Cancer Centre, Toronto, ON, Canada

Research Funding

Other

Background: Androgen deprivation therapy (ADT) is widely used to treat men with PC but is associated with accelerated bone loss and fragility fractures. Although guidelines have recommended several strategies to optimize bone health care for these men, multiple studies have shown important gaps in the quality of bone health care and there are no proven interventions to address these gaps. We conducted a phase II randomized controlled trial (RCT) of two educational interventions to see if either could improve bone health care. Methods: Men with PC starting or continuing on ADT for at least 6 months were randomized 1:1:1 to either (a) a customized bone health pamphlet for the patient and a one-page summary of bone health recommendations for their family physician (BHP+FP); (b) a BHP for the patient and support from a bone health coordinator (BHP+BHC); or (c) usual care (UC). The primary outcome was receipt of a bone mineral density (BMD) test within 6 months. Secondary outcomes included guideline-appropriate use of calcium and vitamin D, lifestyle changes, and bisphosphonate prescriptions for men at high risk of fracture. Analyses used chi-square and logistic regression. The trial is registered at clinicaltrials.gov (NCT02043236). Results: 115 men were recruited (40 men in the BHP+FP arm, 37 men in the BHP+BHC arm, and 38 men in the UC arm). Baseline characteristics were well balanced across groups. The BHP+BHC strategy (78% versus 36%, odds ratio (OR 6.19, 95% confidence interval (CI) 2.19-17.5)) but not the BHP+FP strategy (58%, OR 2.39, 95% CI 0.95-6.04) was associated with an increased odds of BMD ordering compared to UC. Both strategies were associated with numerically higher rates of calcium and vitamin D use but neither intervention was statistically significant (p > 0.20). Too few men were smoking or consuming excess alcohol to allow meaningful between-group comparisons. The BHP+BHC strategy was associated with a greater rate of exercise uptake (p = 0.028) than UC. None of the 5 men at high fracture risk received a bisphosphonate. Conclusions: BHP+BHC is associated with a greater rate of BMD ordering and exercise uptake than UC in men on ADT, but other aspects of bone health do not appear to be improved by either intervention. Clinical trial information: NCT02043236

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Abstract Details

Meeting

2016 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Patient and Survivor Care

Track

Patient and Survivor Care

Sub Track

Survivorship

Clinical Trial Registration Number

NCT02043236

Citation

J Clin Oncol 34, 2016 (suppl; abstr 10099)

DOI

10.1200/JCO.2016.34.15_suppl.10099

Abstract #

10099

Poster Bd #

87

Abstract Disclosures