Clinical trial NCT02043236: Strategies to Improve Bone Health in Men on ADT
Official title: A Phase II RCT of Strategies to Improve Bone Health in Men on ADT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate cancer
Androgen deprivation therapy
Bone health
Bone mineral density
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Society (CCS)
First posted: 2014-01-23
Enrollment: 159
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a phase II randomized controlled trial (RCT) of 2 strategies to improve bone health in men receiving androgen deprivation therapy (ADT).

Detailed description: In this RCT the investigators are comparing 2 strategies to improve bone health to usual care. Strategy 1 - Patient and physician-specific written educational material. Pilot-tested customized written educational material about bone health for men on ADT will be used for this study. A customized letter will be prepared for the patient's primary care physician, with specific advice and recommendations for the targeted strategies. Both pamphlet and letter will include a list of additional resources. Strategy 2 - patient written material and a bone health care coordinator (BHCC). The same written patient material as in strategy 1 will be used, along with a BHCC who will follow the approach of successful studies and contact the patient by phone or arrange an in-person visit at the hospital if preferred by the patient. The BHCC will also encourage the patient to pursue a bone mineral density test (BMD) with their physician and adopt bone-appropriate diet, lifestyle, and supplement intake recommendations, and will follow up with the patient at least twice over the next 3 months to facilitate behavioural changes and BMD ordering. Counselling sessions are short, typically \<15 min. The BHCC will also contact the patient's physician to help facilitate BMD testing. Time points in the study are baseline, 3-month follow up, and 6-month follow up.

Control group The control group consists of a wait-list control for 6 months, during which no specific recommendations or interventions will be made by the study team. Prostate Cancer (PC) clinicians can still provide usual care. At the end of 6 months, control group participants will be referred to the Osteoporosis Clinic at the University Health Network.

Eligibility criteria: Inclusion Criteria:

Commencing or planning to continue ADT for a least 6 months 50 years or older English fluency Life expectancy \>6 months

Exclusion Criteria:

Prior Bone Mineral Density test within 2 years Prior visit at Osteoporosis Clinic within 2 years

Primary outcomes:
measure: Patient/physician satisfaction
timeFrame: 6 months
measure: Adherence rate
timeFrame: 6 months
measure: Recruitment rate
timeFrame: 6 months
measure: Retention rate
timeFrame: 6 months
measure: BMD ordering
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: UHN
name: Shabbir Alibhai, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alibhai SMH, Breunis H, Timilshina N, Hamidi MS, Cheung AM, Tomlinson GA, Manokumar T, Samadi O, Sandoval J, Durbano S, Warde P, Jones JM. Improving bone health in men with prostate cancer receiving androgen deprivation therapy: Results of a randomized phase 2 trial. Cancer. 2018 Mar 15;124(6):1132-1140. doi: 10.1002/cncr.31171. Epub 2017 Dec 6.