This trial is active, not recruiting.

Condition prostate cancer
Treatments healthy bones pamphlet, bone health care coordinator, letter to gp
Phase phase 2
Sponsor University Health Network, Toronto
Collaborator Canadian Cancer Society Research Institute (CCSRI)
Start date November 2013
End date December 2016
Trial size 100 participants
Trial identifier NCT02043236, 13-6823


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
(Active Comparator)
Strategy 1: Written educational material to patient and GP
healthy bones pamphlet Building strong bones
written educational material
letter to gp
The letter to the General Practitioner contains information about the study, recommendations for bone health, guidelines of Osteoporosis Canada, and the identical educational material that the participant received.
(Active Comparator)
Strategy 2: Written educational material to patient and counseling from a Bone Health Care Coordinator
healthy bones pamphlet Building strong bones
written educational material
bone health care coordinator BHCC
The Bone Health Care Coordinator reviews educational materials with participant and facilitates ordering BMD.
(No Intervention)
Control group gets usual care from their oncologist.

Primary Outcomes

Patient/physician satisfaction
time frame: 6 months
Adherence rate
time frame: 6 months
Recruitment rate
time frame: 6 months
Retention rate
time frame: 6 months
BMD ordering
time frame: 6 months

Eligibility Criteria

Male participants at least 50 years old.

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

Additional Information

Official title A Phase II RCT of Strategies to Improve Bone Health in Men on ADT
Principal investigator Shabbir Alibhai, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.