This trial is active, not recruiting.

Condition locally advanced malignant neoplasm
Treatment bone health educational materials
Sponsor University Health Network, Toronto
Collaborator Canadian Association of Radiation Oncology
Start date September 2013
End date September 2016
Trial size 200 participants
Trial identifier NCT01973673, 13-6050


Prostate cancer patients receiving hormone treatment (androgen deprivation therapy, or ADT) are at increased risk of developing bone loss and osteoporosis as side effects. To prevent this, guidelines recommend participation in healthy bone behaviours including weight-bearing exercise and adequate calcium/vitamin D intake. However, prior studies have shown that patients are not regularly screened or counselled regarding healthy bone behaviours while receiving ADT. Maintaining bone health in prostate cancer patients is important because men on ADT are at increased risk of fractures. In this study, the investigators will examine whether an intervention designed to improve healthy bone behaviours among prostate cancer patients on ADT can be implemented. The intervention consists of a written "healthy bones prescription", brief verbal counseling, and printed educational materials for participants. Investigators hope to obtain an initial estimate of whether the intervention works. They also hope to show that this simple intervention can be implemented in a real, working cancer clinic.

The investigators hypothesize that an intervention to improve bone health in prostate cancer patients receiving ADT (healthy bones prescription, verbal counseling, and printed educational materials) is effective, implementable, and accepted by clinicians and patients.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
(Active Comparator)
Bone health written educational materials, Bone health prescription,verbal counselling
bone health educational materials
(No Intervention)
Usual clinical care to be provided by oncologists.

Primary Outcomes

Proportion of eligible and consented patients who complete study follow-up, as a measure of study feasibility
time frame: 6 months
Change in patient-reported daily calcium intake, as a measure of intervention efficacy
time frame: 3 months
Change in patient-reported daily vitamin D intake, as a measure of intervention efficacy
time frame: 3 months
Change in patient-reported weekly exercise duration, as a measure of intervention efficacy
time frame: 3 months

Secondary Outcomes

Proportion of eligible patients approached for enrollment who consent for entry into the study
time frame: 6 months
Time to achieve target patient accrual
time frame: unknown
Proportion of patients whose calcium, vitamin D intake, and exercise may be assessed from properly completed questionnaires
time frame: 6 months
Patient and clinician satisfaction with clinical study on a ten-point scale
time frame: 6 months
Change in patient knowledge and health benefits regarding osteoporosis, as determined with Facts on Osteoporosis Quiz - Revised, Men's Osteoporosis Knowledge Questionnaire, and Osteoporosis Health Belief Scale
time frame: 3 months
Proportion of enrolled patients having bone mineral density (BMD) tests performed within 6 months of ADT initiation
time frame: 6 months

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: Prostate cancer patients receiving ADT at study entry (for a maximum of 12 months prior to study entry or planning to receive ADT within 3 weeks of study entry), for an expected duration of >6 months; Eastern Cooperative Oncology Group (ECOG) performance status <3 Exclusion Criteria: Unable to exercise (e.g. major physical disability, severe osteoarthritis, or other severe comorbidity); severe cardiac disease (congestive heart failure with New York Heart Association (NYHA) class >2, angioplasty/coronary artery bypass surgery within 3 months of study entry); patients with bone endocrinopathy (parathyroid disorders, osteomalacia); stage IV-V chronic kidney disease (estimated glomerular filtration rate [eGFR] <30 mL/min/1.75 m2; prior serum creatinine not required for entry into study); allergy to components of calcium & vitamin D tablets.

Additional Information

Official title Healthy Bones Study: An Intervention to Improve Healthy Bone Behaviours in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT)
Principal investigator Shabbir Alibhai, MD
Description The study has a before-and-after design, to allow comparison of the intervention before its implementation and after its implementation. This design permits a reliable assessment of baseline characteristics prior to implementation of intervention and over time, particularly in situations where randomization is not feasible (e.g. due to contamination of treating physicians). The point at which the intervention will start to be delivered for new study participants is when 150 patients are accrued to the Before arm. 1. Before/control arm (Before arm) Usual care by Princess Margaret Cancer Centre (PM) oncologist. 2. After/intervention arm (After arm) Provision of a healthy bones prescription, verbal counselling, and written educational materials regarding healthy bone behaviours by PM oncologist or delegate (e.g. clinical fellow), in addition to usual care by oncologist. The intervention may be delivered again at a subsequent follow-up at the request of the patient and/or at the discretion of the oncologist.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.