COVID-19 studies are our top priority.

For new and updated trial submissions, we are processing trials as quickly as possible and appreciate your patience. We recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Type of registration
Prospectively registered

Titles & IDs
Public title
Analysing compliance with Calcium and Vitamin D supplementations in patients receiving bone resorptive agents.
Scientific title
Analysing compliance with Calcium and Vitamin D supplementations in Cancer patients receiving bone resorptive agents.
Secondary ID [1] 302377 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cancer 319157 0
Multiple Myeloma 319158 0
prostate cancer 319159 0
bone metastasis 319160 0
Breast Cancer 319679 0
Other cancers with bone metastasis 319680 0
Condition category
Condition code
Cancer 317124 317124 0 0
Cancer 317606 317606 0 0
Cancer 317607 317607 0 0
Cancer 317608 317608 0 0
Cancer 317609 317609 0 0
Other cancer types

Study type
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
An in-house quality audit was conducted at Icon Cancer Centre South Brisbane and Chermside sites in June 2018 which involved a survey that was performed with patients prescribed Denosumab for metastatic breast and prostate cancer which highlighted non-adherence to calcium and vitamin D supplementation. Of the 35 patients surveyed, 60% were compliant with their prescribed therapy. As the use of both calcium and vitamin D supplements are an integral part of patient treatment pathways, further research is needed to identify true rates of compliance by analysing a larger patient group throughout more treatment sites in order to identify areas for improvement and barriers to patient compliance. The study will be expanded from the original audit scope to include patients receiving both RANK-L inhibitors and bisphosphonates for cancer related bone metastasis and also multiple myeloma. Data collection will be carried out over 12 months or until target patient number reached. Patients to complete ONE survey only. Patients will complete e-survey either face-to-face or via email link at home after completing e-consent. Patient's information pertaining to blood results will be collected from most recent blood results (via electronic sourcing in TotalCar), and also from bloods collected at the beginning of their treatment (day 1 of starting bone-resorptive therapy)
Intervention code [1] 318659 0
Not applicable
Comparator / control treatment
not applicable
Control group

Primary outcome [1] 325208 0
- To identify rates of compliance to prescribed calcium and vitamin D supplements. This will be ascertained by completion of survey to be carried out by patients.

Survey was developed using prescriber-requested questions and the compliance assessment draws from questions included in the Morisky Medication Adherence Scale, a validated method for assessing compliance. In short, the survey is a hybrid of an investigator-written survey and an adaptation of a validated survey (Morisky)
Timepoint [1] 325208 0
Cumulative data will be assessed after all the participants have completed questionnaires and additional data has been completed
Primary outcome [2] 326785 0
To identify barriers to compliance in order to improve on patient care -This will be ascertained by survey responses by patients.
Timepoint [2] 326785 0
Cumulative data will be assessed after all the participants have completed questionnaires and additional data has been completed
Secondary outcome [1] 387180 0
not applicable.
Timepoint [1] 387180 0
not applicable

Key inclusion criteria
Patients over the age of 18 treated at Icon Cancer Centre sites where Denosumab, Pamidronate or Zoledronic acid has been prescribed between 01/01/2021 and 01/01/2022 or until goal participant numbers have been reached.

Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Patients with hyperglycemia of malignancy;
Patients with history of osteoporosis.
Patients participating in other clinical trials

Study design
Defined population
Statistical methods / analysis
As this study is of descriptive nature, analyses of assessments and treatment patterns will be reported using descriptive statistics. Summary statistics and percentages or proportions of patients with different results and predictors will be presented. Analyses will initially be conducted internally and may be pooled based on similarity of the data.

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 17609 0
Icon Cancer Care South Brisbane - South Brisbane
Recruitment hospital [2] 17610 0
Icon Cancer Care Wesley - Auchenflower
Recruitment hospital [3] 17611 0
Icon Cancer Care Southport - Southport
Recruitment hospital [4] 17612 0
Icon Cancer Care Chermside - Chermside
Recruitment postcode(s) [1] 31354 0
4101 - South Brisbane
Recruitment postcode(s) [2] 31355 0
4066 - Auchenflower
Recruitment postcode(s) [3] 31356 0
4215 - Southport
Recruitment postcode(s) [4] 31357 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 306806 0
Name [1] 306806 0
Icon Cancer Centre
Address [1] 306806 0
Level 1 / 22 Cordellia street, South Brisbane, QLD 4101.

Country [1] 306806 0
Primary sponsor type
Icon Cancer Centre
Level 1 / 22 Cordellia street, South Brisbane, QLD 4101
Secondary sponsor category [1] 307358 0
Name [1] 307358 0
Address [1] 307358 0
Country [1] 307358 0

Ethics approval
Ethics application status
Ethics committee name [1] 306961 0
The Bellberry Human Research Ethics Committee
Ethics committee address [1] 306961 0
123 Glen Osmond Road, Eastwood, South Australia 5063
Ethics committee country [1] 306961 0
Date submitted for ethics approval [1] 306961 0
Approval date [1] 306961 0
Ethics approval number [1] 306961 0

Brief summary
This observational study will examine rates of compliance with calcium and vitamin D doses prescribed to cancer patients who may benefit from taking these supplements due to the type of cancer treatment drugs they have been given.

Who is it for?
You may be eligible for this study if you are 18 or older, you are receiving cancer treatment(s) including Denosumab, Pamidronate or Zoledronic acid and you are attending one of the Icon Cancer Centres in Queensland for treatment.

Study details
All enrolled participants will be asked to complete a survey that includes questions about their current cancer treatment, and whether they have been prescribed calcium and vitamin D in addition to their cancer treatment. It is expected that the survey will take approximately 15 minutes to complete, and participants will be asked to complete this during a scheduled clinic visit, therefore additional study visits are not required.

It is hoped this research will determine the current rate of calcium and vitamin D dose compliance in patients whose cancer treatment may have a negative impact on their bone health. It is hoped this study will also identify barriers that may make it difficult for patients to maintain their calcium and vitamin D doses and will then be able to make adjustments to address these barriers.

Trial website
Not applicable
Trial related presentations / publications
Public notes

Principal investigator
Name 105598 0
A/Prof Jermaine Coward
Address 105598 0
Icon Cancer Centre South Brisbane - 293 Vulture St, South Brisbane QLD 4101
Country 105598 0
Phone 105598 0
Fax 105598 0
07 3737 4701
Email 105598 0
Contact person for public queries
Name 105599 0
Mrs Ashleigh Smith
Address 105599 0
Icon Cancer Centre Chermside - Chermside Medical Complex, 1/956 Gympie Road, Chermside QLD 4032
Country 105599 0
Phone 105599 0
+61 7 3737 4500
Fax 105599 0
07 3737 4801
Email 105599 0
Contact person for scientific queries
Name 105600 0
Ms Ashleigh Smith
Address 105600 0
Icon Cancer Centre Chermside - Chermside Medical Complex, 1/956 Gympie Road, Chermside QLD 4032
Country 105600 0
Phone 105600 0
+61 7 3737 4500
Fax 105600 0
07 3737 4801
Email 105600 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results