Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001208897
Ethics application status
Approved
Date submitted
11/05/2021
Date registered
9/09/2021
Date last updated
9/09/2021
Date data sharing statement initially provided
9/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparative Persistence With Prolia and Weekly Alendronate in 5 Asia-Pacific countries: a Prospective Observational Study.
Scientific title
Comparative Persistence With Biannual Prolia and Weekly Alendronate in post-menopausal women with osteoporosis living in one of 5 Asia-Pacific countries: a Prospective Observational Study.
Secondary ID [1] 302113 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoporosis 318740 0
Condition category
Condition code
Musculoskeletal 316755 316755 0 0
Osteoporosis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients are postmenopausal women receiving treatment for osteoporosis in accordance
with the approved local Prescribing Information in 5 Asia-Pacific countries where Prolia
and alendronate are commercially available (Australia, Taiwan, Korea, Hong Kong,
Singapore, and Thailand).

Patients will be enrolled in 1 of 2 treatment groups based on their current prescription:
• Prolia 60 mg 6 monthly subcutaneous injections
• alendronate 70 mg once weekly orally (branded, branded combination therapy, or generic)

Enrollment period is expected to take approximately 24 months. Each patient will be
followed for approximately 24 months from the time of enrollment to the end of study. The total duration of the study is expected to be about 4 years.
Intervention code [1] 318414 0
Not applicable
Comparator / control treatment
Prolia (denosumab)
Control group
Active

Outcomes
Primary outcome [1] 324881 0
To compare persistence with Prolia to persistence with weekly alendronate in postmenopausal women with osteoporosis at 12 months.
For Prolia, persistence at 12 months is defined as the patient receiving her second
injection of Prolia within 8 months of the first injection.
For alendronate, persistence at 12 months is defined as remaining on therapy with no
gap > 60 days during the 12-month period between the index date and the last
dispensation date of alendronate plus the days’ supply based on the quantity of pills for
the last dispensation.
Timepoint [1] 324881 0
12 Months post enrolment
Secondary outcome [1] 386088 0
To compare persistence with Prolia to persistence with weekly alendronate in postmenopausal women with osteoporosis at 24 months.
For Prolia, persistence at 24 months is defined as the patient receiving her second, third,
and fourth injections of Prolia within 8 months of the previous injection.
For alendronate, persistence at 24 months is defined as remaining on therapy with no
gap > 60 days during the 24-month period between the index date and the last
dispensation date of alendronate plus the days’ supply based on the quantity of pills for
the last dispensation.
Timepoint [1] 386088 0
24 Months post enrollment
Secondary outcome [2] 386089 0
Compliance to Prolia and weekly alendronate at 12 and 24 months
Compliance at 12 and 24 months is defined as the total days on therapy divided by the
length of follow-up (MPR). Patients will be considered compliant if the MPR is more than or equal to 0.80.
Assessment of alendronate persistence will be based on the number of filled prescriptions. Patients will be asked to retain and provide all filled prescriptions (including empty bottles/packs) upon return to investigator‘s office. This may be supplemented by pharmacy records.
Timepoint [2] 386089 0
12 and 24 Months post enrolment
Secondary outcome [3] 386090 0
To assess the incidence rate of spontaneously reported adverse events overall and by treatment.
- patient incidence of spontaneously reported adverse events by self reporting to the clinicians at the 12 month and 24 month visit.
Timepoint [3] 386090 0
Assessed at the 12 month and 24 month post enrollment visit

Eligibility
Key inclusion criteria
Postmenopausal women eligible for treatment for osteoporosis in accordance with the approved local Prescribing Information
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient has any kind of disorder that, in the opinion of the investigator, may
compromise the ability of the patient to give written informed consent.
Patient has contraindication for treatment with Prolia and alendronate according
to the approved local Prescribing Information.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The study has an 80% power (with type 1 error rate of 0.05) to detect a significant
difference in persistence between treatment arms at 12 months. Based on analyses of
persistence with these therapies in real-world data and prospective studies (randomized
and observational), 12-month persistence with Prolia and alendronate is estimated to be
70% and 45%, respectively; these estimates are based upon observational and
real-world studies, rather than randomized studies.
Fischer’s exact t-test indicates that 69 patients per country per treatment group are
required to detect difference in persistence in each country at 12 months. To account for
an estimated withdrawal rate of 10%, approximately 77 patients per country per
treatment group will be enrolled.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
10/02/2020
Date of last participant enrolment
Anticipated
9/09/2021
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
770
Accrual to date
446
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
Recruitment hospital [1] 17314 0
Westmead Hospital - Westmead
Recruitment hospital [2] 17315 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 17316 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 17317 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [5] 17318 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [6] 17319 0
St Vincents & Mercy Private Hospital - Mercy campus - East Melbourne
Recruitment hospital [7] 17320 0
Novatrials - Kotara
Recruitment hospital [8] 17321 0
Keogh Institute for Medical Research - Nedlands
Recruitment postcode(s) [1] 31040 0
2145 - Westmead
Recruitment postcode(s) [2] 31041 0
3050 - Parkville
Recruitment postcode(s) [3] 31042 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 31043 0
6150 - Murdoch
Recruitment postcode(s) [5] 31044 0
2065 - St Leonards
Recruitment postcode(s) [6] 31045 0
3002 - East Melbourne
Recruitment postcode(s) [7] 31046 0
2289 - Kotara
Recruitment postcode(s) [8] 31047 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 22872 0
Korea, Republic Of
State/province [1] 22872 0
Country [2] 22873 0
Singapore
State/province [2] 22873 0
Country [3] 22874 0
Taiwan, Province Of China
State/province [3] 22874 0
Country [4] 22875 0
Hong Kong
State/province [4] 22875 0

Funding & Sponsors
Funding source category [1] 308577 0
Commercial sector/Industry
Name [1] 308577 0
Amgen Inc.
Country [1] 308577 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Amgen Inc.
Address
One Amgen Center Drive
Thousand Oaks, CA 91320-1799 USA
Country
United States of America
Secondary sponsor category [1] 309435 0
None
Name [1] 309435 0
Address [1] 309435 0
Country [1] 309435 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306733 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 306733 0
Office for Research
The Royal Melbourne Hospital
Level 2 South West
300 Grattan Street
Parkville VIC 3050
Australia
Ethics committee country [1] 306733 0
Australia
Date submitted for ethics approval [1] 306733 0
Approval date [1] 306733 0
25/10/2019
Ethics approval number [1] 306733 0

Summary
Brief summary
The primary objective of this study is to compare persistence with Prolia to persistence with weekly alendronate in postmenopausal women with osteoporosis at 12 months.
The clinical hypothesis is that denosumab 60 mg 6-monthly subcutaneous (Prolia) treatment will result in a higher proportion of patients being persistent at 12 months of treatment compared with 70 mg once weekly alendronate treatment in the 5 Asian-Pacific countries included in this study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104834 0
Dr Christopher Yates
Address 104834 0
The Royal Melbourne Hospital – City Campus | 4 West, Room 424, Diabetes Research Unit
Grattan Street, Parkville Victoria 3050
Country 104834 0
Australia
Phone 104834 0
+614037642391
Fax 104834 0
Email 104834 0
[email protected]
Contact person for public queries
Name 104835 0
Ms Marie van der Plas
Address 104835 0
IQVIA
8/201 Pacific Hwy,
St Leonards NSW 2065
Australia

Country 104835 0
Australia
Phone 104835 0
+614037642391
Fax 104835 0
Email 104835 0
[email protected]
Contact person for scientific queries
Name 104836 0
Ms Marie van der Plas
Address 104836 0
IQVIA
8/201 Pacific Hwy,
St Leonards NSW 2065
Australia

Country 104836 0
Australia
Phone 104836 0
+614037642391
Fax 104836 0
Email 104836 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No plans at the moment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.