Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001522202
Ethics application status
Approved
Date submitted
7/09/2018
Date registered
11/09/2018
Date last updated
28/01/2024
Date data sharing statement initially provided
19/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Treatment Side Effects and Changes to Physical Function in Newly-Diagnosed Polymyalgia Rheumatica
Scientific title
Characterisation of Glucocorticoid Toxicity and Effects on Physical Function in Newly-Diagnosed Polymyalgia Rheumatica
Secondary ID [1] 296037 0
Nil known
Universal Trial Number (UTN)
U1111-1220-1061
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polymyalgia Rheumatica 309582 0
Sarcopenia 309583 0
Condition category
Condition code
Inflammatory and Immune System 308405 308405 0 0
Autoimmune diseases
Musculoskeletal 308406 308406 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with a recent diagnosis of polymyalgia rheumatica (PMR) will be recruited, together with age- and gender-matched controls.

Data will be collected at two time points, 78 weeks apart.

The initial tests will be undertaken 12 weeks after the patient first commences prednisolone for their PMR.
Assessments will include:
- Questionnaires
- Blood tests
- Bilateral hand x-rays (in PMR participants only)
- Activity monitors
- Whole body composition DEXA (including vertebral fracture assessment)
- Peripheral quantitative CT scan
- Tests of muscle strength, power and function in a dedicated exercise laboratory

Further tests will occur 78 weeks later. Data collected will be the same as the initial tests, with the exception of bilateral hand x-rays (which will not be repeated), and not all blood tests will be repeated.
Intervention code [1] 312376 0
Not applicable
Comparator / control treatment
Control participants will be age- and gender-matched individuals without a diagnosis of PMR, who are not receiving regular prednisolone therapy for any other condition.
Control group
Placebo

Outcomes
Primary outcome [1] 307369 0
For participants who were not already sarcopenic, the proportion who have developed sarcopenia at the 78-week assessment o EWGSOP definition of sarcopenia o FNIH definition of sarcopenia
Timepoint [1] 307369 0
78 weeks after initial assessment
Primary outcome [2] 307370 0
Prevalence of sarcopenia at 78-week assessment o EWGSOP definition of sarcopenia o FNIH definition of sarcopenia
Timepoint [2] 307370 0
78 weeks after initial assessment
Secondary outcome [1] 351656 0
Prevalence of pre-sarcopenia (EWGSOP definition)
Timepoint [1] 351656 0
78 weeks after initial assessment
Secondary outcome [2] 351657 0
Prevalence of severe sarcopenia (EWGSOP definition)
Timepoint [2] 351657 0
78 weeks after initial assessment
Secondary outcome [3] 351658 0
36-Item Short Form Survey (SF36)
Timepoint [3] 351658 0
Initial assessment and 78 weeks
Secondary outcome [4] 351659 0
Health Assessment Questionnaire – Disability Index (HAQ-DI)
Timepoint [4] 351659 0
Initial assessment and 78 weeks
Secondary outcome [5] 351660 0
Hospital Anxiety and Depression Scale (HADS)
Timepoint [5] 351660 0
Initial assessment and 78 weeks
Secondary outcome [6] 351661 0
Pittsburgh Sleep Quality Index (PSQI)
Timepoint [6] 351661 0
Initial assessment and 78 weeks
Secondary outcome [7] 351662 0
Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAF-MDQ)
Timepoint [7] 351662 0
Initial assessment and 78 weeks
Secondary outcome [8] 351663 0
SARC-F questionnaire
Timepoint [8] 351663 0
Initial assessment and 78 weeks
Secondary outcome [9] 351664 0
Habitual physical activity questionnaire (Physical Activity Scale for the Elderly [PASE] questionnaire)
Timepoint [9] 351664 0
Initial assessment and 78 weeks
Secondary outcome [10] 351665 0
Activity level measured by activity monitors - time spent in moderate & vigorous physical activity
Timepoint [10] 351665 0
Initial assessment and 78 weeks
Secondary outcome [11] 351666 0
Cytokine profile (plasma assay)
Timepoint [11] 351666 0
Initial assessment and 78 weeks
Secondary outcome [12] 351669 0
Lower limb peak muscle power, measured from maximum leg press using Keiser pneumatic resistance training equipment fitted with A420 electronics
Timepoint [12] 351669 0
Initial assessment and 78 weeks
Secondary outcome [13] 351670 0
Bilateral maximal isometric grip strength, measured using a hand-held dynamometer (Jamar dynamometer)
Timepoint [13] 351670 0
Initial assessment and 78 weeks
Secondary outcome [14] 351672 0
Stair climbing ability, measured using the Leonardo Mechanography Stair Test (Novotec Medical, Pforzheim, Germany)
Timepoint [14] 351672 0
Initial assessment and 78 weeks
Secondary outcome [15] 351674 0
Short Physical Performance Battery (SPPB)
Timepoint [15] 351674 0
Initial assessment and 78 weeks
Secondary outcome [16] 351675 0
Choice Stepping Reaction Time (CSRT)
Timepoint [16] 351675 0
Initial assessment and 78 weeks
Secondary outcome [17] 351676 0
Four-Step Square Test (FSST)
Timepoint [17] 351676 0
Initial assessment and 78 weeks
Secondary outcome [18] 351705 0
Incidence of pre-sarcopenia (EWGSOP definition)
Timepoint [18] 351705 0
Initial assessment and 78 weeks
Secondary outcome [19] 351706 0
Incidence of severe sarcopenia (EWGSOP definition)
Timepoint [19] 351706 0
Initial assessment and 78 weeks
Secondary outcome [20] 351707 0
Lean mass on whole body composition DEXA scan
Timepoint [20] 351707 0
Initial assessment and 78 weeks
Secondary outcome [21] 351708 0
Fat mass on whole body composition DEXA scan
Timepoint [21] 351708 0
Initial assessment and 78 weeks
Secondary outcome [22] 351709 0
Bone mass on whole body composition DEXA scan
Timepoint [22] 351709 0
Initial assessment and 78 weeks
Secondary outcome [23] 351710 0
Muscle cross-sectional area on peripheral quantitative CT scan of radius
Timepoint [23] 351710 0
Initial assessment and 78 weeks
Secondary outcome [24] 351711 0
Subcutaneous fat cross-sectional area on peripheral quantitative CT scan of radius
Timepoint [24] 351711 0
Initial assessment and 78 weeks
Secondary outcome [25] 351712 0
Muscle density on peripheral quantitative CT scan of radius
Timepoint [25] 351712 0
Initial assessment and 78 weeks
Secondary outcome [26] 351713 0
Cortical bone thickness on peripheral quantitative CT scan of radius
Timepoint [26] 351713 0
Initial assessment and 78 weeks
Secondary outcome [27] 351714 0
Cortical bone density on peripheral quantitative CT scan of radius
Timepoint [27] 351714 0
Initial assessment and 78 weeks
Secondary outcome [28] 351715 0
Bone strength strain index on peripheral quantitative CT scan of radius
Timepoint [28] 351715 0
Initial assessment and 78 weeks
Secondary outcome [29] 351716 0
Muscle cross-sectional area on peripheral quantitative CT scan of femur and tibia
Timepoint [29] 351716 0
Initial assessment and 78 weeks
Secondary outcome [30] 351717 0
Subcutaneous fat cross-sectional area on peripheral quantitative CT scan of femur
Timepoint [30] 351717 0
Initial assessment and 78 weeks
Secondary outcome [31] 351718 0
Muscle density on peripheral quantitative CT scan of femur
Timepoint [31] 351718 0
Initial assessment and 78 weeks
Secondary outcome [32] 351719 0
Cortical bone thickness on peripheral quantitative CT scan of femur
Timepoint [32] 351719 0
Initial assessment and 78 weeks
Secondary outcome [33] 351720 0
Cortical bone density on peripheral quantitative CT scan of femur
Timepoint [33] 351720 0
Initial assessment and 78 weeks
Secondary outcome [34] 351721 0
Bone strength strain index on peripheral quantitative CT scan of femur
Timepoint [34] 351721 0
Initial assessment and 78 weeks
Secondary outcome [35] 351722 0
Muscle cross-sectional area on peripheral quantitative CT scan of tibia
Timepoint [35] 351722 0
Initial assessment and 78 weeks
Secondary outcome [36] 351723 0
Subcutaneous fat cross-sectional area on peripheral quantitative CT scan of tibia
Timepoint [36] 351723 0
Initial assessment and 78 weeks
Secondary outcome [37] 351724 0
Muscle density on peripheral quantitative CT scan of tibia
Timepoint [37] 351724 0
Initial assessment and 78 weeks
Secondary outcome [38] 351725 0
Cortical bone thickness on peripheral quantitative CT scan of tibia
Timepoint [38] 351725 0
Initial assessment and 78 weeks
Secondary outcome [39] 351726 0
Cortical bone density on peripheral quantitative CT scan of tibia
Timepoint [39] 351726 0
Initial assessment and 78 weeks

Eligibility
Key inclusion criteria
For PMR participants:
Diagnosis of PMR (as defined by the 2012 EULAR/ACR Classification Criteria)
AND
Commencement of prednisolone for PMR treatment <12 weeks prior

For control participants:
Age- and gender-matched to PMR participants
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
For PMR participants:
• Prior diagnosis or current symptoms suggestive of Giant Cell Arteritis (GCA [including headache, jaw claudication, scalp tenderness or sudden visual disturbance]);
• Active malignancy;
• Active infection;
• Active neuromuscular disease;
• Other inflammatory/autoimmune conditions requiring immunosuppression e.g. Rheumatoid Arthritis (RA);
• Chronic pain syndromes;
• Prior or current treatment with concomitant Disease Modifying Anti-Rheumatic Drugs (DMARD).

For Control Participants:
• Current or prior diagnosis of PMR;
• Current or prior diagnosis of GCA;
• Any condition requiring regular systemic glucocorticoids;
• Active malignancy;
• Active infection;
• Active neuromuscular disease;
• Any inflammatory/autoimmune conditions requiring immunosuppression e.g. Rheumatoid Arthritis (RA);
• Chronic pain syndromes.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Case control
Timing
Prospective
Statistical methods / analysis
At completion of the study period, statistical analyses will be undertaken using Stata 13.0 to compare the characteristics of participants with PMR to control participants. Parametric data will be compared using t-tests, while non-parametric data will be compared using the chi-square test or Kruskall-Wallis one-way analysis of variance. P-values of <0.05 will be classified as statistically significant. A more detailed multivariable and conditional logistic regression is also planned to control for the effects of variables such as gender, BMI and smoking status.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2019
Actual
22/03/2019
Date of last participant enrolment
Anticipated
30/01/2022
Actual
12/01/2022
Date of last data collection
Anticipated
30/07/2023
Actual
30/07/2023
Sample size
Target
100
Accrual to date
Final
68
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11824 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 11825 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment postcode(s) [1] 23951 0
3084 - Heidelberg
Recruitment postcode(s) [2] 23952 0
3081 - Heidelberg West

Funding & Sponsors
Funding source category [1] 300628 0
Hospital
Name [1] 300628 0
Austin Hospital
Country [1] 300628 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Rheumatology Department,
Level 1, North Wing,
Repatriation Campus,
300 Waterdale Road,
Heidelberg West VIC 3081
Country
Australia
Secondary sponsor category [1] 300137 0
None
Name [1] 300137 0
Address [1] 300137 0
Country [1] 300137 0
Other collaborator category [1] 280339 0
University
Name [1] 280339 0
Deakin University
Address [1] 280339 0
Institute for Physical Activity and Nutrition Research
Building J,
Burwood Campus,
221 Burwood Highway,
Burwood VIC 3125
Country [1] 280339 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301417 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 301417 0
Ethics committee country [1] 301417 0
Australia
Date submitted for ethics approval [1] 301417 0
04/09/2018
Approval date [1] 301417 0
19/12/2018
Ethics approval number [1] 301417 0
HREC/44292/Austin-2018

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86922 0
A/Prof Russell Buchanan
Address 86922 0
Rheumatology Department
Level 1 North Wing,
300 Waterdale Road,
Heidelberg West
VIC 3081
Country 86922 0
Australia
Phone 86922 0
+61 3 9496 4013
Fax 86922 0
Email 86922 0
[email protected]
Contact person for public queries
Name 86923 0
Jessica Leung
Address 86923 0
Rheumatology Department
Level 1 North Wing,
300 Waterdale Road,
Heidelberg West
VIC 3081
Country 86923 0
Australia
Phone 86923 0
+61 3 9496 4045
Fax 86923 0
Email 86923 0
[email protected]
Contact person for scientific queries
Name 86924 0
Jessica Leung
Address 86924 0
Rheumatology Department
Level 1 North Wing,
300 Waterdale Road,
Heidelberg West
VIC 3081
Country 86924 0
Australia
Phone 86924 0
+61 3 9496 4013
Fax 86924 0
Email 86924 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


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.