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Characterization of patients with established polymyalgia rheumatica

Characterization of patients with established polymyalgia rheumatica treated with long-term glucocorticoid therapy

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12616001084471
Enrollment
30
Registered
2016-08-11
Start date
2016-08-15
Completion date
2017-12-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Despite the fact that Polymyalgia Rheumatica (PMR) is the most common inflammatory rheumatic disease of the elderly, it is under-researched and poorly understood. With no diagnostic tests available, diagnosis is dependent upon a history of muscle pain and stiffness in the shoulder and hip regions, combined with raised inflammation levels in the blood. Treatment consists of prednisolone (commonly referred to as “cortisone”) prescribed in a “one size fits all” approach that lasts ~12 months in duration. However, the way in which PMR patients’ symptoms respond is very variable; some improve almost overnight, whilst other individuals require higher doses for much longer periods of time. Unfortunately, such long-term prednisolone use can result in many complications including osteoporosis, weight gain, high blood pressure and diabetes. This project therefore aims to identify the characteristics of PMR patients that have failed standard cortisone treatment and remain on long-term prednisolone. In addition, prednisolone-related treatment complications will be documented.

Interventions

Patients with an established diagnosis of PMR attending the Austin Hospital or referred by primary care providers and Rheumatologists in the Hospital’s catchment area (north-eastern suburbs of Melbourne, Victoria) will be invited to partake. After appropriate consent, demographic data, a range of questionnaires on symptoms and prednisolone-related treatment complications, and a general physical examination will be carried out as part of the initial visit (performed in the Rheumatology Departmen

Patients with an established diagnosis of PMR attending the Austin Hospital or referred by primary care providers and Rheumatologists in the Hospital’s catchment area (north-eastern suburbs of Melbourne, Victoria) will be invited to partake. After appropriate consent, demographic data, a range of questionnaires on symptoms and prednisolone-related treatment complications, and a general physical examination will be carried out as part of the initial visit (performed in the Rheumatology Department, Heidelberg Repatriation Hospital. time commitment 2 hours). Participants will then have a set of blood tests performed, along with the following imaging tests: - Bilateral hand x-rays (performed during initial visit); - Ultrasound of the wrists and shoulders (performed during initial visit); - Whole body Positron Emission Tomography (PET)/Computed Tomography (CT) scan (performed in Molecular Imaging and Therapy at Austin Hospital, time commitment 2 hours); - Whole body composition DEXA scan (performed in Bone and Mineral Research Unit, time commitment 1 hour). A subsequent visit will be arranged to the Centre for Physical Activity and Nutrition at Deakin University (time commitment 2 hours), Burwood Campus where participants will undergo a range of muscle strength, power and function tests in a dedicated laboratory. A peripheral quantitative CT scan (a test capable of measuring muscle size and bone strength) will also be performed during this visit. In selected participants, targeted MRI may also be performed at a later date in order to permit correlation of whole body PET/CT findings (performed in the Radiology Department at Austin Hospital, time commitment 1 hour). At the conclusion of the study (no longer than one month from enrolment to completion of subsequent visit), the characteristics of participants with established PMR will be compared with those from a prior study at Austin Health of patients with newly diagnosed disease. It is hypothesized that this information will further delineate a distinct subset of patients refractory to the “one size fits all” cortisone approach, thereby permitting further study of alternate therapy in this group. In addition, the complications of long-term prednisolone use in PMR will be better appreciated.

Sponsors

Austin Health
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Diagnosis of PMR (as defined by the 2012 European League Against Rheumatism/American College of Rheumatology [EULAR/ACR] Classification Criteria) at least 18 months earlier; AND Long-term treatment with low-dose glucocorticoid therapy (stable prednisolone dose greater than or equal to 5mg and less than or equal to 15mg oral daily for at least 2 months duration).

Exclusion criteria

Prior diagnosis or current symptoms suggestive of Giant Cell Arteritis (GCA [headache, jaw claudication, scalp tenderness or sudden visual disturbance]); Active malignancy; Active infection; Active neuromuscular disease; Other inflammatory conditions eg. Rheumatoid Arthritis (RA); Chronic pain syndromes; Treatment with concomitant Disease Modifying Anti-Rheumatic Drugs (DMARD).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026