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Treatment Side Effects and Changes to Physical Function in Newly-Diagnosed Polymyalgia Rheumatica

Characterisation of Glucocorticoid Toxicity and Effects on Physical Function in Newly-Diagnosed Polymyalgia Rheumatica

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12618001522202
Enrollment
68
Registered
2018-09-11
Start date
2019-03-22
Completion date
2022-01-12
Last updated
2024-02-05

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

Conditions

None listed

Brief summary

Polymyalgia rheumatica (PMR) is the most common inflammatory rheumatic condition in the elderly, and is typically treated with glucocorticoids (commonly known as 'cortisone' or 'steroids'). This study aims to examine the possible side effects of standard glucocorticoid therapy in people with a new diagnosis of PMR, with a particular focus on changes to muscle and bone health, including the incidence and prevalence of sarcopenia. People with a recent diagnosis of PMR, as well as people who have never been diagnosed with PMR, will undergo a series of assessments including questionnaires, physical examination, blood tests, imaging tests and physical tests in a dedicated exercise laboratory. Assessments will be repeated in all participants after 78 weeks, in order to examine the changes that occur. It is hypothesised that participants with PMR will demonstrate a greater decline in their muscle and bone health, and a higher incidence of sarcopenia, compared to participants without PMR. Ultimately, this would lead to a greater awareness of the need to address muscle and bone health during treatment of PMR.

Interventions

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)

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.

Sponsors

Austin Health
Lead SponsorHospital

Eligibility

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

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

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026