Testosterone to treat men with painful osteoarthritis of the knee
- Conditions
- Knee OsteoarthritisMusculoskeletal - Osteoarthritis
- Registration Number
- ACTRN12619001691134
- Lead Sponsor
- awley Pharmaceuticals Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Male
- Target Recruitment
- 30
Key inclusion criteria adult men with significant knee OA in accordance with ACR guidelines who are able to provide informed consent
Inclusion criteria
-Aged 40-74 years
-Men with significant knee pain on most days (defined as VAS>40mm)
-Meet American College of Rheumatology (ACR) clinical criteria for knee OA confirmed by a rheumatologist
-Baseline testosterone less than or equal to 14nmol/L
Exclusion criteria
-Major knee surgery within the last 3 months
-Major knee trauma/ significant knee injury within the last 6 months
-Arthroscopy or open surgery in the index knee in the last 12 months
-Injections of corticosteroids (last 3 months) or hyaluronic acid (last 6 months)
-Organic hypogonadism
-History of prostate cancer
-Suspected malignancy on DRE
-Elevated PSA
-Elevated haematocrit
-Other forms of inflammatory arthritis
-Active cardiovascular disease (unstable angina, myocardial infarction, stroke, transient ischaemic attack, or revascularisation procedure within the past 12 months)
-Other major co-morbidity (eg advanced lung disease or cancer)
-Use of androgens or anti-androgen drugs in past 12 months
-Untreated hypertension
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome: Physical function as assessed in performance based tests. Specifically <br>- 30-s chair-stand test <br>- 40m fast paced walk test <br>- Stair climb test <br>- Timed up and go test <br>- 6 minute walk test <br>[Time points: function will be measured as above at week 0 and week 12 ]
- Secondary Outcome Measures
Name Time Method Pain [As recorded in individualised patient diaries <br>Change in knee pain (total WOMAC pain, weight bearing and non–weight bearing pain), all time points.<br>Assessed at each visit using a visual analogue scale <br>];Muscle strength [Dynamometry in the lower limbs (involving both lower limbs simultaneously) at weeks 0 and 12 (mainly measures quadriceps and hip flexors which are important muscle groups for knee OA) ]