Trial Status - Open to Recruitment
Hand Osteoarthritis: investigating Pain Effects in a randomised placebo-controlled feasibility study of estrogen-containing therapy (HOPE-e)
HOPE-e is investigating the feasibility of using an estrogen-containing therapy in post-menopausal women with painful small joint hand osteoarthritis.
Hand osteoarthritis (OA) affects over 2 million people in the UK, causing pain and functional difficulties for many. Painful hand OA affects 8% of women and 3% of men over the age of 45 years.Currently there is no cure. There are few evidence-based interventions other than pain relief and exercise, which are often inadequate.
Around 90% of those seeking specialist care for symptomatic hand OA are female. Hand OA is more common in women, especially around the time of menopause, when levels of the hormone estrogen fall. Estrogen-containing therapy appears to protect from progression of knee and hip OA. However, to date there have been no randomised trials testing estrogen-containing therapy in individuals with symptomatic hand OA.
Our long-term aim is to find out whether giving estrogen-containing therapy to women after the menopause improves hand OA symptoms.
We want to test whether we could deliver a full trial to test whether estrogen-containing therapy improves pain in post-menopausal women with hand OA. To do this we will test whether people are prepared to be recruited and randomised to this type of study.
The secondary objectives are to:
- Generate proof-of concept data on whether estrogen-containing therapy improves hand pain, menopause symptoms, joint appearance and joint function in post-menopausal women with hand OA.
- Explore the methods of data collection which would be used in a future full-size trial.
- Determine the acceptability of the study design and treatment.
The design is a 2-arm double-blind randomised placebo-controlled intervention to test the feasibility of using a licensed drug for an alternative indication. The study will examine the feasibility of a full trial, including the following: recruitment, acceptability of randomisation, selection and acceptability of the proposed outcomes and acceptability and tolerability of the medication.
- Sample Size: 30-90 patients will be recruited from 3 sites in the UK: Nuffield Orthopaedic Centre, Oxford; Charing Cross Hospital, London and White Horse Medical Practice, Faringdon.
- Population: Postmenopausal women aged 40-65 years
- Study Visits:There are 5 study visits and one telephone call over a 7-month period. In addition, some participants will be invited to an optional focus group.