Cost Effectiveness Of Glucosamine Sulphate For Knee Arthritis (COGS)
Funder
National Health and Medical Research Council
Funding Amount
$448,791.00
Summary
A clinical trial, conducted in general practice, randomising 340 patients with symptomatic knee osteoarthritis to glucosamine sulphate or matching placebo tablets for 9 months. The main study outcomes will be knee pain, physical function and analgesia use. Analysis will be undertaken to identify characteristics associated with treatment responsiveness, such as high body mass index and structural disease severity. An economic analysis will be conducted alongside this trial.
A Randomised Phase III Trial Of Anastrozole For Breast Cancer Prevention In Postmenopausal Women At High Risk.
Funder
National Health and Medical Research Council
Funding Amount
$1,593,125.00
Summary
Each year over 10,000 new cases of breast cancer are diagnosed in Australia and over 2500 women die. This project (IBIS 2) is designed to continue the work started by the IBIS 1 prevention trial in determining whether a chemopreventive strategy towards breast cancer is beneficial. IBIS 1 investigated the use of tamoxifen as a preventative agent for women with moderate to increased risk of developing breast cancer and was found to prevent 48% of oestrogen receptor positive breast cancers. IBIS 2 ....Each year over 10,000 new cases of breast cancer are diagnosed in Australia and over 2500 women die. This project (IBIS 2) is designed to continue the work started by the IBIS 1 prevention trial in determining whether a chemopreventive strategy towards breast cancer is beneficial. IBIS 1 investigated the use of tamoxifen as a preventative agent for women with moderate to increased risk of developing breast cancer and was found to prevent 48% of oestrogen receptor positive breast cancers. IBIS 2 investigates anastrozole (Arimidex) as a preventative agent for women with moderate to increased risk of developing breast cancer. It is a multi-centre, randomised, double blind control trial which has the potential to benefit many millions of women worldwide. Anastrozole is an aromatase inhibitor (AI). AIs are a class of endocrine drug which have been shown to be at least as effective as tamoxifen but without the serious side effects seen with tamoxifen. Anastrozole has been shown to be 60% better than tamoxifen in preventing a second breast cancer in women already diagnosed with breast cancer. Women who participate in this study will be postmenopausal with a relative risk of at least two-fold of developing breast cancer. They will be randomised to receive either anastrozole or placebo as a daily tablet, and neither the woman nor her treating clinician will know which treatment has been allocated (double blind study). To investigate whether anastrozole effects bone density, a baseline bone density scan will be measured prior to study entry. This sub-study will investigate bone density in greater detail and the potential role of bone preserving treatment (bisphosphonate). The primary endpoint for the IBIS 2 study is the development of histologically confirmed breast cancer, invasive or non-invasive.Read moreRead less
IBIS II: A Randomised Phase III Trial Of Anastrozole For Breast Cancer Prevention In Postmenopausal Women At High Risk.
Funder
National Health and Medical Research Council
Funding Amount
$1,732,559.00
Summary
The IBIS II trial builds on the successful IBIS 1 breast cancer (BC) prevention trial in determining whether a chemopreventive strategy towards BC is beneficial. Women who are postmenopausal with an increased risk of BC are randomised to receive either anastrozole (an aromatase inhibitor) or placebo as a daily tablet. Neither the woman nor her clinician know which treatment has been allocated (double blind study). IBIS 2 has the potential to benefit many higher risk women worldwide.
VITATOPS - A Randomised Controlled Trial Of Vitamins To Prevent Stroke
Funder
National Health and Medical Research Council
Funding Amount
$391,364.00
Summary
A high level of a normal protein component in the blood (homocysteine) is fast becoming recognised as a new risk factor for premature stroke and heart disease, although it remains uncertain whether treatment with vitamins can prevent these diseases from occurring. VITATOPS is a multi-centre, double-blind, placebo-controlled trial designed to examine the efficacy and safety of multi-vitamin therapy (folate, B6 and B12) in the prevention of stroke and other types of vascular disease. The VITATOPS ....A high level of a normal protein component in the blood (homocysteine) is fast becoming recognised as a new risk factor for premature stroke and heart disease, although it remains uncertain whether treatment with vitamins can prevent these diseases from occurring. VITATOPS is a multi-centre, double-blind, placebo-controlled trial designed to examine the efficacy and safety of multi-vitamin therapy (folate, B6 and B12) in the prevention of stroke and other types of vascular disease. The VITATOPS study arises from a large body of consistent, biologically plausible evidence linking homocysteine in a dose-dependent fashion to stroke and other types of vascular disease. A simple, non-toxic, and inexpensive intervention in the form of multivitamins (folate, B6 and B12) has been shown to be highly effective at reducing homocysteine levels, irrespective of the underlying cause. All patients who are referred to a neurologist or general physician in one of the collaborating centres within six months of a stroke or transient ischaemic attack are eligible for the trial. In total, treatment will continue for a period of between 1 and 5 years. During this time, patients will be closely monitored in order to record the occurrence of any vascular events (particularly strokes and heart attacks). Neither the study investigator nor the patient will know which treatment they are receiving (i.e. it is 'double blind'). The number of vascular events in the treatment groups will be compared at the end of the study in order to determine whether vitamin treatment is beneficial. This application is for five years of support to allow the investigators to move from the pilot phase of VITATOPS in Perth to begin recruitment to the definitive trial in other centres across Australia and New Zealand. This study may have a major impact on patient management. If vitamins prove to be effective, we may recommend vitamin supplementation to all of our stroke patients in the future.Read moreRead less
Randomised Trial Of Homocysteine Lowering Treatment Of Depression In Later Life (B-VITAge)
Funder
National Health and Medical Research Council
Funding Amount
$775,530.00
Summary
The causes of depression in later life are varied and complex, but available evidence suggests that cardiovascular disease plays an important role. High homocysteine (a robust risk factor for myocardial infarction and strokes) accounts for about 20% of all cases of depression in older age. We have previously shown that treatment with vitamins B12, B6 and folate reduces homocysteine. We propose to run a trial to test if lowering homocysteine decreases the severity and prevalence of depression.