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CMX Research Inc. Designed and Initiated Trials

The following clinical trials were designed, executed and monitored by CMX Research Inc..

• 1)  Bone Health Observational Study (BHOS)

The BHOS study, sponsored by AstraZeneca, was initiated in October of 2007 by CMX Research Inc. with the intention of tracking the bone health of patients who are taking Zoladex^® for the treatment of prostate cancer.  Over the course of 5 years, 450 patients are to be tracked by investigators using an online database that was designed specifically for this study.  Due to the excellent patient enrollment achieved by the CMX Research Inc. network sites, AstraZeneca announced an extension of 150 patients in June of 2009, increasing the patient total to 600.

• 2)  Eligard^® Observational Registry

The Eligard^® Observational Registry, sponsored by Sanofi Aventis, was launched in June of 2009.  This study is designed to track 300 patients over a 3 year period who are taking Eligard^® for the treatment of prostate cancer.  This study aims to identify baseline characteristics that are associated with achieving hormone refractory status.  In addition this study will collect data on patient demographics, medical history, bone health and overall health.  A specialized database has been created for this study and is proving to be an extremely efficient method for data capture. 

• 3)  The Effects Of Intravesical Injection of BOTOX^® on Patients with Urinary Urgency and Frequency without Incontinence due to OAB

This study is examining the efficacy and safety of intravesical Botox^® in dry OAB patients.  20 patients were enrolled into this study from 4 sites and standard voiding diaries and quality of life questionnaires over a 12 month period were used to gauge the effectiveness and safety of the Botox^® treatment.  Preliminary results from this study show that one injection of Botox^® significantly reduced the micturition frequency and urgencies (according to the IUSS surveys).  Data collection from this trial is ongoing.

• 4)  A Randomized, Single-Blind, Placebo-Controlled, Multicentre Study to Evaluate the Effect of Risedronate and Placebo on Bone Mineral Density in Men Undergoing Androgen Deprivation Therapy with Leuprolide Acetate

This study was designed to determine if risedronate, an orally-active bisphosphonate, would increase the lumbar spine bone mineral density (BMD) in men with non-metastatic prostate cancer undergoing ADT with leuprolide acetate, when compared to a placebo.  160 patients were randomized from 20 sites across Canada and tracked for 1 year.  Patients were to take 35mg of risedronate once per week, as well as daily calcium and vitamin D supplements.  BMD of the lumbar spine was assessed at baseline and on completion of the trial.  Data from this trial is currently being analyzed.

• 5)  Effect of Zometa on the Loss of Bone Mass Associated with Androgen Blockade for Prostate Cancer

This study was designed to determine the effect of Zometa on the loss of bone mineral density (BMD) that is associated with androgen deprivation therapy.  200 patients from 25 sites were randomized and received 10.8 mg goserelin acetate (GOS) alone or GOS plus 4 mg zoledronic acid (ZOL) via 15-minute infusion every 3 months for 1 year.  In addition, all patients received daily vitamin D and calcium supplements.  The lumbar spine BMD of patients was evaluated at baseline, at 12 months and 24 months after the initial baseline measurement.  It was found that administration of GOS alone caused a decrease in BMD from baseline at 12 and 24 months, especially in the lumbar spine and femoral neck in patients with hormone-sensitive prostate cancer (HSPC).