An observational study in Prostate Cancer, sponsored by CMX Research. Completed at 40 sites in Canada. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-28.
Sponsored by CMX Research · Observational
Prostate Cancer patients treated with LHRH agonists (e.g., goserelin) lose Bone Mineral Density (BMD). Using a prospective, observational study design, we propose that monitoring how physicians manage Cancer Treatment Induced Bone Loss(CTIBL) in their patients. The gold standard for evaluating BMD is dual energy x-ray absorptiometry (DEXA). The proposed study will provide some of the first prospective data on the rates of Skeletal Related Events (SREs) in prostate cancer patients undergoing ADT and help develop official guidelines on the use of DEXA screening for prostate cancer patients.
A consequence of ADT is the gradual bone loss, so-called cancer treatment induced bone loss (CTIBL). The current standard of care is the addition of Vitamin D and Calcium upon the initiation of ADT. Moreover, bisphosphonates are now being considered to treat and prevent CTIBL. However, bisphosphonates are costly, thus there is a desire to identify or target a specific subset of patients who would most benefit from the treatment.
By obtaining baseline BMD and monitoring for Skeletal Related Events (SREs), we hope to identify that specific sub-set of patients who would most benefit from the treatment. Using a prospective, observational study design, we propose monitoring how physicians manage CTIBL in their patients.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 599 is above the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →CMX Research is the lead sponsor of 8 studies on the registry; none are open to participants now.
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primary care clinics
Exclusion Criteria:
Normal - BMD with T-score at or above -1.0
Osteopenic - BMD with T-score between -1.1 and -2.4
Osteoporotic - BMD with T-score at or below -2.5
Bone Mineral Density of the lumbar spine
Time frame: 12 months
Overall Safety
Time frame: 12 Months
Plan to share: Undecided
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CMX Research