An observational study in Metastatic Prostate Cancer and Bone Metastasis, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-27.
Sponsored by University Health Network, Toronto · Observational
Bone is the most common site of metastases in prostate cancer and bone complications cause substantial morbidity to this population. Phase III studies have shown that zoledronic acid is effective in decreasing the morbidity associated with bone metastases. Zoledronic acid (ZA) is generally well tolerated but may have side effects such as hypocalcemia, renal impairment and osteonecrosis of the jaw. Administration of ZA as infrequently as once yearly is sufficient to prevent osteopenia or osteoporosis. The optimal treatment interval is unknown, but the drug is often empirically administered every 3-4 weeks. The cost of such treatment is high, and the risk of exposing patients (especially those at low risk) to potential serious side effects with uncertain benefit warrants investigation. This study will determine the duration of suppression of bone turnover in prostate cancer patients with bone metastases following a single infusion of Zoledronic Acid and its effect on quality of life.
The bone is the most common site of metastasis in men with prostate cancer, and that bone metastases are associated with a significant risk of SREs. Prevention and delay in onset of SREs has been demonstrated with use of ZA. The optimal dosing frequency of ZA is not known in this population but it is usually given every 3-4 weeks, whereas injections as infrequently as once yearly protect from bone loss in patients without bone metastases who are receiving ADT. uNTX, sCTX and BAP are markers of bone turnover and bone formation that are suppressed in response to ZA and are associated with the likelihood of development of an SRE. In this study, we propose to determine the duration of suppression of bone turnover (all uNTX, sCTX and BAP) in response to a single dose of ZA in patients with castration resistant prostate cancer metastatic to bone.
Our objectives for this study:
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 48 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
This is a non-randomized observational study
Exclusion Criteria:
ZA at a dose of 4mg will be administered by intravenous infusion over 15 minutes in at least 100mls of saline
Also known as: Zometa
Patients given single dose of Zoledronic Acid 4mg IV
Time frame: baseline
Brief Pain Inventory Location Questionnaire
Time frame: Baseline, Q6weeks, Q12weeks, 26weeks
FACT-BP Quality of Life Questionnaire
Time frame: Baseline, Q6weeks, Q12weeks, 26weeks
We will monitor for uNTX, sCTX, BAP (fasting morning sample)
Time frame: Baseline, Q3wks, Q6wks, Q9wks Q12wks
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto