Duration of Suppression of Bone Turnover Following Treatment With Zoledronic Acid in Men With Metastatic CRPC (SubDueP)
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|ClinicalTrials.gov Identifier: NCT01062503|
Recruitment Status : Completed
First Posted : February 4, 2010
Last Update Posted : April 27, 2015
|Condition or disease||Intervention/treatment|
|Metastatic Prostate Cancer Bone Metastasis||Drug: Zoledronic acid|
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:
- To estimate the proportion of patients with suppression of bone turnover at 12 weeks after administration of a single dose of ZA.
- To estimate the distribution of duration of suppression of bone turnover up to 12 weeks after administration of ZA.
- To evaluate the frequency of SREs experienced by patients in this population.
- To measure quality of life and presence of bone pain over a 12 week period in this patient population by utilizing the Functional Assessment of Cancer Therapy - Bone Pain (FACT-BP) and Brief Pain Inventory (BPI) questionnaires.
|Study Type :||Observational|
|Actual Enrollment :||48 participants|
|Official Title:||Duration of Suppression of Bone Turnover Following Treatment With Zoledronic Acid in Men With Metastatic Castration Resistant Prostate Cancer|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
- Drug: Zoledronic acid
ZA at a dose of 4mg will be administered by intravenous infusion over 15 minutes in at least 100mls of salineOther Name: 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01062503
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G2M9|
|Principal Investigator:||Ian F Tannock, MD, PhD||University Health Network, Toronto|