Duration of Suppression of Bone Turnover Following Treatment With Zoledronic Acid in Men With Met… (NCT01062503) | Clinical Trial Compass
CompletedNot Applicable
Duration of Suppression of Bone Turnover Following Treatment With Zoledronic Acid in Men With Metastatic CRPC
Canada48 participantsStarted 2010-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have histologically confirmed prostate cancer that has become castration resistant
* Radiological or pathological evidence of bone metastases. (Positive bone scan, MRI, or CT or pathological fracture, or pathological sample from bone biopsy showing evidence of metastatic prostate cancer)
* Patient has not yet started on BP therapy for metastatic castration resistant prostate cancer
* Renal and hepatic function within the institutional normal range or at the discretion of the Investigator
* Age ≥ 18 years
* ECOG performance status ≤ 2
* Life expectancy \>6 months
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Hypersensitivity or known allergy to bisphosphonates
* Patient who has received BP therapy for any reason within the past 1 year
* Acute or chronic renal insufficiency
* Evidence of infection/abscess on dental exam or recent dental extraction (within last 4 weeks)
* Acute pathological fracture, spinal cord compression, or hypercalcemia requiring urgent treatment (patient may enter study after acute issues are resolved)
* Patients with baseline hypocalcemia
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Patients given single dose of Zoledronic Acid 4mg IV