TerminatedPhase 3

Zolendronate for the Prevention of Bone Loss in Men w/ Prostate CA on Long-Term Androgen Deprivation

Stopped: Closed by the research committee

United States53 participantsStarted 2003-03

Plain-language summary

RATIONALE: Zoledronate may prevent bone loss associated with long term androgen deprivation therapy. It is not yet known whether zoledronate combined with calcium is more effective than calcium alone in preventing bone loss. PURPOSE: Randomized phase III trial to compare the effectiveness of zoledronate combined with calcium with that of calcium alone in preventing bone loss in patients with stage III or stage IV prostate cancer who have received long-term androgen deprivation therapy.

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.

DISEASE CHARACTERISTICS: * Histologically confirmed prostate cancer * Stage III or IV disease * Received at least 3 months of prior androgen deprivation therapy (no maximum amount/time) by either surgical or medical castration * Medical castration may be by intermittent or continuous androgen suppression via single- or combined-drug androgen blockade * Continued concurrent androgen deprivation therapy required throughout study participation * No bone metastases by baseline bone scan PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 1 year Hematopoietic * Not specified Hepatic * Bilirubin less than 3 times upper limit of normal (ULN) * AST and ALT less than 3 times ULN * No chronic liver disease Renal * Creatinine no greater than 2.0 mg/dL Other * Fertile patients must use effective contraception * No Paget's disease * No Cushing's disease * No hyperthyroidism * No hyperprolactinemia PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Prior chemotherapy for prostate cancer allowed Endocrine therapy * See Disease Characteristics * More than 12 months since prior suppressive doses of thyroxine or calcitonin * More than 6 months since prior corticosteroids * Concurrent corticosteroids allowed (after enrollment on study) Radiotherapy * Prior radiotherapy for prostate cancer allowed Surgery * See Disease Characteristics Other * More than 12 months since prior bisphosphonate th…

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

Bone Density Change as Measured by Dual-energy X-ray Absorptiometry From Baseline to 13 Months

Timeframe: Bone scan taken at baseline and month 13

Trial details

NCT IDNCT00058188

SponsorNorthwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-11

Results submitted2020-10-23

View on ClinicalTrials.gov More Osteoporosis trials