Risedronate to Prevent Skeletal Related Events in Patients With Metastatic Prostate Cancer Commencing Hormonal Therapy
Public ClinicalTrials.gov record NCT00216060. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Ability of Risedronate to Prevent Skeletal Related Events in Patients With Metastatic Prostate Cancer Commencing Hormonal Therapy: Hoosier Oncology Group GU02-41
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Risedronate is an orally administered pyridinyl bisphosphonate that is 36 times more potent than pamidronate and 72 times more potent than clodronate. Four randomized, double-blind trials have been carried out in patients with postmenopausal osteoporosis. In 2 of these studies, vertebral fracture incidence was reduced by a daily dose of 5 mg risedronate by up to 65% and 49% relative to placebo after 1 and 3 years, respectively. In these trials, risedronate improved lumbar spine, femoral neck, and femoral trochanter bone mineral density (BMD) at 6 months. In addition, preclinical studies have shown that risedronate is more potent than pamidronate and clodronate in inhibiting adhesion of prostate cancer cells to bone and preventing tumor cell invasion. The incidence of osteoporosis in prostate cancer patients has been well established; therefore, it is advantageous to assess the efficacy of oral bisphosphonate therapy.
Study identification
- NCT ID
- NCT00216060
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 63 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2003
- Primary completion
- Jan 31, 2008
- Completion
- Feb 29, 2008
- Last update posted
- May 25, 2016
2003 – 2008
United States locations
- U.S. sites
- 31
- U.S. states
- 17
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Center for Urological Research | La Mesa | California | 91942 | — |
| San Bernadino Urological Associates | San Bernardino | California | 92404 | — |
| Grove Hill Medical Center Urology | New Britain | Connecticut | 06052 | — |
| Innovative Surgical Resources | Tampa | Florida | 33607 | — |
| Medical & Surgical Specialists, LLC | Galesburg | Illinois | 61401 | — |
| Peoria Urological Associates | Peoria | Illinois | 61614 | — |
| Oncology Hematology Associates of SW Indiana | Evansville | Indiana | 47714 | — |
| Center for Cancer Care at Goshen Health System | Goshen | Indiana | 46527 | — |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202 | — |
| Quality Cancer Center (MCGOP) | Indianapolis | Indiana | 46202 | — |
| Urology of Indiana, LLC | Indianapolis | Indiana | 46202 | — |
| Urology Associates | Muncie | Indiana | 47303 | — |
| Northern Indiana Cancer Research Consortium | South Bend | Indiana | 46601 | — |
| Urologic Surgery Associates | Baltimore | Maryland | 21201 | — |
| Drs. Werner, Murdock and Francis PA Urology Associates | Greenbelt | Maryland | 20770 | — |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | — |
| Kansas City Urology Care | Kansas City | Missouri | 64131 | — |
| Siteman Cancer Center | St Louis | Missouri | 63110 | — |
| Nevada Urology | Reno | Nevada | 89511 | — |
| Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | — |
| Lawrenceville Urology | Trenton | New Jersey | 08648 | — |
| Accumed Research Associates | Garden City | New York | 11530 | — |
| Staten Island Urological Research, P.C. | Staten Island | New York | 10304 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Oregon Urology Specialists | Springfield | Oregon | 97477 | — |
| Urological Associates of Lancaster | Lancaster | Pennsylvania | 17604 | — |
| Triangle Urological Group | Pittsburgh | Pennsylvania | 15212 | — |
| Salt Lake Research | Salt Lake City | Utah | 84124 | — |
| David Reed, M.D. | Seattle | Washington | 98166 | — |
| Madigan Army Medical Center Urology Service | Tacoma | Washington | 98431 | — |
| Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 14 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00216060, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 25, 2016 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00216060 live on ClinicalTrials.gov.