Prostate Cancer Clinical Trial
Official title:
The Effect of Zoledronic Acid Compared to Placebo on Bone Mineral Density in Patients Undergoing Androgen Deprivation Therapy
| Verified date | September 2017 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to compare the effect of an investigational drug used
intravenously and placebo administered every three months for one year, on bone loss
associated with initial androgen deprivation) in men with prostate cancer without metastasis.
In order to participate in this trial male patients must be 18 years of age or older and have
been diagnosed with prostate cancer without metastasis and within one year of starting their
androgen deprivation therapy at the day of randomization onto this trial. In addition,
patients who have undergone a recent orchiectomy (or"ke-ek'te-me) (removal of one or two
testes) are eligible to participate.
Patients who received any prior bisphosphonate therapy or prior treatment with systemic
corticosteroids within in the past 12 months are not eligible to participate. Also patients
who are receiving treatment for osteoporosis are not eligible to participate.
Inclusion into this clinical trial with this investigational drug is based on the protocol
entry criteria and evaluation from a participating trial investigator.
| Status | Completed |
| Enrollment | 200 |
| Est. completion date | April 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility |
- Histologically confirmed diagnosis of carcinoma of the prostate - No distant metastases (stage TNMO) (ie. prostate cancer without metastases) - Patients within one year at the day of randomization from initiation of androgen deprivation therapy with a LHRH agonist (with or without an antiandrogen) and with the intended duration of androgen deprivation therapy of at least 12 months. Patients may also enter if they have received an orchiectomy (or"ke-ek'te-me) within two weeks of visit 1 - Patients who received any prior bisphosphonate therapy in the past 12 months will be excluded - Patients who are currently receiving diethylstilbesterol (DES) or PC-SPES (treatment for osteoporosis) will be excluded - Patients who have received prior treatment with systemic corticosteroids within the past 12 months will be excluded (short term corticosteroid therapy, e.g. to prevent/treat chemotherapy-induced nausea/vomiting or for acute illness like asthma exacerbation, is acceptable) - Other eligibility criteria may apply |
| Country | Name | City | State |
|---|---|---|---|
| United States | Urologic Associates of Allentown | Allentown | Pennsylvania |
| United States | Advanced Urology Med. Center | Anaheim | California |
| United States | Alaska Clinical Research Center | Anchorage | Alaska |
| United States | Millennium Therapeutics & Research | Birmingham | Alabama |
| United States | The Urology Group | Cincinnati | Ohio |
| United States | Urological Associates, Inc. | Columbus | Ohio |
| United States | Atlantic Urological Associates | Daytona Beach | Florida |
| United States | The Iowa Clinic, PC, Iowa Urology Research | Des Moines | Iowa |
| United States | Oregon Urology Specialists | Eugene | Oregon |
| United States | Medisphere Medical Research Center, LLC | Evansville | Indiana |
| United States | AccuMed Research Associates | Garden City | New York |
| United States | Urological Surgeons of L.I. | Garden City | New York |
| United States | Integrity Clinical Research, LLC | Germantown | Tennessee |
| United States | Connecticut Surgical Group | Hartford | Connecticut |
| United States | Medical Affiliated Research Center | Huntsville | Alabama |
| United States | Arkansas Urology | Little Rock | Arkansas |
| United States | Atlantic Urological Medical Group | Long Beach | California |
| United States | Associated Urologic Specialist, PA | Marlton | New Jersey |
| United States | University of Miami School of Medicine, Dept. of Urology | Miami | Florida |
| United States | Morristown Memorial Hospital | Morristown | New Jersey |
| United States | Mount Vernon Urological Associates | Mount Vernon | Ohio |
| United States | Carolina Urologic Research Center | Myrtle Beach | South Carolina |
| United States | Grove Hill Urology | New Britain | Connecticut |
| United States | Advanced Research Institute, Inc. | New Port Richey | Florida |
| United States | Urosearch | Ocala | Florida |
| United States | Summitt Clinical Research | Owings Mills | Maryland |
| United States | Albert Einstein Medical Center | Philadelphia | Pennsylvania |
| United States | Triangle Urological Group | Pittsburgh | Pennsylvania |
| United States | The Urology Clinic | Portland | Oregon |
| United States | University Urological Research Institute | Providence | Rhode Island |
| United States | Urologic Surgeons of New England, P.C. | Providence | Rhode Island |
| United States | Salt Lake Research | Salt Lake City | Utah |
| United States | Urology San Antonio Research | San Antonio | Texas |
| United States | San Diego Uro. Research | San Diego | California |
| United States | Seattle Urological Associates | Seattle | Washington |
| United States | Millennium Medical Center | Southfield | Michigan |
| United States | Rockwood Clinic | Spokane | Washington |
| United States | Quality Clinical Research LLC | Springfield | Nebraska |
| United States | Staten Island Urological Research, PC | Staten Island | New York |
| United States | Southeastern Urological Center, PA | Tallahassee | Florida |
| United States | Western Clinical Research | Torrance | California |
| United States | Advanced Clinical Therapeutics | Tucson | Arizona |
| United States | Donald Gleason, MD | Tucson | Arizona |
| United States | Associates In Urology, LLC | West Orange | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percent change in bone mineral density of the lumbar spine (L2-L4) at one year. | |||
| Secondary | Percent changes in bone mineral density of the total hip | |||
| Secondary | biochemical markers of bone turnover at one year |
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