Clinical trial NCT00063609: The Effect of Zoledronic Acid on Bone Loss in Prostate Cancer Patients Undergoing Androgen Deprivation Therapy
Official title: The Effect of Zoledronic Acid Compared to Placebo on Bone Mineral Density in Patients Undergoing Androgen Deprivation Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Bone Loss
Osteoporosis
Bone Mineral Density
Androgen Deprivation Therapy
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2003-07-03
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: * 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

Primary outcomes:
measure: Percent change in bone mineral density of the lumbar spine (L2-L4) at one year.
Secondary outcomes:
measure: Percent changes in bone mineral density of the total hip
measure: biochemical markers of bone turnover at one year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Millennium Therapeutics & Research
state: Alabama
city: Huntsville
country: United States
facility: Medical Affiliated Research Center
state: Alabama
city: Anchorage
country: United States
facility: Alaska Clinical Research Center
state: Alaska
city: Tucson
country: United States
facility: Advanced Clinical Therapeutics
state: Arizona
city: Tucson
country: United States
facility: Donald Gleason, MD
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Urology
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Urology Med. Center
state: California
city: Long Beach
country: United States
facility: Atlantic Urological Medical Group
state: California
city: San Diego
country: United States
facility: San Diego Uro. Research
state: California
city: Torrance
country: United States
facility: Western Clinical Research
state: California
city: Hartford
country: United States
facility: Connecticut Surgical Group
state: Connecticut
city: New Britain
country: United States
facility: Grove Hill Urology
state: Connecticut
city: Daytona Beach
country: United States
facility: Atlantic Urological Associates
state: Florida
city: Miami
country: United States
facility: University of Miami School of Medicine, Dept. of Urology
state: Florida
city: New Port Richey
country: United States
facility: Advanced Research Institute, Inc.
state: Florida
city: Ocala
country: United States
facility: Urosearch
state: Florida
city: Tallahassee
country: United States
facility: Southeastern Urological Center, PA
state: Florida
city: Evansville
country: United States
facility: Medisphere Medical Research Center, LLC
state: Indiana
city: Des Moines
country: United States
facility: The Iowa Clinic, PC, Iowa Urology Research
state: Iowa
city: Owings Mills
country: United States
facility: Summitt Clinical Research
state: Maryland
city: Southfield
country: United States
facility: Millennium Medical Center
state: Michigan
city: Springfield
country: United States
facility: Quality Clinical Research LLC
state: Nebraska
city: Marlton
country: United States
facility: Associated Urologic Specialist, PA
state: New Jersey
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: West Orange
country: United States
facility: Associates In Urology, LLC
state: New Jersey
city: Garden City
country: United States
facility: AccuMed Research Associates
state: New York
city: Garden City
country: United States
facility: Urological Surgeons of L.I.
state: New York
city: Staten Island
country: United States
facility: Staten Island Urological Research, PC
state: New York
city: Cincinnati
country: United States
facility: The Urology Group
state: Ohio
city: Columbus
country: United States
facility: Urological Associates, Inc.
state: Ohio
city: Mount Vernon
country: United States
facility: Mount Vernon Urological Associates
state: Ohio
city: Eugene
country: United States
facility: Oregon Urology Specialists
state: Oregon
city: Portland
country: United States
facility: The Urology Clinic
state: Oregon
city: Allentown
country: United States
facility: Urologic Associates of Allentown
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Triangle Urological Group
state: Pennsylvania
city: Providence
country: United States
facility: Urologic Surgeons of New England, P.C.
state: Rhode Island
city: Providence
country: United States
facility: University Urological Research Institute
state: Rhode Island
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Germantown
country: United States
facility: Integrity Clinical Research, LLC
state: Tennessee
city: San Antonio
country: United States
facility: Urology San Antonio Research
state: Texas
city: Salt Lake City
country: United States
facility: Salt Lake Research
state: Utah
city: Seattle
country: United States
facility: Seattle Urological Associates
state: Washington
city: Spokane
country: United States
facility: Rockwood Clinic
state: Washington
Study officials:
References: