- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00048841
Prevention of Osteoporosis in Men With Prostate Cancer
March 1, 2010 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The purpose of this two year study is to examine the safety and effectiveness of alendronate (Fosamax) for the prevention of bone loss in men with prostate cancer who are on therapy to lower their testosterone levels.
All men will receive appropriate calcium and vitamin D supplements and one to two years of alendronate therapy.
Bone density tests will be done every six months.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Prostate cancer is the most common visceral malignancy and second leading cause of cancer death in men.
While androgen ablation therapy is the cornerstone of treatment for more advanced stage disease, recent studies suggest the advantage of introducing androgen deprivation much earlier.
Because androgens are essential in maintaining skeletal integrity in men, androgen deprivation therapy constitutes a major risk factor for male osteoporosis.
We have previously demonstrated that men on chronic androgen deprivation therapy have up to 20% loss of bone.
Our hypotheses are that: 1) chronically increased bone resorption induced by long term androgen deprivation therapy in men with prostate cancer can be reversed with once weekly bisphosphonate; 2) the improvement in bone mass with bisphosphonate therapy will be reflected by changes in biochemical markers of bone turnover and will allow us to predict who will respond to therapy; and 3) following termination of bisphosphonate therapy, bone mass will be maintained despite the absence of antiresorptive therapy.
To address these hypotheses, we will enroll 84 men with stage D0 prostate cancer who have been on chronic androgen deprivation therapy in a two year, double blind, placebo controlled, randomized, modified crossover clinical design.
During the first year, subjects will be randomized to bisphosphonate therapy or placebo.
During the second year, all subjects who were on placebo will receive active treatment and all subjects who were on active treatment will be randomly assigned to continue therapy or change to placebo.
To evaluate the effect of bisphosphonate on preventing bone loss, we will assess bone mass of the spine, total hip, total body, and forearm by dual-energy X-ray absorptiometry.
For hypothesis 2, we will assess markers of bone resorption and formation to determine if early changes in markers are associated with long term changes in bone mass.
For hypothesis 3, we will continue to follow bone mass and biochemical markers of bone turnover between months 12 and 24 to examine rates of change when antiresorptive therapy is terminated.
Few data are available on the prevention of bone loss in men on androgen deprivation therapy.
This study will examine a preventive strategy, the potential mechanism of bone loss, the ability of biochemical markers to predict bone mass, and skeletal outcomes when antiresorptive therapy is withdrawn.
Study Type
Interventional
Enrollment
112
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213-3221
- Osteoporosis Prevention & Treatment Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Men age 50-85
- Stage D0 prostate cancer
- On androgen deprivation therapy
Exclusion Criteria:
- Renal failure
- Hyperthyroidism
- Cushing's syndrome
- Metabolic bone disease
- Use of glucocorticoids
- Use of certain anticonvulsants
- On osteoporosis therapies
- Nonprostate cancers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
PA spine BMD over 1 year
|
Change in PA spine BMD over 2nd year
|
Secondary Outcome Measures
Outcome Measure |
---|
BMD at the hip and lateral spine
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Susan L. Greenspan, MD, University of Pittsburgh
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2002
Study Completion (Actual)
December 1, 2005
Study Registration Dates
First Submitted
November 8, 2002
First Submitted That Met QC Criteria
November 12, 2002
First Posted (Estimate)
November 13, 2002
Study Record Updates
Last Update Posted (Estimate)
March 2, 2010
Last Update Submitted That Met QC Criteria
March 1, 2010
Last Verified
March 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Gonadal Disorders
- Genital Neoplasms, Male
- Prostatic Diseases
- Musculoskeletal Diseases
- Bone Diseases
- Bone Diseases, Metabolic
- Prostatic Neoplasms
- Osteoporosis
- Hypogonadism
- Physiological Effects of Drugs
- Bone Density Conservation Agents
- Alendronate
Other Study ID Numbers
- DK61535 (completed)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prostate Cancer
-
Roswell Park Cancer InstituteRecruitingObesity | Overweight | Cancer Survivor | Prostate Adenocarcinoma | Stage I Prostate Cancer | Stage II Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage A Prostate Cancer | Stage... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Regeneron Pharmaceuticals; Prostate Cancer FoundationWithdrawnStage III Prostate Cancer | Stage IV Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage IIIA Prostate Cancer | Stage IIIB Prostate Cancer | Stage IIIC Prostate Cancer
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ryan Kohlbrenner, MDRadiological Society of North AmericaCompletedProstate Adenocarcinoma | Stage IV Prostate Cancer AJCC v8 | Prostate Carcinoma | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage...United States
-
Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.TerminatedRandomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer (PSMA-dRT)Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate Cancer AJCC v8 | Stage I Prostate...United States
-
University of Southern CaliforniaNational Cancer Institute (NCI); SanofiTerminatedDiarrhea | Recurrent Prostate Cancer | Hormone-resistant Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ohio State University Comprehensive Cancer CenterRiverside Methodist HospitalCompletedStage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnStage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate...United States
-
University of California, IrvineCompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Barbara Ann Karmanos Cancer InstituteGenentech, Inc.CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
Clinical Trials on alendronate
-
University of California, DavisNational Heart, Lung, and Blood Institute (NHLBI); Doris Duke Charitable FoundationNot yet recruitingOsteonecrosis | Avascular Necrosis | Sickle Cell Disease | Sickle Cell Anemia | Ischemic Necrosis
-
Aarhus University HospitalCompleted
-
Shanghai JMT-Bio Inc.Not yet recruitingGlucocorticoid Induced OsteoporosisChina
-
Göteborg UniversityCompletedOsteoporosis | Ankylosing SpondylitisSweden
-
National Taiwan University HospitalCompletedOsteoporosis | End-Stage Renal Disease
-
Chinese University of Hong KongRecruitingACL ReconstructionHong Kong
-
Aarhus University HospitalUniversity of AarhusCompleted
-
National Institute of Dental and Craniofacial Research...CompletedPolyostotic Fibrous DysplasiaUnited States
-
Ciudad Universitaria, SpainCompleted
-
Radius Health, Inc.CompletedPostmenopausal OsteoporosisPoland, Hong Kong, Romania, Estonia, United States, Argentina, Brazil, Denmark, Lithuania, Czechia