Completed

A Prostate Cancer Study in Men Undergoing Androgen Deprivation Therapy

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Data Collection

Who is being recruted

Urogenital Diseases
+7

+ Genital Diseases
+ Genital Diseases, Male
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: December 2003
See protocol details

Summary

Principal SponsorNovartis Pharmaceuticals
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2003Actual date on which the first participant was enrolled.

This study is being conducted to compare the effect of an investigational drug versus placebo on bone loss in men with prostate cancer who are receiving Androgen Deprivation Therapy (ADT). The study drug or placebo will be administered every three months of four treatments in one year. In order to participate, male patients 18 years and older must be consecutive veterans from participating Veterans Administration Medical Centers.

Official TitleA Prostate Cancer Study in Men Undergoing Androgen Deprivation Therapy 
NCT00087659
Principal SponsorNovartis Pharmaceuticals
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
MaleBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Urogenital Diseases
Genital Diseases
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Prostatic Neoplasms
Urogenital Neoplasms
Male Urogenital Diseases
Criteria

Inclusion Criteria: * Signed informed consent * Age \> 18 years * Histologically confirmed diagnosis of carcinoma of the prostate * No distant metastases at the start of ADT and continuously low PSA (\<2.0) on continuous ADT (stage Tany Nany MO). * Patients initiating or receiving ADT with a LHRH agonist (with or without an antiandrogen) and with the intended duration of ADT of at least 12 months at the time of randomization. Patients undergoing bilateral orchiectomy or with history of this procedure are also eligible. * Patient with a baseline BMD T-score at or above -2.0 standard deviations in the lumbar spine (L2-L4) and the total hip are eligible * Life expectancy of at least 12 months * Zubrod performance status of 0, 1, or 2 Exclusion Criteria: * Patients who received any prior bisphosphonate therapy in the past 6 months * Metabolic bone disease including Paget's disease or hyperparathyroidism * Radiographic evidence of bone metastases * Patients who have received prior treatment with systemic corticosteroids within the past 12 months (short term corticosteroid therapy, e.g. to prevent/treat chemotherapy-induced nausea/vomiting or for acute illness like asthma exacerbation, is acceptable) * Patients with prior exposure to anabolic steroids or growth hormone within the past 6 months * Current treatment with estrogen or complementary medicines known to contain estrogens * Patients with clinical or radiological evidence of existing fracture in the lumbar spine and/or total hip * Patients with a history of fracture with low-intensity or no associated trauma * Patients with any prior treatment for osteoporosis * Patients with previous or concomitant malignancy within the past 5 years except adequately treated basal or squamous cell carcinoma of the skin, and colonic polyps with non-invasive malignancy which have been removed * Patients with nonmalignant conditions which would confound the evaluation of the primary endpoint, impair tolerance of therapy, or prevent compliance to the protocol, including: * uncontrolled infections * uncontrolled type 2 diabetes mellitus * diseases with influence on bone metabolism, such as Paget's disease or uncontrolled thyroid or parathyroid dysfunction * cardiovascular, renal, hepatic, pulmonary and neurologic/psychiatric diseases which would prevent prolonged follow-up * History of surgery at the lumbosacral spine, with or without implantable devices, bilateral hip replacement or bilateral hip surgery with implantation of an appliance * Patients treated with systemic investigational drugs(s) and /or device(s) within the past 30 days * Patients with abnormal renal function as evidenced by either a serum creatinine greater than 3 mg/dL or by a calculated creatinine clearance of 60 ml/minute or less * Corrected (adjusted for serum albumin) serum calcium concentration \< 8.0 mg/dl (2.00 mmol/L) * Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 16 locations
Suspended
Tucson VA Medical CenterTucson, United StatesSee the location
Suspended
VA Medical Center - Long BeachLong Beach, United States
Suspended
Washington VA Medical CenterWashington, United States
Suspended
Veterans Affairs Medical CenterAugusta, United States

Completed16 Study Centers
;