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, 2003

Actual 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.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesGenital Diseases, MaleGenital Neoplasms, MaleNeoplasmsNeoplasms by SiteProstatic DiseasesProstatic NeoplasmsUrogenital NeoplasmsMale 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 Center

Tucson, United StatesSee the location
Suspended

VA Medical Center - Long Beach

Long Beach, United States
Suspended

Washington VA Medical Center

Washington, United States
Suspended

Veterans Affairs Medical Center

Augusta, United States
Completed16 Study Centers