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Sponsored by: |
GTx |
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Information provided by: | GTx |
ClinicalTrials.gov Identifier: | NCT00129142 |
Androgen deprivation therapy (ADT) treatment for prostate cancer decreases the natural hormone called testosterone. This type of therapy is very effective for the treatment of prostate cancer. However, one of the side effects is bone loss or thinning of the bones that can lead to osteoporosis and an increased risk of bone fractures (breaking of the bones). The purpose of the study is to determine whether or not the addition of toremifene citrate (the study drug) to therapy can prevent or decrease the number of bone fractures and to evaluate its impact on side effects associated with testosterone reduction therapy.
Condition | Intervention | Phase |
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Prostate Cancer Osteoporosis Fractures |
Drug: Toremifene Citrate |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double Blind, Placebo Controlled, Multicenter Efficacy and Safety Study of Toremifene Citrate for Prevention of Bone Fractures in Men With Prostate Cancer on Androgen Deprivation Therapy |
Estimated Enrollment: | 1200 |
Study Start Date: | October 2003 |
Study Completion Date: | November 2007 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
To be eligible for participation in this study, subjects must meet all of the following criteria (minor deviations may be discussed with the medical monitor for possible inclusions):
Have been on:
Be aged ≥ 70 years or have BMD of lumbar spine or femoral neck at or below the specified thresholds for study entry:
Have adequate bone marrow, liver and renal function:
Exclusion Criteria:
Subjects with any of the following will not be eligible for enrollment:
Study Director: | Robert S. Boger, M.D. | GTx |
Study ID Numbers: | G300203 |
Study First Received: | August 9, 2005 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00129142 |
Health Authority: | United States: Food and Drug Administration |
Prostate cancer Bone Loss Osteoporosis Fractures Androgen Deprivation Therapy |
Genital Neoplasms, Male Prostatic Diseases Citric Acid Fractures, Bone Wounds and Injuries Osteoporosis Disorders of Environmental Origin |
Bone Diseases, Metabolic Urogenital Neoplasms Genital Diseases, Male Bone Diseases Toremifene Musculoskeletal Diseases Prostatic Neoplasms |
Estrogen Receptor Modulators Neoplasms Neoplasms by Site Antineoplastic Agents, Hormonal Antineoplastic Agents Hormone Antagonists |
Therapeutic Uses Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Selective Estrogen Receptor Modulators Pharmacologic Actions |