Efficacy Study of Risedronate to Prevent Cancer Treatment-Induced Bone Loss in Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
Prostate cancer patients treated with LHRH agonists (e.g., leuprolide) lose bone mineral density. This is similar to post-menopausal osteoporosis. Risedronate is approved to prevent osteoporosis. We hypothesize that risedronate may also be effective in prostate cancer patients treated with LHRH agonists.

Detailed Description
-----------------
IV bisphosphonates have proven effective in treating bone loss in prostate cancer patients treated with LHRH agonists. However, it is yet to be determined if an oral bisphosphonate such as risedronate could offer the same benefits.

Official Title
-----------------
A Randomized, Single-blind, Placebo-controlled, Multicentre Study to Evaluate the Effect of Risedronate and Placebo on Bone Mineral Density in Men Undergoing Androgen Deprivation Therapy With Leuprolide Acetate

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: risedronate
* Drug: risedronate
* Drug: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years of age. Histologically confirmed diagnosis of prostate cancer without metastases. Patient must have negative bone scan to rule out bone metastases. Patient for whom androgen deprivation therapy with leuprolide acetate is indicated for at least 1 year. Eastern Cooperative Oncology Group (ECOG) score of 0 - 2. Study medication must be started within 3 months of initiation of ADT. Signed written informed consent. Exclusion Criteria: Prior ADT (greater than 3 months). History of treatment with calcitriol or bisphosphonates. Suppressive doses of thyroxine within the previous year. Concomitant or prior history of long-term treatment (greater than or equal to 3 months) with systemic glucocorticoids. Evidence of any of the following conditions per subject self-report or chart review: Current hyper- or hypothyroidism (stable on thyroid replacement therapy is allowed, if TSH is within normal reference range). Paget's disease, Cushing's disease, hyperprolactinemia, chronic liver disease. Unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before randomization. Major surgery or significant traumatic injury occurring within 1 month prior to randomization. Known hypersensitivity to leuprolide acetate or any of the components found in Eligard Any concurrent condition that would make it undesirable, in the physician's opinion, for the subject to participate in the study or would jeopardize compliance with the protocol.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: risedronate<br> | Drug: risedronate<br>* risedronate 35mg tablet, weekly for 12 months<br>* Other names: Actonel;Drug: risedronate<br>* 35mg weekly<br>* Other names: Actonel;|
| Placebo Comparator: placebo<br> | Drug: Control<br>* risedronate-matched placebo weekly<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone mineral density of the lumbar spine |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall safety |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate cancer, prostatic adenoma, prostatic neoplasm