Clinical trial NCT00426777: Efficacy Study of Risedronate to Prevent Cancer Treatment-Induced Bone Loss in Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: prostate cancer
prostatic adenoma
prostatic neoplasm
Lead sponsor: CMX Research
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2007-01-25
Enrollment: 160
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: bone mineral density of the lumbar spine
timeFrame: 12 months
Secondary outcomes:
measure: overall safety
timeFrame: 12 months
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: Southern Interior Medical Research Corporation
state: British Columbia
city: Surrey
country: Canada
facility: Dr. Cal Andreou
state: British Columbia
city: Fredericton
country: Canada
facility: Dr. Allan Patrick
state: New Brunswick
city: Barrie
country: Canada
facility: The Male/Female Health and Research Centre
state: Ontario
city: Brampton
country: Canada
facility: Dr. Stanley Flax
state: Ontario
city: Brantford
country: Canada
facility: Brantford Urology Research, Medical Arts Building
state: Ontario
city: Burlington
country: Canada
facility: G. Kenneth Jansz Medicine Professional Corporation
state: Ontario
city: Burlington
country: Canada
facility: Urology Research Centre
state: Ontario
city: Guelph
country: Canada
facility: Guelph Urology Associates
state: Ontario
city: Mississauga
country: Canada
facility: Credit Valley Medical Arts Centre
state: Ontario
city: Newmarket
country: Canada
facility: Mor Urology Inc., Bayview Business Centre
state: Ontario
city: Oakville
country: Canada
facility: The Male and Female Health Centre
state: Ontario
city: Orillia
country: Canada
facility: Orillia Urology Associates
state: Ontario
city: Oshawa
country: Canada
facility: Urotec
state: Ontario
city: Owen Sound
country: Canada
facility: Dr. Todd Webster
state: Ontario
city: Peterborough
country: Canada
facility: Kawartha Urology Associates
state: Ontario
city: Scarborough
country: Canada
facility: Dr. Allan Abramovitch
state: Ontario
city: Sudbury
country: Canada
facility: Northern Urology Centre
state: Ontario
city: Toronto
country: Canada
facility: The Male Health Centre
state: Ontario
city: Willowdale
country: Canada
facility: Dr. Roger J. Buckley
state: Ontario
city: Greenfield Park
country: Canada
facility: Urology South Shore Research
state: Quebec
Study officials:
affiliation: CMX Research
name: Richard W Casey, M.D.
role: PRINCIPAL_INVESTIGATOR
References: