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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00426777

Enrollment

160

Registered

2007-01-25

Start date

2007-01-31

Completion date

2009-02-28

Last updated

2012-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

prostate cancer, prostatic adenoma, prostatic neoplasm

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.

Interventions

DRUGrisedronate

risedronate 35mg tablet, weekly for 12 months

DRUGControl

risedronate-matched placebo weekly

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
bone mineral density of the lumbar spine	12 months

Secondary

Measure	Time frame
overall safety	12 months

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026