Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216060
Status:
TERMINATED
Last Update Posted:
2016-05-26
First Post:
2005-09-13
Brief Title:
Risedronate to Prevent Skeletal Related Events in Patients With Metastatic Prostate Cancer Commencing Hormonal Therapy
Sponsor:
Christopher Sweeney MBBS
Organization:
Hoosier Cancer Research Network
Study Overview
Official Title:
A Phase III Randomized Double-Blind Placebo-Controlled Trial Evaluating the Ability of Risedronate to Prevent Skeletal Related Events in Patients With Metastatic Prostate Cancer Commencing Hormonal Therapy Hoosier Oncology Group GU02-41
Status:
TERMINATED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Risedronate is an orally administered pyridinyl bisphosphonate that is 36 times more potent than pamidronate and 72 times more potent than clodronate Four randomized double-blind trials have been carried out in patients with postmenopausal osteoporosis In 2 of these studies vertebral fracture incidence was reduced by a daily dose of 5 mg risedronate by up to 65 and 49 relative to placebo after 1 and 3 years respectively In these trials risedronate improved lumbar spine femoral neck and femoral trochanter bone mineral density BMD at 6 months In addition preclinical studies have shown that risedronate is more potent than pamidronate and clodronate in inhibiting adhesion of prostate cancer cells to bone and preventing tumor cell invasion The incidence of osteoporosis in prostate cancer patients has been well established therefore it is advantageous to assess the efficacy of oral bisphosphonate therapy
Detailed Description:
OUTLINE This is a randomized placebo-controlled double-blind multicenter 2 arm study
The study population will consist of prostate cancer patients with metastatic bone disease for whom androgen-deprivation therapy is planned After stratification based on the patients age performance status and severity of metastatic disease the patients will be randomized at a 11 ratio to the following treatment arms
Daily oral risedronate combined with androgen deprivation
Daily oral placebo combined with androgen deprivation
Initial clinical evaluation will be performed during the 2-week screening period While patients receive per-protocol treatment study assessments will be performed every 4 weeks during the first 3 months and every 12 weeks thereafter
Performance Status Eastern Cooperative Oncology Group ECOG 0 to 2
Life Expectancy At least 12 weeks
Hematopoietic
Absolute neutrophil count ANC 1000mm3
Platelet count 100000mm3
international normalized ratio INR 15 x upper limit of normal unless on therapeutic anticoagulation
Partial thromboplastin time PTT 15 x upper limit of normal unless on therapeutic anticoagulation
Hepatic
Bilirubin 15 mgdL
Alanine transaminase ALT 25 x upper limit of normal
Renal
Creatinine clearance of 30 mLmin by Cockcroft-Gault
Cardiovascular
No significant history of uncontrolled cardiac disease ie uncontrolled hypertension unstable angina and congestive heart failure
Pulmonary
Not specified
Calcium
Corrected serum calcium 40 gdL - actual albumin gdLx 08 serum calcium
The study population will consist of prostate cancer patients with metastatic bone disease for whom androgen-deprivation therapy is planned After stratification based on the patients age performance status and severity of metastatic disease the patients will be randomized at a 11 ratio to the following treatment arms
Daily oral risedronate combined with androgen deprivation
Daily oral placebo combined with androgen deprivation
Initial clinical evaluation will be performed during the 2-week screening period While patients receive per-protocol treatment study assessments will be performed every 4 weeks during the first 3 months and every 12 weeks thereafter
Performance Status Eastern Cooperative Oncology Group ECOG 0 to 2
Life Expectancy At least 12 weeks
Hematopoietic
Absolute neutrophil count ANC 1000mm3
Platelet count 100000mm3
international normalized ratio INR 15 x upper limit of normal unless on therapeutic anticoagulation
Partial thromboplastin time PTT 15 x upper limit of normal unless on therapeutic anticoagulation
Hepatic
Bilirubin 15 mgdL
Alanine transaminase ALT 25 x upper limit of normal
Renal
Creatinine clearance of 30 mLmin by Cockcroft-Gault
Cardiovascular
No significant history of uncontrolled cardiac disease ie uncontrolled hypertension unstable angina and congestive heart failure
Pulmonary
Not specified
Calcium
Corrected serum calcium 40 gdL - actual albumin gdLx 08 serum calcium
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None