Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00329797
Status:
COMPLETED
Last Update Posted:
2017-11-29
First Post:
2006-05-23
Brief Title:
Zoledronate in Preventing Osteoporosis and Bone Fractures in Patients With Locally Advanced Nonmetastatic Prostate Cancer Undergoing Radiation Therapy and Hormone Therapy
Sponsor:
Radiation Therapy Oncology Group
Organization:
Radiation Therapy Oncology Group
Study Overview
Official Title:
A Phase III Randomized Study to Evaluate the Efficacy of Zometa for the Prevention of Osteoporosis and Associated Fractures in Patients Receiving Radiation Therapy and Long Term LHRH Agonists for High-Grade andor Locally Advanced Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Zoledronate may prevent bone loss in patients with prostate cancer undergoing radiation therapy and hormone therapy It is not yet known whether zoledronate is more effective than calcium and vitamin D alone in preventing osteoporosis and bone fractures in patients with prostate cancer
PURPOSE This randomized phase III trial is studying zoledronate to see how well it works compared to calcium and vitamin D alone in preventing osteoporosis and bone fractures in patients with locally advanced nonmetastatic prostate cancer undergoing radiation therapy and hormone therapy
PURPOSE This randomized phase III trial is studying zoledronate to see how well it works compared to calcium and vitamin D alone in preventing osteoporosis and bone fractures in patients with locally advanced nonmetastatic prostate cancer undergoing radiation therapy and hormone therapy
Detailed Description:
OBJECTIVES
Primary
Compare the potential benefit of bisphosphonate therapy comprising zoledronate plus vitamin D and calcium supplement vs standard therapy with vitamin D and calcium supplement in the prevention of osteoporosis and associated bone fractures in patients with locally advanced nonmetastatic adenocarcinoma of the prostate undergoing radiotherapy and luteinizing hormone-releasing hormone LHRH agonist therapy
Secondary
Evaluate the potential benefit of these regimens on quality of life in these patients
Evaluate the potential benefit in bone mineral density over a period of 3 years for patients treated with these regimens
OUTLINE This is randomized multicenter study Patients are stratified according to T score of the hip by dual x-ray absorptiometry DXA scan -10 but -25 vs - 10 and planned duration of luteinizing hormone-releasing hormone LHRH agonist therapy 1-2½ years vs 2½ years Patients are randomized to 1 of 2 treatment arms
Quality of life is assessed at baseline and every 6 months during treatment
Primary
Compare the potential benefit of bisphosphonate therapy comprising zoledronate plus vitamin D and calcium supplement vs standard therapy with vitamin D and calcium supplement in the prevention of osteoporosis and associated bone fractures in patients with locally advanced nonmetastatic adenocarcinoma of the prostate undergoing radiotherapy and luteinizing hormone-releasing hormone LHRH agonist therapy
Secondary
Evaluate the potential benefit of these regimens on quality of life in these patients
Evaluate the potential benefit in bone mineral density over a period of 3 years for patients treated with these regimens
OUTLINE This is randomized multicenter study Patients are stratified according to T score of the hip by dual x-ray absorptiometry DXA scan -10 but -25 vs - 10 and planned duration of luteinizing hormone-releasing hormone LHRH agonist therapy 1-2½ years vs 2½ years Patients are randomized to 1 of 2 treatment arms
Quality of life is assessed at baseline and every 6 months during treatment
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2009-00884 | REGISTRY | CTRP Clinical Trial Reporting Program | None |
| CDR0000476469 | None | None | None |