Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00035997
Status:
COMPLETED
Last Update Posted:
2009-11-23
First Post:
2002-05-07
Brief Title:
Open-label Trial on the Effect of IV Zoledronic Acid 4 mg on Bone Density in Hormone Sensitive Prostate Cancer Patients With Bone Metastasis
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
An Open-label Trial on the Effect of IV Zoledronic Acid 4 mg on Bone Mineral Density in Hormone Sensitive Prostate Cancer Patients With Bone Metastasis
Status:
COMPLETED
Status Verified Date:
2009-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this trial with Zometa is to investigate the effect ZOMETA 4 mg zoledronic acid for injection in 100mg solution has in preventing associated bone loss in prostate cancer patients with bone metastasis when administered in conjunction with hormonal cancer therapy This trial will seek to determine the effect of ZOMETA in stabilizing and increasing bone mineral density in these patients
This prospective open-label single arm multicenter study will enroll approximately 200 prostate cancer patients with a history of at least one documented bone lesion documented by bone scan or radiograph Patients must already be receiving hormone therapy and meet the following additional criteria
18 years of age or older
Histologically confirmed diagnoses of prostate cancer
Confirmed objective evidence of metastatic bone disease as evidenced by bone scan or radiograph
Received or will receive hormonal treatment also know as androgen deprivation therapy with an LHRH agonist or other hormonal treatments
Throughout the course of this 12-month trial patients will be identified based on the duration of established hormonal treatment at the time of enrollment Each patients duration of participation will be up to 56 weeks including a 4 week screening 48 week treatment and a 4 week follow up
This prospective open-label single arm multicenter study will enroll approximately 200 prostate cancer patients with a history of at least one documented bone lesion documented by bone scan or radiograph Patients must already be receiving hormone therapy and meet the following additional criteria
18 years of age or older
Histologically confirmed diagnoses of prostate cancer
Confirmed objective evidence of metastatic bone disease as evidenced by bone scan or radiograph
Received or will receive hormonal treatment also know as androgen deprivation therapy with an LHRH agonist or other hormonal treatments
Throughout the course of this 12-month trial patients will be identified based on the duration of established hormonal treatment at the time of enrollment Each patients duration of participation will be up to 56 weeks including a 4 week screening 48 week treatment and a 4 week follow up
Detailed Description:
None
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 |
|---|---|---|---|
| US24 | None | None | None |