Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00399802
Status:
COMPLETED
Last Update Posted:
2018-08-16
First Post:
2006-11-14
Brief Title:
A Study to Examine the Effects of an Experimental Drug on Women With Breast Cancer and Metastatic Bone Disease MBD0822-016COMPLETED
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase II Study to Assess the Safety Tolerability and Efficacy of MK-0822 Cathepsin-K Inhibitor in the Treatment of Women With Breast Cancer and Established Bone Metastases MBD
Status:
COMPLETED
Status Verified Date:
2018-07
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:
This is a 4-week study to examine the effects of a new experimental medication on women with breast cancer and established bone metastases This study will enroll approximately 45 women The primary hypotheses are 1 odanacatib will result in a substantial suppression of urinary N-telopeptide of type I collagen u-NTx similar to that achieved with an intravenous IV infusion of zoledronic acid ZA over 4 weeks of treatment and 2 odanacatib MK-0822 will be safe and well tolerated during 4 weeks of treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| MK-0822-016 | OTHER | Merck Protocol Number | None |
| 2006_533 | OTHER | None | None |