Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305695
Status:
COMPLETED
Last Update Posted:
2020-03-24
First Post:
2006-03-21
Brief Title:
Zoledronate or Observation in Maintaining Bone Mineral Density in Patients Who Are Undergoing Surgery to Remove Both Ovaries
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase II Randomized Study of the Effect of Zoledronic Acid Versus Observation on Bone Mineral Density of the Lumbar Spine in Women Who Elect to Undergo Surgery That Results in Removal of Both Ovaries
Status:
COMPLETED
Status Verified Date:
2020-03
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 randomized phase II trial is studying zoledronate to see how well it works compared to observation in maintaining bone mineral density in patients who are undergoing surgery to remove both ovaries Zoledronate may prevent bone loss in patients who are undergoing surgery to remove the ovaries
Detailed Description:
PRIMARY OBJECTIVE
I Compare the effect of zoledronate vs observation on bone loss associated with surgery at a minimum any surgical procedure that results in removal of both ovaries in patients undergoing excision of both ovaries
SECONDARY OBJECTIVE
I Compare the change in bone mineral density of the bilateral hip in patients treated with these regimens
TERTIARY OBJECTIVE
I Compare the effect of zoledronate vs observation on biochemical markers of bone resorption and bone formation N-telopeptide and bone specific alkaline phosphatase during 1 year of treatment
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
All patients undergo surgery with removal of both ovaries in month 1 All patients are requested to take calcium supplements twice daily and a multivitamin containing vitamin D once daily beginning in month 1 and continuing for up to 18 months
ARM I Beginning 60-90 days after surgery patients receive zoledronate IV over 15 minutes once in months 3 9 and 15
ARM II Patients are observed for 18 months after surgery
In both arms patients complete physical activity questionnaires at baseline and in months 3 9 15 and 18 Patients undergo bone mineral density test of lumbar spine and total hip at baseline and in months 9 and 18 Patients also undergo blood collection at baseline and periodically during the study for biomarker studies
I Compare the effect of zoledronate vs observation on bone loss associated with surgery at a minimum any surgical procedure that results in removal of both ovaries in patients undergoing excision of both ovaries
SECONDARY OBJECTIVE
I Compare the change in bone mineral density of the bilateral hip in patients treated with these regimens
TERTIARY OBJECTIVE
I Compare the effect of zoledronate vs observation on biochemical markers of bone resorption and bone formation N-telopeptide and bone specific alkaline phosphatase during 1 year of treatment
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
All patients undergo surgery with removal of both ovaries in month 1 All patients are requested to take calcium supplements twice daily and a multivitamin containing vitamin D once daily beginning in month 1 and continuing for up to 18 months
ARM I Beginning 60-90 days after surgery patients receive zoledronate IV over 15 minutes once in months 3 9 and 15
ARM II Patients are observed for 18 months after surgery
In both arms patients complete physical activity questionnaires at baseline and in months 3 9 15 and 18 Patients undergo bone mineral density test of lumbar spine and total hip at baseline and in months 9 and 18 Patients also undergo blood collection at baseline and periodically during the study for biomarker studies
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 |
|---|---|---|---|
| U10CA101165 | NIH | CTEP | httpsreporternihgovquickSearchU10CA101165 |
| NCI-2009-00589 | REGISTRY | None | None |
| NCI-P6966 | None | None | None |
| NOVARTIS-GOG-0215 | None | None | None |
| CDR0000462217 | None | None | None |
| NCI-06-C-0204 | None | None | None |
| GOG-0215 | OTHER | None | None |
| GOG-0215 | OTHER | None | None |
| GOG-0215 | OTHER | None | None |