Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00361595
Status:
COMPLETED
Last Update Posted:
2017-04-21
First Post:
2006-08-04
Brief Title:
Intervenous IV Zoledronic Acid After Forteo in Postmenopausal Women
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Open Label Proof of Concept Study of IV Zoledronic Acid ZA 5 mg After Forteo in Postmenopausal Women
Status:
COMPLETED
Status Verified Date:
2017-03
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:
The purpose of this study is to evaluate the adequacy of zoledronic acid in maintaining bone mass after two years of treatment with Forteo in postmenopausal women
Detailed Description:
This will be a single center open label proof of concept study recruiting subjects previously treated with Forteo for at least 12 months
A screening period of 3 to 6 weeks will precede the treatment period At the baseline visit patients whose eligibility is confirmed will be treated with ZA and followed for 12 months Safety and efficacy will be assessed at regular intervals day one day 10 month 2 month 6 month 9 and month 12 Renal safety will be assessed prior to the iv dose of study medication day 10 after the iv dose of study medication and at 12 months Bone density at the lumbar spine L1-4 and total hip will be performed at 6 months and at the end of the 12 month treatment period Biomarker analyses for secondary endpoint will be performed for at day 10 month 2 month 6 month 9 and month 12
A screening period of 3 to 6 weeks will precede the treatment period At the baseline visit patients whose eligibility is confirmed will be treated with ZA and followed for 12 months Safety and efficacy will be assessed at regular intervals day one day 10 month 2 month 6 month 9 and month 12 Renal safety will be assessed prior to the iv dose of study medication day 10 after the iv dose of study medication and at 12 months Bone density at the lumbar spine L1-4 and total hip will be performed at 6 months and at the end of the 12 month treatment period Biomarker analyses for secondary endpoint will be performed for at day 10 month 2 month 6 month 9 and month 12
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