Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2026-04-22 @ 8:21 AM
Study NCT ID:
NCT05266261
Status:
COMPLETED
Last Update Posted:
2022-03-04
First Post:
2022-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Ibandronate in Diabetic Patients
Sponsor:
Yeouido St. Mary's Hospital
Organization:
Study Overview
Official Title:
Efficacy of Bisphosphonate Therapy on Postmenopausal Osteoporotic Women With and Without Diabetes: a Prospective Trial
Status:
COMPLETED
Status Verified Date:
2022-02
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 examine whether monthly oral administration of ibandronate to postmenopausal osteoporosis patients with type 2 diabetes differs in safety and efficacy compared to patients without diabetes.
Detailed Description:
There are two major considerations in the use of bisphosphonates in diabetic patients.
* The low rate of bone turnover in diabetic patients is at risk of side effects such as excessive inhibition of bone turnover associated with the use of bisphosphonates.
* A decrease in osteocalcin following bisphosphonate use may lead to deterioration of glucose metabolism.
The efficacy of ibandronate in T2DM is not thought to be significantly different based on previous studies, but there is few study on ibandronate.
* The low rate of bone turnover in diabetic patients is at risk of side effects such as excessive inhibition of bone turnover associated with the use of bisphosphonates.
* A decrease in osteocalcin following bisphosphonate use may lead to deterioration of glucose metabolism.
The efficacy of ibandronate in T2DM is not thought to be significantly different based on previous studies, but there is few study on ibandronate.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: