Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT04702204
Status:
COMPLETED
Last Update Posted:
2021-09-01
First Post:
2021-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Denosumab Treatment in Bisphosphonate Unresponsive Patients
Sponsor:
Nigde Omer Halisdemir University
Organization:
Study Overview
Official Title:
Efficacy and Safety of Denosumab Treatment in Bisphosphonate Unresponsive Postmenopausal Osteoporotic
Status:
COMPLETED
Status Verified Date:
2021-08
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 study, which was designed as a prospective observational study, was planned to enroll 75 female patients with postmenopausal osteoporosis who had been using bisphosphonates for more than two years and did not respond to treatment. 2 doses of denosumab were administered to the patients every 6 months. Bone mineral density of patients were measured with DEXA at the beginning and end of the study. A total of 66 patients completed the study.
At the end of the study, there was a significant improvement in the femur and lumbar total bone mineral density of the patients compared to the baseline. However, no statistically significant difference was found in terms of the frequency of new fractures.
At the end of the study, there was a significant improvement in the femur and lumbar total bone mineral density of the patients compared to the baseline. However, no statistically significant difference was found in terms of the frequency of new fractures.
Detailed Description:
None
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?:
True
Is an FDA AA801 Violation?: