Ignite Creation Date:
2024-05-06 @ 5:42 PM
Last Modification Date:
2024-10-26 @ 2:34 PM
Study NCT ID:
NCT05405894
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-14
First Post:
2022-05-27
Brief Title:
Efficacy of Zoledronic Acid to Prevent Bone Loss Following Denosumab Discontinuation
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
Efficacy of a Single Infusion of Zoledronic Acid to Mitigate the Rebound Effect of Rapid Bone Loss Following Denosumab Treatment Discontinuation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
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 two-year observational open-label clinical trial will evaluate the efficacy of a once-yearly infusion of zoledronic acid after denosumab discontinuation to maintain tissue mineral density and bone microarchitecture using high-resolution peripheral quantitative computed tomography HR-pQCT among post-menopausal women with osteoporosis
Detailed Description:
As part of an observational study twenty female osteoporosis patients looking to transition off denosumab therapy will be recruited from the David Hanley Osteoporosis Centre and affiliated primary care physicians in Calgary The decision to stop denosumab will be made in accordance with standard clinical care and fully separate from the present study Approximately 6-8 months after the patients final denosumab injection patients will receive a single infusion of zoledronic acid 5 mg100mL as part of their routine standard of care The 6-8 month time frame corresponds with the recommended duration between subsequent denosumab injections Concurrent with zoledronic acid treatment within one month before or after infusion patients will visit to the McCaig Institute for Bone and Joint Health to receive a baseline dual X-ray absorptiometry scan lumbar spine lateral vertebral assessment and hip and a high-resolution peripheral computed tomography scan radius and tibia to quantify areal BMD and volumetric BMDbone microarchitecture respectively They will also complete the MoJo Fracture Risk Questionnaire Patients will return for repeat scanning and questionnaire administrations to monitor potential changes to bone at 6 and 12 months after baseline Any fracture events during the 12-month time frame will be logged in consultation with the patients physician as documented through routine clinical follow-up Researchers may contact participants to repeat scanning and questionnaire administration at the 24-month time point if participants agree to this contact within the informed consent
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?:
False
Is an FDA AA801 Violation?:
None