Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06016634
Status:
RECRUITING
Last Update Posted:
2024-02-22
First Post:
2023-08-07
Brief Title:
Alendronate for Osteonecrosis in Adults With Sickle Cell Disease
Sponsor:
University of California Davis
Organization:
University of California Davis
Study Overview
Official Title:
A Feasibility Study of Alendronate as Treatment for Osteonecrosis in Adults With Sickle Cell Disease
Status:
RECRUITING
Status Verified Date:
2024-07
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:
A prospective single-arm intervention study of oral alendronate in adults with sickle cell disease and osteonecrosis
Detailed Description:
The investigators hypothesize that adults with sickle cell disease SCD and osteonecrosis of the femoral hip andor humeral shoulder heads will tolerate oral alendronate 70 mg administered once a week x 24 weeks 6 months In addition to collecting safety and tolerability data on alendronate in study participants the investigators will also measure the preliminary efficacy of alendronate using changes in the Adult Sickle Cell Quality of Life Measurement System ASCQ-Me Pain Impact scores from baseline to 3-months and 6-months after alendronate initiation Serum and urine specimen will also be collected to assess changes in bone biomarkers at baseline 3-months and 6-months
The investigators plan to recruit 24 adults with SCD from the University of California Davis Medical Center to this single-arm open label interventional study The investigators anticipate enrolling 1-2 participants per month between Sep 2024- Dec 2025
The study endpoints are summarized below
To determine the recruitment and retention rates of adults with SCD and osteonecrosis enrolled in this prospective single-arm open label alendronate interventional study
To measure the safety tolerability and preliminary efficacy of oral alendronate in adults with SCD-related osteonecrosis over a 6-month treatment duration
To measure changes in bone biomarkers in the serum and urine of study participants not receiving chronic red blood cell transfusions at 3 time points baseline 3-months and 6-months after initiation of alendronate
The investigators goal is to complete primary data analysis by May 2026
The investigators plan to recruit 24 adults with SCD from the University of California Davis Medical Center to this single-arm open label interventional study The investigators anticipate enrolling 1-2 participants per month between Sep 2024- Dec 2025
The study endpoints are summarized below
To determine the recruitment and retention rates of adults with SCD and osteonecrosis enrolled in this prospective single-arm open label alendronate interventional study
To measure the safety tolerability and preliminary efficacy of oral alendronate in adults with SCD-related osteonecrosis over a 6-month treatment duration
To measure changes in bone biomarkers in the serum and urine of study participants not receiving chronic red blood cell transfusions at 3 time points baseline 3-months and 6-months after initiation of alendronate
The investigators goal is to complete primary data analysis by May 2026
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5K23HL148310 | NIH | None | None |
| 2020095 | OTHER_GRANT | Doris Duke Charitable Foundation | httpsreporternihgovquickSearch5K23HL148310 |