Sickle Cell Disease Clinical Trial
Official title:
A Feasibility Study of Alendronate as Treatment for Osteonecrosis in Adults With Sickle Cell Disease
A prospective, single-arm, intervention study of oral alendronate in adults with sickle cell disease and osteonecrosis
The investigators hypothesize that adults with sickle cell disease (SCD) and osteonecrosis in the hip or shoulder joint(s) will tolerate oral alendronate 70 mg administered once a week for 24 weeks (6 months). In addition to collecting safety and tolerability data of alendronate in study participants, the investigators will measure how alendronate therapy impacts quality of life measures using the Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me) questionnaires from baseline to 3-months and 6-months in study participants. 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 Mar 2024- Feb 2025. The study endpoints are summarized below: - To determine the recruitment and retention rates of adults with SCD-related ONFH 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 ONFH 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 July 2025. ;
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