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Study of Weekly Oral Alendronate for Treating Osteonecrosis in Adults with Sickle Cell Disease
Led by University of California, Davis · Updated on 2026-07-16
30
Participants Needed
1
Research Sites
13 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the use of oral alendronate in adults aged 18 to 80 years who have sickle cell disease SCD and osteonecrosis affecting the hip or shoulder bones. This phase 2, single-arm, open-label study aims to assess safety, tolerability, and preliminary effectiveness by measuring pain impact and bone biomarker changes during treatment. The study plans to recruit 24 adults with SCD from a medical center between 2024 and 2025. Participants will take oral alendronate 70 mg once a week for 24 weeks 6 months. Bone biomarkers will be measured through serum and urine samples at the start, 3 months, and 6 months after starting the medication. The study will also track recruitment and retention rates and monitor adverse events throughout the 28-week period. During the study, participants will complete the Adult Sickle Cell Quality of Life Measurement System ASCQ-Me Pain Impact questionnaire at baseline, 3 months, and 6 months. Researchers will collect blood and urine samples every two months to assess bone turnover, inflammatory, and vascular adhesion biomarkers. Safety and tolerability will be monitored through participant reports. The study expects to complete its primary data analysis by May 2026.
CONDITIONS
Brief Title
Alendronate for Osteonecrosis in Adults With Sickle Cell Disease
Research Team
L
Leyla Y Teos, PhD
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