Actively Recruiting
A Feasibility Study of Oral Alendronate as Treatment for Osteonecrosis in Adults With Sickle Cell Disease
Led by University of California, Davis · Updated on 2026-04-13
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of California, Davis
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of oral alendronate in adults who have sickle cell disease (SCD) along with osteonecrosis of the hip and/or shoulder. This phase 2, single-arm, open-label study aims to assess the safety, tolerability, and preliminary effectiveness of alendronate over a 6-month period. The study also investigates changes in bone health markers and quality of life related to pain in this population. Participants will receive oral alendronate 70 mg once a week for 24 weeks (6 months). This study involves one treatment group where all enrolled adults with SCD and osteonecrosis receive the study drug. Bone biomarkers will be collected from blood and urine samples at baseline, 3 months, and 6 months to monitor biological changes. During the study, participants will be monitored for recruitment and retention rates, treatment-emergent adverse events, and changes in pain impact using the Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me) questionnaire, assessed up to 28 weeks. The trial includes safety checks and collection of laboratory data at specific time points, with a goal to complete data analysis by May 2026. The total study duration for participants is approximately 6 months.
CONDITIONS
Brief Title
Alendronate for Osteonecrosis in Adults With Sickle Cell Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years with sickle cell disease confirmed by hemoglobin electrophoresis or high performance liquid chromatography
- Ability to provide written informed consent
- Ability to lie on a dual-energy X-ray absorptiometry (DXA) scanner
- Negative urine pregnancy test for anyone of childbearing potential at study entry
You will not qualify if you...
- Pregnant women
- Adults unable to provide consent
- Individuals under 18 years old (infants, children, teenagers)
- Prisoners
- Hospitalization for any cause within 2 weeks prior to study entry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants take oral alendronate 70 mg once a week for 24 weeks (6 months) to treat osteonecrosis related to sickle cell disease. Safety, tolerability, pain impact, and bone biomarkers are monitored during this time.
Visits at baseline, 3 months, and 6 months for assessments and specimen collection
Trial Site Locations
Total: 1 location
1
UC Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
Research Team
L
Leyla Y Teos, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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