Using alendronate to treat osteonecrosis in adults with sickle cell disease
A Feasibility Study of Alendronate as Treatment for Osteonecrosis in Adults With Sickle Cell Disease
This study is testing if a weekly medication called alendronate can help adults with sickle cell disease who have bone pain from osteonecrosis feel better and improve their bone health.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT06016634 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the safety and preliminary efficacy of oral alendronate in adults with sickle cell disease (SCD) who have osteonecrosis. Participants will receive a weekly dose of alendronate for 24 weeks, and their pain levels and bone health will be monitored through various assessments, including the ASCQ-Me Pain Impact scores and bone biomarkers. The study will recruit 24 adults from the University of California Davis Medical Center, with the goal of understanding how well they tolerate the medication and any improvements in their condition over time.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with confirmed sickle cell disease and osteonecrosis.
Not a fit: Patients who are pregnant, unable to consent, or have had recent hospitalizations may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve pain management and quality of life for patients with sickle cell disease and osteonecrosis.
How similar studies have performed: While this approach is novel in the context of sickle cell disease, similar studies have explored the use of alendronate for other conditions with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-80 years with SCD (any genotype, confirmed by hemoglobin electrophoresis or high performance liquid chromatography) * Ability to provide written informed consent * Ability to lay on a dual-energy X-ray absorptiometry (DXA) scanner * Negative urine pregnancy test for anyone of childbearing potential at study entry Exclusion Criteria: * Pregnant women * Adults unable to consent * Individuals who are not yet adults (infants, children, teenagers) * Prisoners * Hospitalizations (for any cause) within 2 weeks of study entry
Where this trial is running
Sacramento, California
- UC Davis Comprehensive Cancer Center — Sacramento, California, United States (Recruiting)
Study contacts
- Principal investigator: Oyebimpe O Adesina, MD, MS — UC Davis School of Medicine
- Study coordinator: Leyla Y Teos, PhD
- Email: lyteos@ucdavis.edu
- Phone: (916) 460-2749
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.