A Feasibility Study of Alendronate as Treatment for Osteonecrosis in Adults With Sickle Cell Disease
University of California, Davis
Summary
A prospective, single-arm, intervention study of oral alendronate in adults with sickle cell disease and osteonecrosis
Description
The investigators hypothesize that adults with sickle cell disease (SCD) and osteonecrosis of the femoral (hip) and/or 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…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DrugAlendronate Sodium
Administer oral alendronate 70 mg once a week x 24 weeks to all study participants
Location
- UC Davis Comprehensive Cancer CenterSacramento, California