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
Status | Not yet recruiting |
Enrollment | 24 |
Est. completion date | July 2025 |
Est. primary completion date | February 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis | Doris Duke Charitable Foundation, National Heart, Lung, and Blood Institute (NHLBI) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recruitment and retention rates | Proportion of eligible patients who get recruited to the study; number of enrolled patients who complete 6-month study | up to 28 weeks | |
Primary | Incidence of Treatment-Emergent Adverse Events as assessed by participant report | Collect all adverse events reported by patients and determine if related to study drug | up to 28 weeks | |
Primary | Pain assessed by the Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me) Pain Impact questionnaire | The Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me) Pain Impact questionnaire is a patient-reported outcome measure of pain level in the past 7 days. The ASCQ-Me pain scale ranges from 0-100, with a standardized mean of 50 and a standard deviation of 10, where lower scores signify worse disease impact. | up to 28 weeks | |
Secondary | Serum CTX-1 | Measurement of C-terminal telopeptide of type I collagen (CTX) in serum as a biomarker for osteoclast activity (bone resorption) | baseline, 3 months, 6 months | |
Secondary | Serum P1NP | Measurement of Procollagen type I N-terminal propeptide (P1NP) in serum as a biomarker for osteoblast activity (bone formation) | baseline, 3 months, 6 months |
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