Alendronate for Osteonecrosis in Adults With Sickle Cell Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of California, Davis
About this trial
A prospective, single-arm, intervention study of oral alendronate in adults with sickle cell disease and osteonecrosis
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Pregnant women
Adults unable to consent
Individuals who are not yet adults (infants, children, teenagers)
Prisoners
Trial design
Design model
Single group
Treatments tested in this trial
Alendronate Sodium
DrugAdminister oral alendronate 70 mg once a week x 24 weeks to all study participants
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Alendronate groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment and retention rates
Proportion of eligible patients who get recruited to the study; number of enrolled patients who complete 6-month study
Time frame
up to 28 weeks2
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
Time frame
up to 28 weeks3
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.
Time frame
up to 28 weeksSecondary outcomes
1
Bone turnover markers
Measure longitudinal changes in of biomarkers for osteoclast (bone resorption) and osteoblast (bone formation) activity
Time frame
Baseline, then every 2 months until end of study2
Inflammatory biomarkers
Measure longitudinal changes in inflammatory biomarkers from baseline to the end of the study
Time frame
Baseline, then every 2 months until the end of the study3
Vascular adhesion biomarkers
Measure longitudinal changes in biomarkers of vascular adhesion from baseline until the end of the study
Time frame
Baseline, then every 2 months until the end of the studySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Davis
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Doris Duke Charitable Foundation
Collaborator
Source ClinicalTrials.gov