NCT06016634 · University of California, Davis
Alendronate for Osteonecrosis in Adults With Sickle Cell Disease
What this study is about
A forward-looking, single-treatment group$1, intervention study of taken by mouth alendronate in adults with sickle cell disease and osteonecrosis
View original scientific description
A prospective, single-arm, intervention study of oral alendronate in adults with sickle cell disease and osteonecrosis
Interventions
DRUG
Alendronate Sodium
Administer oral alendronate 70 mg once a week x 24 weeks to all study participants
Primary outcome measures
Recruitment and retention rates
Time frame: up to 28 weeks
Proportion of eligible patients who get recruited to the study; number of enrolled patients who complete 6-month study
Incidence of Treatment-Emergent Adverse Events as assessed by participant report
Time frame: up to 28 weeks
Collect all adverse events reported by patients and determine if related to study drug
Pain assessed by the Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me) Pain Impact questionnaire
Time frame: up to 28 weeks
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
- Hospitalizations (for any cause) within 2 weeks of study entry
Where
- Sacramento, California
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Doris Duke Charitable Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 16, 2026 · Source of record for eligibility and locations