Alendronate for Osteonecrosis in Adults With Sickle Cell Disease
NCT ID: NCT06016634
Last Updated: 2026-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2026-02-09
2027-12-31
Brief Summary
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Detailed Description
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The investigators plan to recruit 24 adults with SCD from the University of California Davis Medical Center to this single-arm, open label, interventional study. The investigators anticipate enrolling 1-2 participants per month between Sep 2024- Dec 2025.
The study endpoints are summarized below:
* To determine the recruitment and retention rates of adults with SCD and osteonecrosis enrolled in this prospective, single-arm, open label alendronate interventional study
* To measure the safety, tolerability, and preliminary efficacy of oral alendronate in adults with SCD-related osteonecrosis over a 6-month treatment duration
* To measure changes in bone biomarkers in the serum and urine of study participants not receiving chronic red blood cell transfusions at 3 time points: baseline, 3-months, and 6-months after initiation of alendronate
The investigators' goal is to complete primary data analysis by May 2026.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Alendronate group
Single-arm prospective cohort of 30 adult with SCD
Alendronate Sodium
Administer oral alendronate 70 mg once a week x 24 weeks to all study participants
Interventions
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Alendronate Sodium
Administer oral alendronate 70 mg once a week x 24 weeks to all study participants
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Prisoners
* Hospitalizations (for any cause) within 2 weeks of study entry
18 Years
80 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Doris Duke Charitable Foundation
OTHER
University of California, Davis
OTHER
Responsible Party
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Principal Investigators
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Oyebimpe O Adesina, MD, MS
Role: PRINCIPAL_INVESTIGATOR
UC Davis School of Medicine
Locations
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UC Davis Comprehensive Cancer Center
Sacramento, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020095
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
1693339
Identifier Type: -
Identifier Source: org_study_id
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