Sickle Cell DiseasePhase 2NCT06016634
Alendronate for Osteonecrosis in Adults With Sickle Cell Disease
A Phase 2 study testing Alendronate Sodium in people with Sickle Cell Disease and Sickle Cell Anemia, run by University of California, Davis at 1 site in United States.
Trial summary
A prospective, single-arm, intervention study of oral alendronate in adults with sickle cell disease and osteonecrosis Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sickle Cell Disease, Sickle Cell Anemia, Osteonecrosis
- What is being tested?
- Alendronate Sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2026to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817
Leyla Y Teos, PhD, 916-460-2749, lyteos@ucdavis.edu
Oyebimpe O Adesina, MD, MS, (916) 703-5166, adesina@ucdavis.edu
About this study
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
Read the detailed 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 also be collected to assess changes in bone biomarkers at baseline, 3-months, and 6-months.
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
- Sickle Cell Disease, Sickle Cell Anemia, Osteonecrosis, Ischemic Necrosis, Avascular Necrosis
- Being tested
- Alendronate Sodium
- Keywords
- sickle cell disease, sickle cell anemia, osteonecrosis of the femoral head, hip osteonecrosis, ischemic necrosis of the femur, avascular necrosis of the femur
- Medical subject headings
- Anemia, Sickle Cell, Osteonecrosis, Legg-Calve-Perthes Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alendronate SodiumDrug
Also called alendronate tablet, oral alendronate, Fosamax, Binosto
Administer oral alendronate 70 mg once a week x 24 weeks to all study participants
| Study group | Role | What they receive |
|---|---|---|
| Alendronate group | Experimental | Single-arm prospective cohort of 30 adult with SCD Receives: Drug: Alendronate Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment and retention rates
Proportion of eligible patients who get recruited to the study; number of enrolled patients who complete 6-month study
Measured: up to 28 weeks
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
Measured: up to 28 weeks
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.
Measured: up to 28 weeks
Secondary outcomes (3)
Bone turnover markers
Measure longitudinal changes in of biomarkers for osteoclast (bone resorption) and osteoblast (bone formation) activity
Measured: Baseline, then every 2 months until end of study
Inflammatory biomarkers
Measure longitudinal changes in inflammatory biomarkers from baseline to the end of the study
Measured: Baseline, then every 2 months until the end of the study
Vascular adhesion biomarkers
Measure longitudinal changes in biomarkers of vascular adhesion from baseline until the end of the study
Measured: Baseline, then every 2 months until the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start9 Mar 2026
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort of 30 adults with sickle cell disease and hip osteonecrosis
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Doris Duke Charitable Foundation
- Responsible party
- Sponsor
- Investigators
- Oyebimpe O Adesina, MD, MS, Principal investigator, UC Davis School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016634
- Sponsor's protocol ID
- 1693339
- Other IDs
- 5K23HL148310, 2020095
- Status last verified
- Jul 2026
- First submitted
- 7 Aug 2023
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Alendronate as Treatment for Osteonecrosis in Adults With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT06016634
- Acronym / sponsor ID
- 1693339
- Conditions
- Sickle Cell Disease, Sickle Cell Anemia, Osteonecrosis, Ischemic Necrosis, Avascular Necrosis
- Keywords
- sickle cell disease, sickle cell anemia, osteonecrosis of the femoral head, hip osteonecrosis, ischemic necrosis of the femur, avascular necrosis of the femur
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Doris Duke Charitable Foundation
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, single-arm, intervention study of oral alendronate in adults with sickle cell disease and osteonecrosis
Detailed 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 also be collected to assess changes in bone biomarkers at baseline, 3-months, and 6-months.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort of 30 adults with sickle cell disease and hip osteonecrosis
| Arm | Type | Receives |
|---|---|---|
| Alendronate group | Experimental | Drug: Alendronate SodiumSingle-arm prospective cohort of 30 adult with SCD |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alendronate SodiumAlso: alendronate tablet, oral alendronate, Fosamax, BinostoAdminister oral alendronate 70 mg once a week x 24 weeks to all study participants | Drug | Alendronate group |
Primary outcome
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.
3 secondary outcomes
Bone turnover markers
Time frame: Baseline, then every 2 months until end of study
Inflammatory biomarkers
Time frame: Baseline, then every 2 months until the end of the study
Vascular adhesion biomarkers
Time frame: Baseline, then every 2 months until the end of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oyebimpe O Adesina, MD, MS principal investigator
UC Davis School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alendronate Sodium in people with Sickle Cell Disease and Sickle Cell Anemia, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leyla Y Teos, PhD ((916) 460-2749, lyteos@health.ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment and retention rates (time frame: up to 28 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.