Recruiting
Phase 2

Alendronate

Sponsor:

UCLA

Code:

NCT06016634

Conditions

Sickle Cell Disease

Sickle Cell Anemia

Osteonecrosis

Ischemic Necrosis

Avascular Necrosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Alendronate Sodium

Study Details

Brief summary:

A prospective, single-arm, intervention study of oral alendronate in adults with sickle cell disease and osteonecrosis

Conditions

Sickle Cell Disease

Sickle Cell Anemia

Osteonecrosis

Ischemic Necrosis

Avascular Necrosis

Study ID

NCT06016634

Start date

Mar 9, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Alendronate group

Single-arm prospective cohort of 30 adult with SCD

Interventions

Alendronate Sodium

Administer oral alendronate 70 mg once a week x 24 weeks to all study participants

Primary outcome measure

  • Recruitment and retention rates [ Time Frame: up to 28 weeks ]
  • Incidence of Treatment-Emergent Adverse Events as assessed by participant report [ Time Frame: up to 28 weeks ]
  • Pain assessed by the Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me) Pain Impact questionnaire [ Time Frame: up to 28 weeks ]

Central Contacts and Locations

Central contacts

Leyla Y Teos, PhD

(916) 460-2749lyteos@health.ucdavis.edu

Locations

UC Davis Comprehensive Cancer Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Leyla Y Teos, PhD

916-460-2749lyteos@ucdavis.edu

Oyebimpe O Adesina, MD, MS

(916) 703-5166adesina@ucdavis.edu

Principal Investigator:

Oyebimpe O Adesina, MD, MS

More Information

Sponsor

University of California, Davis

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Keywords

  • sickle cell disease
  • sickle cell anemia
  • osteonecrosis of the femoral head
  • hip osteonecrosis
  • ischemic necrosis of the femur
  • avascular necrosis of the femur

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-07-16.