Alendronate for Osteonecrosis in Adults With Sickle Cell Disease

NCT06016634 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 16933395K23HL1483102020095
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Recruitment and retention rates

  Proportion of eligible patients who get recruited to the study; number of enrolled patients who complete 6-month study

  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

  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.

  up to 28 weeks

Secondary Outcomes (2)

• Serum CTX-1

  baseline, 3 months, 6 months

• Serum P1NP

  baseline, 3 months, 6 months

Study Arms (1)

Alendronate group

EXPERIMENTAL

Single-arm prospective cohort of 30 adult with SCD

Drug: Alendronate Sodium

Interventions

Alendronate Sodium DRUG

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

Also known as: alendronate tablet, oral alendronate, Fosamax, Binosto

Alendronate group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Doris Duke Charitable Foundation: collaborator
• University of California, Davis: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

UC Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

RECRUITING

MeSH Terms

Conditions

Anemia, Sickle Cell; Osteonecrosis; Legg-Calve-Perthes Disease

Interventions

Alendronate

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Femur Head Necrosis

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Study Officials

• Oyebimpe O Adesina, MD, MS

  UC Davis School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leyla Y Teos, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective cohort of 30 adults with sickle cell disease and hip osteonecrosis

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 30, 2023
• Study Start: March 9, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)