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NCT Number: NCT06016634

Alendronate 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

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Avascular Necrosis Bone Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Femur Head Necrosis Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Ischemic Necrosis Legg-Calve-Perthes Disease Musculoskeletal Diseases Necrosis Osteonecrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Sickle Cell Anemia

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alendronate sodium

Drug

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

Other names: alendronate tablet, oral alendronate, Fosamax, Binosto

Primary outcomes

  1. 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

  2. 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

  3. 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.

Secondary outcomes

  1. Bone turnover markers

    Time frame: Baseline, then every 2 months until end of study

    Measure longitudinal changes in of biomarkers for osteoclast (bone resorption) and osteoblast (bone formation) activity

  2. Inflammatory biomarkers

    Time frame: Baseline, then every 2 months until the end of the study

    Measure longitudinal changes in inflammatory biomarkers from baseline to the end of the study

  3. Vascular adhesion biomarkers

    Time frame: Baseline, then every 2 months until the end of the study

    Measure longitudinal changes in biomarkers of vascular adhesion from baseline until the end of the study

Study contacts

Contact information is provided by the study sponsor or research team.

Leyla Y Teos, PhD

CONTACT

[email protected]

(916) 460-2749

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Doris Duke Charitable Foundation
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

A Feasibility Study of Alendronate as Treatment for Osteonecrosis in Adults With Sickle Cell Disease

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 30, 2023
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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