A study to see if alendronate (Fosamax) reduces bone pain from osteonecrosis in adults with sickle cell disease

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a study on Sickle Cell Anemia Anemia Osteonecrosis Ischemic Necrosis Avascular Necrosis

Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at UC Davis
Dates
study started
study ends around
Principal Investigator
by Oyebimpe O Adesina, MD, MS (ucdavis)
Headshot of Oyebimpe O Adesina
Oyebimpe O Adesina

Description

Summary

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

Official Title

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

Details

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.

Keywords

Sickle Cell Disease, Sickle Cell Anemia, Osteonecrosis, Ischemic Necrosis, Avascular Necrosis, osteonecrosis of the femoral head, hip osteonecrosis, ischemic necrosis of the femur, avascular necrosis of the femur, Legg-Calve-Perthes Disease, Alendronate, Alendronate Sodium

Eligibility

You can join if…

Open to people ages 18-80

  • 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 CAN'T join 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

Location

  • UC Davis Comprehensive Cancer Center accepting new patients
    Sacramento California 95817 United States

Lead Scientist at University of California Health

  • Oyebimpe O Adesina, MD, MS (ucdavis)
    Associate Professor, MED: Int Med Hematology/Oncology, School of Medicine. Authored (or co-authored) 14 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT06016634
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated
Contact us about this trial