Summary

Eligibility
for people ages 18-80 (full criteria)
Dates
study started
completion around
Principal Investigator
by Oyebimpe O Adesina, MD, MS (ucdavis)

Description

Summary

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

Official Title

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

Details

The investigators hypothesize that adults with sickle cell disease (SCD) and osteonecrosis of the femoral head (ONFH) will tolerate oral alendronate 70 mg administered once a week for 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 2023- Dec 2024.

The study endpoints are summarized below:

  • To determine the recruitment and retention rates of adults with SCD-related ONFH 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 ONFH 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 2025.

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, Necrosis, 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

Lead Scientist at University of California Health

  • Oyebimpe O Adesina, MD, MS (ucdavis)
    Assistant Professor, Hematology and Oncology, School of Medicine. Authored (or co-authored) 10 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT06016634
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 24 study participants
Last Updated