Alendronate for Osteonecrosis in Adults With Sickle Cell Disease

Status Not yet recruiting

Clinical Trial Summary

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

Clinical Trial Description

The investigators hypothesize that adults with sickle cell disease (SCD) and osteonecrosis in the hip or shoulder joint(s) will tolerate oral alendronate 70 mg administered once a week for 24 weeks (6 months). In addition to collecting safety and tolerability data of alendronate in study participants, the investigators will measure how alendronate therapy impacts quality of life measures using the Adult Sickle Cell Quality of Life Measurement System (ASCQ-Me) questionnaires from baseline to 3-months and 6-months in study participants. 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 Mar 2024- Feb 2025. 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 July 2025. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06016634
Study type	Interventional
Source	University of California, Davis
Contact	Leyla Y Teos, PhD
Phone	(916) 460-2749
Email	lyteos@ucdavis.edu
Status	Not yet recruiting
Phase	Phase 2
Start date	March 2024
Completion date	July 2025

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02227472` - Working Memory and School Readiness in Preschool-Aged Children With Sickle Cell Disease
Recruiting	`NCT06301893` - Uganda Sickle Surveillance Study (US-3)
Recruiting	`NCT04398628` - ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
Completed	`NCT02522104` - Evaluation of the Impact of Renal Function on the Pharmacokinetics of SIKLOS ® (DARH)	Phase 4
Recruiting	`NCT04688411` - An mHealth Strategy to Improve Medication Adherence in Adolescents With Sickle Cell Disease	N/A
Terminated	`NCT03615924` - Effect of Ticagrelor vs. Placebo in the Reduction of Vaso-occlusive Crises in Pediatric Patients With Sickle Cell Disease	Phase 3
Not yet recruiting	`NCT06300723` - Clinical Study of BRL-101 in Severe SCD	N/A
Recruiting	`NCT03937817` - Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants
Completed	`NCT04917783` - Health Literacy - Neurocognitive Screening in Pediatric SCD	N/A
Completed	`NCT04134299` - To Assess Safety, Tolerability and Physiological Effects on Structure and Function of AXA4010 in Subjects With Sickle Cell Disease	N/A
Completed	`NCT02580565` - Prevalence of Problematic Use of Equimolar Mixture of Oxygen and Nitrous Oxide and Analgesics in the Sickle-cell Disease
Recruiting	`NCT04754711` - Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition	N/A
Completed	`NCT04388241` - Preliminary Feasibility and Efficacy of Behavioral Intervention to Reduce Pain-Related Disability in Pediatric SCD	N/A
Recruiting	`NCT05431088` - A Phase 2/3 Study in Adult and Pediatric Participants With SCD	Phase 2/Phase 3
Completed	`NCT01158794` - Genes Influencing Iron Overload State
Recruiting	`NCT03027258` - Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome	N/A
Withdrawn	`NCT02960503` - Macrolide Therapy to Improve Forced Expiratory Volume in 1 Second in Adults With Sickle Cell Disease	Phase 1/Phase 2
Completed	`NCT02565082` - Evaluation of the Hemostatic Potential in Sickle Cell Disease Patients	N/A
Completed	`NCT02567682` - Drug Interaction Study of GBT440 With Caffeine, S-warfarin, Omeprazole, and Midazolam in Healthy Subjects	Phase 1
Withdrawn	`NCT02630394` - A Pilot Study of Azithromycin Prophylaxis for Acute Chest Syndrome in Sickle Cell Disease	Phase 1