Safety and Tolerability of Intravenous LLP2A-Alendronate for Osteopenia Secondary to Glucocorticoids

PHASE1CompletedINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

October 14, 2016

Primary Completion Date

March 15, 2021

Study Completion Date

March 31, 2021

Conditions
OsteopeniaOsteoporosisOsteonecrosis
Interventions
DRUG

LLP2A-ALENDRONATE

A small molecule, LLP2A-Ale that directs endogenous mesenchymal stem cells (MSCs), the cells that have the potential to grow bone tissue, to the bone surface to form new bone. Single administration of LLP2A-Ale given intravenously over 120 minutes.

DRUG

Placebo

Placebo, one time single administration given intravenously over 120 minutes.

Trial Locations (4)

16635

Altoona Center for Clinical Research, Duncansville

75231

Metroplex Clinical Research Center, Dallas

92626

West Coast Clinical Trials (WCCT), Cypress

94598

Diablo Clinical Research, Walnut Creek

All Listed Sponsors
collaborator

California Institute for Regenerative Medicine (CIRM)

OTHER

lead

Nancy E. Lane, MD

OTHER

NCT03197623 - Safety and Tolerability of Intravenous LLP2A-Alendronate for Osteopenia Secondary to Glucocorticoids | Biotech Hunter | Biotech Hunter