Clinical Trials Logo

Clinical Trial Summary

A Phase 1 Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study of the Safety and Tolerability of Intravenous LLP2A-Alendronate in Adult Men and Women with Osteopenia Secondary to Corticosteroids


Clinical Trial Description

The study is designed to evaluate safety and tolerability of LLP2A-Ale beginning with a single ascending dose (SAD) cohort followed by multiple ascending dose (MAD) cohorts with matching placebo in each cohort. The population in this study includes patients with low bone density (osteopenia with a T score ≤ -1.0) in the femoral neck, total hip or lumbosacral spine who are taking Corticosteroids. Up to 59 patients will be enrolled, 32 in the SAD and 27 in the MAD. LLP2A-Ale is a novel anabolic agent. It appears that LLP2A-Ale may have utility in a variety of conditions where new bone formation is required. Non-traumatic osteonecrosis (ON) has been selected as the first indication for LLP2A-Ale because of the high unmet need, absence of treatments besides surgical joint replacement, and the clear need to attract and stimulate differentiation of stem cells into the region of necrotic bone. However, osteonecrosis is a rare, sporadic disease. Therefore, the Phase 1 study is being performed in people at risk for osteonecrosis, as a population representative of people with osteonecrosis, who will be the participants in any subsequent Phase 2 and 3 studies. Non-traumatic ON may also be caused by a variety of underlying medical conditions. Glucocorticoid use, alcohol, and smoking contribute to up to 80% of cases of nontraumatic ON. The relationship to GC is the strongest in people receiving relatively long term therapy, with risk increasing with cumulative exposure over three or more months. Vasculitis from autoimmune diseases predisposes to ON and ON is particularly associated with Systemic Lupus Erythematous (SLE), possibly due to coexistence of vasculitis and chronic GC treatment. In different series, symptomatic ON is reported in about 5-30% of SLE patients. Because many foci of ON are asymptomatic, rates based on MRI surveillance are higher, in the range of 30 - 50%, and often are multifocal. Because of the particularly high incidence of ON in SLE we anticipate that SLE patients will be a significant component of the population in later trials. Therefore investigators in this Phase 1 trial include rheumatologists in order to increase the likelihood of inclusion of lupus patients in this first study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03197623
Study type Interventional
Source University of California, Davis
Contact
Status Completed
Phase Phase 1
Start date October 14, 2016
Completion date March 31, 2021

See also
  Status Clinical Trial Phase
Active, not recruiting NCT06287502 - Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis N/A
Completed NCT03822078 - Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Denosumab (AMG 162) in Japanese Postmenopausal Women Phase 1
Recruiting NCT05845021 - Surgeon-Initiated Bone Health Referral Pathway in Patients Undergoing Lower Extremity Arthroplasty N/A
Completed NCT00092066 - A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227) Phase 3
Recruiting NCT04754711 - Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition N/A
Completed NCT04736693 - Replication of the HORIZON Pivotal Fracture Trial in Healthcare Claims Data
Not yet recruiting NCT06431867 - Primary Care Management of Osteoporosis in Older Women
Completed NCT02922478 - Role of Comorbidities in Chronic Heart Failure Study
Recruiting NCT02635022 - Fragility Fracture Liaison Service and Anti-osteoporosis Medication Monitoring Service Study
Recruiting NCT02616627 - Association Between DXA Results and the Complications, Clinical Courses and Outcomes in Chronic Dialysis Patients
Active, not recruiting NCT02617303 - Prevention of Falls and Its Consequences in Elderly People N/A
Completed NCT02566655 - Clinical Trial of Intravenous Infusion of Fucosylated Bone Marrow Mesenchyme Cells in Patients With Osteoporosis Phase 1
Completed NCT03420716 - Symbiotic Yogurt, Calcium Absorption and Bone Health in Young Adult Women N/A
Completed NCT02559648 - Denosumab vs Placebo in Patients With Thalassemia Major and Osteoporosis Phase 2
Not yet recruiting NCT02223572 - Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture N/A
Not yet recruiting NCT01854086 - Compliance and Persistence With Osteoporosis Treatment and Attitude Towards Future Therapy Among Post-menopausal Israeli Women During Drug Treatment or Drug Holiday N/A
Completed NCT02003716 - DeFRA Questionnaire as an Anamnestic Form N/A
Unknown status NCT01913834 - Nasally and sc Administered Teriparatide in Healthy Volunteers Phase 1
Completed NCT01401556 - C-STOP Fracture Trial N/A
Completed NCT01757340 - Calorie Restriction With Leucine Supplementation N/A