Safety and Tolerability of Intravenous LLP2A-Alendronate for Osteopenia Secondary to Glucocorticoids (NCT03197623) | Clinical Trial Compass
CompletedPhase 1
Safety and Tolerability of Intravenous LLP2A-Alendronate for Osteopenia Secondary to Glucocorticoids
United States58 participantsStarted 2016-10-14
Plain-language 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
Who can participate
Age range20 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 20 - 85 years old
✓. Receiving 5 - 40 mg/day prednisone, or equivalent of another GC (methylprednisolone 4 mg/day, or prednisone 10 mg every other day) for a minimum of 4 consecutive weeks prior to enrollment
✓. Anticipated to continue to receive at least 5 mg/day prednisone or equivalent throughout study participation
✓. T score ≤ -1.0 in the femoral neck or total hip or lumbosacral spine. Only one result from one of these locations that is ≤ -1.0 is required. For screening DXA, a DXA completed within 6 months of screening may be used; otherwise DXA must be completed within 4 weeks of screening visit.
✓. Must be ambulatory and able to attend all appointments
✓. Women must agree to use one of the following methods of birth control for the duration of the clinical trial: systemic hormonal contraceptive (oral, injected, transdermal), intrauterine device, double barrier (e.g., cervical cap or diaphragm with condom or spermicide). Men with female partners must agree to use double barrier contraception, unless their partner is using systemic hormonal contraceptives or has an intrauterine device.
✓. In the opinion of the investigator, the concurrent medical conditions of the study subject are stable
✓. Subject undergoing PET/CT scans must have the ability to lay motionless for up to 30-45 minutes
Exclusion criteria
✕. Weight greater than the limit of the DXA table at the clinical site
✕
What they're measuring
1
Dose limiting Adverse events
Timeframe: Duration of the Study, average of 4 years
. History or concurrent conditions that might place the subject at increased risk, such as renal insufficiency (CKD 4 or 5), glomerulonephritis, atypical infections due to impaired immunity, hypersensitivity to multiple IV medications
✕. History of or concurrent presence of medical conditions which might interfere with ability to participate for the duration of the study, such as clinically significant cardiovascular disease, uncontrollable hypertension, uncontrolled asthma, symptomatic pulmonary fibrosis, recent GI bleeding requiring transfusion, psychosis, substance abuse or hospital admission within 6 months of enrollment (except for elective procedures)
✕. Prior use or current need for prohibited concomitant medications
✕. Rheumatic disease with clinically significant renal or central nervous system involvement
✕. History of deep vein thrombosis (DVT) along with taking any prophylaxis/treatment that occurred within the last 5 years
✕. History of clinically significant atrial fibrillation and/or taking medications for its treatment and prevention
✕. Unable or unwilling to comply with restrictions on alcohol 9. Previous hypersensitivity to alendronate