Sickle Cell Disease
Conditions
Keywords
Sickle cell disease
Brief summary
The long-term goal of this study is to learn if Zoledronic Acid can prevent or reduce pain in sickle cell disease. The goal of this study is to learn about the safety of Zoledronic Acid in persons with sickle cell disease who experience chronic pain requiring medical treatment or use of narcotics.
Interventions
DRUGPlacebo
Patients will receive a single dose of placebo administered by vein over about 15 minutes. Placebo is mostly water without Zoledronic Acid.
DRUGZoledronic Acid
Patients will receive a single dose of Zolendronic Acid. Zoledronic Acid is administered by vein over about 15 minutes.
Sponsors
Novartis
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 18 years and older * Male or female with sickle cell disease * Pain related to sickle cell disease Patient history of health services utilization for acute SCD-related pain Patient history of use of narcotic analgesics for pain control within the past 6 months * Able to tolerate hydration with 500 mL D51/2 NS prior to Zoledronic Acid or placebo
Exclusion criteria
* Calculated creatinine clearance less than 60 mL/min * Current active dental problems * Recent (within 6 weeks) or planned dental or jaw surgery (e.g., extraction,implants) * History of cirrhosis or chronic symptomatic liver disease; acute liver disease * History of aspirin-induced asthma * History of allergy to zoledronic acid or similar chemical-entities * Pregnant or nursing * No prior bisphosphonate use * Receipt of an investigational drug within 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The long-term goal of this project is to learn if Zoledronic Acid can prevent or reduce pain in sickle cell disease. | Within 2 weeks of study drug administration and then every month for approximately 1 year |
Secondary
| Measure | Time frame |
|---|---|
| The specific purposes of this study are to learn if Zoledronic Acid has serious side effects for subjects with sickle cell disease and to study the effects of Zoledronic acid in subjects with sickle cell disease. | Two weeks after study drug administration and then every month for approximately 1 year |
Countries
United States
Outcome results
None listed