Phase 1 Study of Zoledronic Acid in Sickle Cell Disease

This study has been withdrawn prior to enrollment.
(Ended early due to inability to identify eligible subjects)
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00639392
First received: March 14, 2008
Last updated: November 10, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Sickle Cell Disease
Drug: Placebo
Drug: Zoledronic Acid
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: Phase 1 Study of Zoledronic Acid in Sickle Cell Disease

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • The long-term goal of this project is to learn if Zoledronic Acid can prevent or reduce pain in sickle cell disease. [ Time Frame: Within 2 weeks of study drug administration and then every month for approximately 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Two weeks after study drug administration and then every month for approximately 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: June 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2
Patients will receive a single dose of Zoledronic Acid or placebo. The chances that a subject will receive placebo are 1 out of 3.
Drug: Placebo
Patients will receive a single dose of placebo administered by vein over about 15 minutes. Placebo is mostly water without Zoledronic Acid.
Experimental: 1
Patients will receive a single dose of Zoledronic Acid or placebo. The chances that a subject will receive Zolendronic Acid are 2 out of 3.
Drug: Zoledronic Acid
Patients will receive a single dose of Zolendronic Acid. Zoledronic Acid is administered by vein over about 15 minutes.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639392

Locations
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Novartis
Investigators
Principal Investigator: John D Roberts, M.D. Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00639392     History of Changes
Other Study ID Numbers: VCU-PT101439
Study First Received: March 14, 2008
Last Updated: November 10, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Virginia Commonwealth University:
Sickle cell disease

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia
Anemia, Hemolytic
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Hematologic Diseases
Hemoglobinopathies
Diphosphonates
Zoledronic acid
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 28, 2014