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Evaluation of Efficacy of Zoledronic Acid in Patients With Haemoglobin Syndromes (Thalassemia and Sicle Cell Anaemia) and Risk of Skeletal Events

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ClinicalTrials.gov Identifier: NCT00346242
Recruitment Status : Completed
First Posted : June 29, 2006
Last Update Posted : May 1, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
The evaluation of efficacy is performed by laboratory monitoring of bone density and resorption markers and clinical monitoring of bone density improvement. This is a prospective, randomized, parallel group, single blind study of one year treatment with zoledronic acid every 6 months as compared to one year treatment with zoledronic acid every 3 months and to placebo every 3 months in patients with hemoglobin syndromes and risk of skeletal complications.

Condition or disease Intervention/treatment Phase
Thalassemia Drug: Zoledronic Acid Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Evaluation of Efficacy of Zoledronic Acid in Patients With Haemoglobin Syndromes (Thalassemia and Sicle Cell Anaemia) and Risk of Skeletal Events
Study Start Date : March 2004
Actual Primary Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Thalassemia

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Bone density by means of bone densitometry with dual energy x-ray absorptiometry (DEXA) at three body sites (lumbar region, femoral head, wrist) prior to treatment initiation the start and at the end of treatment
  2. N-telopeptide of type I collagen (NTx) levels, TRACP-5b, with ELISA, prior to the start of treatment initiation and every 3 or 6 months
  3. Serum Bone alkaline phosphatase, Osteocalcin, OPG and S-RANKL with ELISA, prior to the start of treatment initiation, and every 3 or 6 months

Secondary Outcome Measures :
  1. Biochemistry (Ca, P, urea/creatinine, SGOT/SGPT, ALT, γGT), endocrine and cardiac test prior to the start of treatment initiation and at 6 and 12 month.

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with thalassaemia or sickle cell anaemia and bone density, z-scores < -1.5, in at least one of the examined sites
  • Normal renal function. Urea and creatinine should not exceed > 2-fold the upper limit of normal (< 2 x ULN).

Exclusion Criteria:

-

Other protocol-defined inclusion / exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00346242


Locations
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Greece
Novartis Investigative Site
Athens, Greece
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Chair: Novartis Novartis
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00346242    
Other Study ID Numbers: CZOL446EGR05
First Posted: June 29, 2006    Key Record Dates
Last Update Posted: May 1, 2012
Last Verified: April 2012
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
thalassemia
zoledronic acid
skeletal events
Additional relevant MeSH terms:
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Thalassemia
Anemia
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
 Hemoglobinopathies
Genetic Diseases, Inborn
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs