Back to resultsEvaluation of Efficacy of Zoledronic Acid in Patients With Haemoglobin Syndromes (Thalassemia and Sicle Cell Anaemia) and Risk of Skeletal Events
Primary Purpose
Thalassemia
Status
Completed
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Zoledronic Acid
Sponsored by
About this trial
This is an interventional prevention trial for Thalassemia focused on measuring thalassemia, zoledronic acid, skeletal events
Eligibility 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.
Sites / Locations
- Novartis Investigative Site
Outcomes
Primary Outcome Measures
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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00346242
Brief Title
Evaluation of Efficacy of Zoledronic Acid in Patients With Haemoglobin Syndromes (Thalassemia and Sicle Cell Anaemia) and Risk of Skeletal Events
Official Title
Evaluation of Efficacy of Zoledronic Acid in Patients With Haemoglobin Syndromes (Thalassemia and Sicle Cell Anaemia) and Risk of Skeletal Events
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thalassemia
Keywords
thalassemia, zoledronic acid, skeletal events
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Zoledronic Acid
Primary Outcome Measure Information:
Title
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
Title
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
Title
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 Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis Investigative Site
City
Athens
Country
Greece
12. IPD Sharing Statement
Citations:
PubMed Identifier
19407319
Citation
Voskaridou E, Christoulas D, Xirakia C, Varvagiannis K, Boutsikas G, Bilalis A, Kastritis E, Papatheodorou A, Terpos E. Serum Dickkopf-1 is increased and correlates with reduced bone mineral density in patients with thalassemia-induced osteoporosis. Reduction post-zoledronic acid administration. Haematologica. 2009 May;94(5):725-8. doi: 10.3324/haema-tol.2008.000893. Erratum In: Haematologica. 2009 Aug;94(8):1182.
Results Reference
derived
Learn more about this trial
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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