Status:
COMPLETED
Evaluation of Efficacy of Zoledronic Acid in Patients With Haemoglobin Syndromes (Thalassemia and Sicle Cell Anaemia) and Risk of Skeletal Events
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Thalassemia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- \-
- Other protocol-defined inclusion / exclusion criteria may apply.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00346242
Start Date
March 1 2004
Last Update
May 1 2012
Active Locations (1)
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1
Novartis Investigative Site
Athens, Greece