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
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|Condition or disease||Intervention/treatment||Phase|
|Thalassemia||Drug: Zoledronic Acid||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|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|
- 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
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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).
Other protocol-defined inclusion / exclusion criteria may apply.
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
|Novartis Investigative Site|
|Responsible Party:||Novartis Pharmaceuticals|
|Other Study ID Numbers:||
|First Posted:||June 29, 2006 Key Record Dates|
|Last Update Posted:||May 1, 2012|
|Last Verified:||April 2012|
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Bone Density Conservation Agents
Physiological Effects of Drugs