Not Signed In -
Valproic Acid Injection |
Depacon; Valproate Sodium |
Clinical Trial: Safety and Efficacy Trial with Zoledronic Acid for the Treatment of Paget's Disease of Bone
This study is no longer recruiting patients.
|
Purpose
The primary objective of this study was to show non-inferiority of zoledronic acid to risedronate, with respect to the proportion of patients who achieved therapeutic response.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Paget's Disease of Bone | Drug: zoledronic acid | Phase III |
MedlinePlus related topics: Paget's Disease of Bone
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Randomized, Double-Blind, Safety and Efficacy Trial with Intravenous Zoledronic Acid for the Treatment of Paget's Disease of Bone using Risedronate as a Comparator
Study start: April 2002
Efficacy: The primary efficacy variable was the proportion of patients who achieved therapeutic response. A therapeutic response was defined as a reduction of at least 75% from baseline in serum alkaline phosphatase (SAP) excess (difference between measured level and midpoint to the normal range) or normalization of SAP.
Safety: Safety assessments consisted of monitoring and recording all adverse events and serious adverse events, the regular monitoring of hematology, blood chemistry, serum PTH, and urinalysis, regular measurement of vital signs and the performance of physical examinations. Special safety evaluations included bone biopsies, and the assessment of renal abnormalities.
Eligibility
Ages Eligible for Study: 30 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Male and female aged 30 and above with prior confirmed diagnosis of Paget's disease of bone
- Serum alkaline phosphatase >= 2 times the upper limit of normal
Exclusion Criteria:
- Previous history of hypersensitivity to bisphosphonates
More Information
Publications that report results of this study
Springer. 1st European Conference on Paget's Disease of BoneJune 17-18, 2004, Centro Didattico Policlinico Santa Maria delle Scotte, Siena, Italy. Calcif Tissue Int. 2004 May 27;75(3):263-273 [Epub ahead of print] No abstract available.
[No authors listed] Abstracts of the IOF World Congress on Osteoporosis. 14-18 May 2004, Rio de Janeiro, Brazil. Osteoporos Int. 2004 Apr;15 Suppl 1:S1-S161. No abstract available.
[No authors listed] Abstracts of the 26th Annual Meeting of the American Society for Bone and Mineral Research. October 1-5, 2004, Seattle, Washington, USA. J Bone Miner Res. 2004 Oct;19 Suppl 1:S2-543. No abstract available.
Record last reviewed: February 2005
Last Updated: February 14, 2005
Record first received: February 14, 2005
ClinicalTrials.gov Identifier: NCT00103740
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Depacon (Drug Digest)
- Valproate Sodium (Drug Digest)
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