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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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19 March 2012 |
Main ID: |
EUCTR2004-000248-25-HU |
Date of registration:
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04/08/2004 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A multinational, multicenter, randomized, double-blind,
double-dummy, stratified, active controlled parallel group
study comparing the efficacy and safety of intravenous
zoledronic acid, 5 mg once yearly, and oral risedronate, 5
mg daily, in the prevention and treatment of corticosteroid
induced osteoporosis
- 2306
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Scientific title:
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A multinational, multicenter, randomized, double-blind,
double-dummy, stratified, active controlled parallel group
study comparing the efficacy and safety of intravenous
zoledronic acid, 5 mg once yearly, and oral risedronate, 5
mg daily, in the prevention and treatment of corticosteroid
induced osteoporosis
- 2306 |
Date of first enrolment:
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04/08/2004 |
Target sample size:
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900 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000248-25 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open:
Single blind:
Double blind: yes
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other:
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Phase:
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Countries of recruitment
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Czech Republic
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Hungary
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Spain
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria: (for full list see protocol): • Male and female patients 18 to 85 years age old • Patients treated with at least 7.5 mg of oral prednisone per day (or equivalent systemic corticosteroid) and expected to continue corticosteroids therapy for at least a 12 month period: Treated for less or equal to 3 months prior to study entry (prevention sub-population) Treated for more than 3 months prior to study entry (treatment sub-population). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria: (for full list see protocol): • Any prior use of bisphosphonate preparations except according to the washout schedule at time of randomization: 2 years (if use >48 weeks) 1 year (if used >8 weeks but <48 weeks) 6 months (if used >2 weeks but <8 weeks) 2 months (if used <2 weeks) • Any prior use of i.v. bisphosphonate within 2 years prior to randomization
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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corticosteroid induced osteoporosis
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Intervention(s)
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Product Name: zoledronic acid Product Code: ZOL446 Pharmaceutical Form: Solution for infusion INN or Proposed INN: zoledronic acid Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 0.05- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use
Trade Name: Product Name: Actonel Product Code: -- Pharmaceutical Form: Capsule* INN or Proposed INN: risedronate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5.0- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Primary end point(s): • DXA measurements of the lumbar spine, hip and distal radius at baseline, Months 6 and 12. • Height Measurements at baseline, Months 6 and 12. • Bone Marker Analysis (specialized serum tests for CTx, P1NP, bone specific alkaline phosphatase and urinary NTx - markers associated with osteoporosis yet to be identified could be performed in addition) prior to receiving the first dose of study drug and at all subsequent visits until Month 12. • Clinical and morphometric fractures • Lateral X-ray of the lumbar and thoracic spine to assess vertebral fractures at baseline and month 12
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Secondary Objective: • To assess the percent change in BMD at the total hip, femoral neck, trochanter, and distal radius at Month 6 and Month 12 relative to baseline in patients treated with zoledronic acid compared to patients treated with risedronate. • To assess changes in biochemical markers of the bone turnover at Day 10, Month 3, Month 6, and Month 12 relative to baseline in patients treated with zoledronic acid compared to patients treated with risedronate. • To evaluate the overall safety of zoledronic acid compared to risedronate in patients receiving corticosteroid therapy.
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Main Objective: to demonstrate that the percent change in lumbar spine BMD at Month 12 relative to baseline in male and female patients treated with one iv zoledronic acid 5 mg dose at randomization is not inferior to the percent change in lumbar spine BMD at Month 12 compared to baseline in those patients who are treated with oral risedronate 5 mg daily.
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Secondary ID(s)
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CZOL446O2306
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Source(s) of Monetary Support
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Results
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Results available:
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Date Completed:
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