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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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29 May 2012 |
Main ID: |
EUCTR2004-000638-35-ES |
Date of registration:
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07/10/2004 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A 2-year randomized, multicenter, double-blind, placebocontrolled
study to determine the efficacy and safety of
intravenous zoledronic acid 5 mg administered either
annually at randomization and 12 months, or administered
at randomization only in the prevention of bone loss in
postmenopausal women with osteopenia - 2312
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Scientific title:
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A 2-year randomized, multicenter, double-blind, placebocontrolled
study to determine the efficacy and safety of
intravenous zoledronic acid 5 mg administered either
annually at randomization and 12 months, or administered
at randomization only in the prevention of bone loss in
postmenopausal women with osteopenia - 2312 |
Date of first enrolment:
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28/10/2004 |
Target sample size:
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654 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000638-35 |
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: yes
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Spain
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Sweden
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Key inclusion & exclusion criteria
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Inclusion criteria: Women greater than or equal to 45 years of age inclusive at the time of randomization, considered postmenopausal according to one of the following guidelines: • cessation of menses for 18 months in women < 50 years of age • cessation of menses for 12 months in women age 50 years or over • documented bilateral oophorectomy at least 1 year previously
Women with osteopenia defined as Bone Mineral Density T-score less than -1.0 and greater than - 2.5 at the lumbar spine
Bone Mineral Density T-score value greater than -2.5 at the femoral neck 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: Patiens with more than one Grade 1 vertebral fracture (as per Genant method; patients with one Grade 1 vertebral fracture are eligible to participate)
Patients with any Grade 2 or 3 vertebral fracture (as per Genant method)
Patients with 25-(OH) Vitamin D levels less than 15 ng/mL prior to randomization
Renal insufficiency (calculated creatinine clearance less than 30.0 mL/min) at Visit 1 or Visit 2
Hypercalcemia (serum calcium = 2.75 mmol/L (11.0 mg/dL) at Visit 1
Hypocalcemia (serum calcium = 2.0 mmol/L (8.0 mg/dL) at Visit 1
AST or ALT greater than 2.0 times the upper limit of normal
Serum alkaline phosphatase greater than 1.5 times the upper limit of normal
Age minimum:
Age maximum:
Gender:
Female: yes Male: no
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Health Condition(s) or Problem(s) studied
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Postmenopausal Osteoporosis
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Intervention(s)
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Product Name: zoledronic acid Product Code: ZOL446 Pharmaceutical Form: Intravenous 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
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Primary Outcome(s)
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Secondary Objective: To assess the percent change in BMD at the lumbar spine at Months 6, 12 and 18 relative to baseline in each strata comparing: a) zoledronic acid 5 mg i.v. given at randomization and Month 12 to placebo b) zoledronic acid 5 mg i.v. given at randomization only to placebo c) zoledronic acid 5 mg i.v. given at randomization only to zoledronic acid 5 mg i.v. given at randomization and Month 12 (including Month 24 for this comparison)
To assess the percent change in BMD at the total hip, femoral neck, trochanter, and distal radius at Months 6, 12, 18, and 24 relative to baseline in each strata comparing: (a), (b) and (c) - see above.
To assess the change of biochemical markers of bone resorption and formation at Months 1, 3, 6, 9, 12, 15, 18, and 24 relative to baseline in each strata comparing: (a), (b) and (c) - see above.
To evaluate the overall safety and tolerability of zoledronic acid compared to placebo.
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Main Objective: - To demonstrate that zoledronic acid 5 mg i.v. given annually at randomization and Month 12 is superior to placebo in percent change of BMD at the lumbar spine at Month 24 relative to baseline in Stratum I (women < 5 years from menopause) and in Stratum II (women = 5 years from menopause)
- To demonstrate that zoledronic acid 5 mg i.v. given at randomization only is superior to placebo in percent change of BMD at the lumbar spine at Month 24 relative to baseline in Stratum I and in Stratum II
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Primary end point(s): Change of BMD at the lumbar spine.
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Secondary ID(s)
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CZOL446N2312
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2004-000638-35-SE
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Source(s) of Monetary Support
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Results
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Results available:
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