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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02499237 |
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Date of registration:
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14/07/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Zoledronic Acid to Maintain Bone Mass After Denosumab Discontinuation
AfterDmab |
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Scientific title:
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The Effect of Zoledronic Acid Infusion in the Bone Loss Observed Following Denosumab Discontinuation in Postmenopausal Women With Low Bone Mass |
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Date of first enrolment:
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July 2015 |
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Target sample size:
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57 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02499237 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Greece
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Contacts
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Name:
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Polyzois Makras, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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251 Airforce and VA General Hospital |
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Name:
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Athanasios D Anastasilakis, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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424 General Military Hospital, Thessaloniki, Greece |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- postmenopausal women
- osteopenic (T-score > -2.5 but < -1.0) after treatment with denosumab
Exclusion Criteria:
- secondary osteoporosis;
- diseases that could affect bone metabolism;
- medications that could affect bone metabolism;
- history of any antiosteoporotic treatment other than denosumab prior to randomization
- severe liver or kidney disease (creatinine clearance < 60ml/min/1.73m2)
Age minimum:
50 Years
Age maximum:
N/A
Gender:
Female
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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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Drug: Zoledronic acid
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Drug: Denosumab
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Primary Outcome(s)
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bone mineral density of the lumbar spine
[Time Frame: from 12 to 24 months]
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Secondary Outcome(s)
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C-terminal telopeptide of type I collagen
[Time Frame: from 12 to 15, 18, 24 months]
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propeptide of procollagen type I
[Time Frame: from 12 to 15, 18, 24 months]
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bone mineral density of the lumbar spine
[Time Frame: from baseline to 12 months]
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bone mineral density of the femoral neck
[Time Frame: from 12 to 24 months]
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bone mineral density of the femoral neck
[Time Frame: from baseline to 12 months]
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Secondary ID(s)
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AfterDmab
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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