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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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19 February 2015 |
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Main ID: |
NCT01799798 |
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Date of registration:
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14/02/2013 |
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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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Translational Therapy in Patients With Osteogenesis Imperfecta - A Pilot Trial on Treatment With the Rankl-Antibody Denosumab
OI-AK |
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Scientific title:
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TRANSLATIONAL THERAPY IN PATIENTS WITH OSTEOGENESIS IMPERFECTA - A PILOT TRIAL ON TREATMENT WITH THE RANKL-ANTIBODY DENOSUMAB |
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Date of first enrolment:
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February 2013 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01799798 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Germany
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Contacts
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Name:
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Joerg Oliver Semler, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Cologne, Childrens Hospital, Cologne, Germany |
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Key inclusion & exclusion criteria
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Inclusion Criteria
- Male or female subjects between 5 years and 10 years of age with molecular proven
Osteogenesis imperfecta (COL1A1/A2 mutation)
- Subjects must have been treated for a minimum of 2 years with bisphosphonates prior
to study entry
Exclusion Criteria:
- Hypocalcemia (<1.03 mmol/l ionized Calcium)
- Subjects with reduced renal function (estimated GFR (Schwartz formula)
<30ml/min/1.73m2)
- Any other abnormal finding such as physical examination or laboratory evaluation, in
the opinion of the investigator that is indicative of a disease that would compromise
the safety of the patient when getting denosumab s.c.
Age minimum:
5 Years
Age maximum:
11 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Osteogenesis Imperfecta
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Intervention(s)
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Drug: Denosumab
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Primary Outcome(s)
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Changes of bone mineral density (BMD [g/cm2]) in lumbar spine after 36 weeks of treatment with denosumab. Changes will be calculated between baseline and study week 48.
[Time Frame: 48 weeks]
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Secondary Outcome(s)
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Parathormone in study week 12, 24, 36 and 48 compared to baseline.
[Time Frame: 12 weeks]
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N-Telopeptides in study week 12, 24, 36 and 48 compared to baseline.
[Time Frame: 12 weeks]
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Decrease of osteoclastic activity measured by urinary deoxypyridinoline (DPD).
[Time Frame: 14 days (DPD)]
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Osteocalcin in study week 12, 24, 36 and 48.
[Time Frame: 12 weeks]
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Secondary ID(s)
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Uni-Koeln-1574
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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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