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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: |
NCT03208582 |
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Date of registration:
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23/05/2017 |
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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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Do Bisphosphonates Alter the Skeletal Response to Mechanical Stimulation in Children With Osteogenesis Imperfecta?
BAMES |
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Scientific title:
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Do Bisphosphonates Alter the Skeletal Response to Mechanical Stimulation in Children With Osteogenesis Imperfecta? |
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Date of first enrolment:
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April 1, 2017 |
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Target sample size:
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13 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03208582 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Nick Bishop, MD, FRCPCH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sheffield Children's Hospital and University of Sheffield |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age 4-16 years
- Able to speak fluent English
- Diagnosed with osteogenesis imperfecta
- Able to stand
- Not treated with bisphosphonates
Exclusion Criteria:
- Presence of other chronic illnesses
- Balance problems
- Recent fracture (in the last 6 months)
- Recent (last 12 months) or current treatment likely to affect bone - this does not
include inhaled or intermittent oral therapy with steroids for asthma
- Involvement in another interventional research project
Age minimum:
4 Years
Age maximum:
16 Years
Gender:
All
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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: Risedronate Sodium
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Dietary Supplement: Calcichew tablets
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Primary Outcome(s)
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Change in P1NP response to 1 week of vibration without risedronate treatment, followed by a washout period. Change in P1NP response to vibration will be reassessed following Risedonate treatment. Serial bone markers will be done over a 99 day period.
[Time Frame: 99 days]
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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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