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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: |
NCT02090244 |
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Date of registration:
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16/03/2014 |
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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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Does PTH 1-34 (Teriparatide) Enhance Spinal Fusion in Humans?
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Scientific title:
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Förbättrar PTH Postero-lateral fusionsläkning Vid Ryggkirurgi? |
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Date of first enrolment:
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August 2012 |
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Target sample size:
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34 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02090244 |
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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: Single (Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Jon Ottesen, 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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Ryggkliniken, US Linköping |
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Name:
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Patrik Bernestrå, 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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Ortopedkliniken, Kalmar, Sweden |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- lumbar spinal stenosis operated on with decompression and bone grafting. All ages are
accepted, but women must be postmenopausal.
Exclusion Criteria:
- •dementia or psychiatric disorder
- known malignancy < 5 years prior to fracture
- calcium above reference value
- signs of liver disease
- creatinine over ref. value
- inflammatory joint disease
- alcohol or drug abuse
- oral corticosteroid medication
- long-term NSAID-treatment (=> 3 months prior to fracture)
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Spinal Stenosis
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Intervention(s)
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Drug: Teriparatide
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Primary Outcome(s)
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The rate of bone healing after spinal stenosis surgery
[Time Frame: 6 months + more than 2 years postoperatively.]
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Secondary Outcome(s)
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Pain
[Time Frame: At 3 and 6 months.]
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Function
[Time Frame: At 3 and 6 months.]
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Secondary ID(s)
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2011-002917-12
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PTH spinal stenosis
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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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