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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: |
NCT00131469 |
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Date of registration:
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16/08/2005 |
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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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Study of Teriparatide (FORTEO) to Treat Adults With Osteogenesis Imperfecta
OI |
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Scientific title:
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A Study to Assess the Effectiveness of Teriparatide (FORTEO) for Increasing Bone Mass and Improving Bone Strength in Adults Affected With Osteogenesis Imperfecta (OI) |
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Date of first enrolment:
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June 2005 |
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Target sample size:
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79 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00131469 |
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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: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Sandra Veith, CRA |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oregon Health and Science University |
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Name:
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Brendan Lee, M.D., 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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Balor College of Medicine |
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Name:
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Jay Shapiro, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hugo W. Moser Research Institute at Kennedy Krieger, Inc. |
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Name:
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Eric S Orwoll, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oregon Health and Science University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Previous established diagnosis of Osteogenesis Imperfecta AND
- > 2 previous adult fractures, AND/OR
- BMD at lumbar spine, femoral neck or total hip T score < -2.0
Exclusion Criteria:
- Open epiphyses.
- History of external beam radiation to the skeleton.
- Pagets disease.
- Bone metastases or skeletal malignancies.
- Total lifetime exposure to any antiresorptive medication < 90 days (Primary
Inclusion).
- Treatment with any antiresorptive medication 12 months proceeding enrollment -
(Secondary Inclusion).
- Women with OI who are pregnant or unwilling to use 1 form of contraception.
- Vitamin D insufficiency (25-hydroxyvitamin D <15ng/ml)
Age minimum:
18 Years
Age maximum:
85 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: Placebos
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Drug: Teriparatide (FORTEO)
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Primary Outcome(s)
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Spine Bone Mineral Density (BMD)
[Time Frame: baseline and 18 months]
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Secondary Outcome(s)
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Total Hip BMD
[Time Frame: baseline and 18 months]
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Secondary ID(s)
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UL1RR024140
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IBMD-OI
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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