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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 October 2017 |
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Main ID: |
NCT00365456 |
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Date of registration:
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09/08/2006 |
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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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Sequential Treatment of Postmenopausal Women With Primary Osteoporosis (FP-001-IM)
PEAK |
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Scientific title:
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An Open Label, International, Multi Centre, Parallel Group, Phase III b, Randomised Trial, Investigating Lumbar Spine Bone Mineral Density (BMD) Changes in Postmenopausal Women With Primary Osteoporosis Initially Treated With 12 Months of Full Length Parathyroid Hormone (PTH 1-84) Followed by 12 Months of Treatment With Risedronate Followed by Either 12 Months Treatment With PTH (1-84) or Risedronate. |
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Date of first enrolment:
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July 2006 |
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Target sample size:
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407 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00365456 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Nycomed Clinical Trial Operations |
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Address:
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Telephone:
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Email:
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Affiliation:
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Headquaters |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Women above the age of 50 years with the diagnosis of postmenopausal primary osteoporosis
may be enrolled in the trial if the following inclusion/exclusion criteria apply.
All inclusion criteria must be answered "yes" for a subject to be enrolled in the trial.
1. Has the subject given informed consent according to local requirements before any
trial related activities? (A trial related activity is any procedure that would not
have been performed during the routine management of the subject).
2. Is the subject above 50 years old?
3. Is the subject postmenopausal (more than 5 years) - in the judgement of the
investigator?
4. Does the subject have primary osteoporosis with a lumbar spine T score < -3.0 SD (at
lumbar spine L1-L4, with a minimum of two evaluable vertebrae)?
5. Does the subject have a life expectancy of >3 years?
6. Is the subject able to self-inject PTH (1-84), (or to have PTH (1-84) injection by a
helper)?
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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Osteoporosis
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Intervention(s)
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Drug: Parathyroid Hormone (PTH)
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Drug: Risedronate
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Primary Outcome(s)
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Change in Lumbar Spine BMD From Start of Trial Period III Until End of Trial Period III.
[Time Frame: 12 months]
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Secondary ID(s)
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2005-000730-20
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FP-001-IM
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U1111-1132-3246
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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