Status:
COMPLETED
Sequential Treatment of Postmenopausal Women With Primary Osteoporosis (FP-001-IM)
Lead Sponsor:
Takeda
Conditions:
Osteoporosis
Eligibility:
FEMALE
50+ years
Phase:
PHASE3
Brief Summary
The objective is to show superior efficacy of PTH (1-84) over risedronate in treating osteoporotic women for 12 months after having previously been treated with PTH (1-84) for 12 months followed by 12...
Eligibility Criteria
Inclusion
- 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.
- 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).
- Is the subject above 50 years old?
- Is the subject postmenopausal (more than 5 years) - in the judgement of the investigator?
- 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)?
- Does the subject have a life expectancy of \>3 years?
- Is the subject able to self-inject PTH (1-84), (or to have PTH (1-84) injection by a helper)?
Exclusion
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
407 Patients enrolled
Trial Details
Trial ID
NCT00365456
Start Date
July 1 2006
End Date
August 1 2011
Last Update
August 20 2012
Active Locations (1)
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1
Roskilde, Denmark