Sequential Treatment of Postmenopausal Women With Primary Osteoporosis (FP-001-IM)
PEAK
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.
3 other identifiers
interventional
407
1 country
1
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 months treatment with risedronate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2006
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 9, 2006
CompletedFirst Posted
Study publicly available on registry
August 17, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
July 20, 2012
CompletedAugust 20, 2012
August 1, 2012
4.5 years
August 9, 2006
May 4, 2012
August 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Lumbar Spine BMD From Start of Trial Period III Until End of Trial Period III.
BMD was measured by Dual X-ray Absorptiometry (DXA).
12 months
Study Arms (2)
PTH (1-84)
EXPERIMENTALRisedronate
ACTIVE COMPARATORInterventions
Self-administered (100 μg in a volume of 71.4 μL) daily as a subcutaneous injection in the abdomen using the Preotact pen.
Eligibility Criteria
You may not qualify if:
- 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)?
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (1)
Unknown Facility
Roskilde, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Operations
- Organization
- Nycomed
Study Officials
- STUDY CHAIR
Nycomed Clinical Trial Operations
Headquaters
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2006
First Posted
August 17, 2006
Study Start
July 1, 2006
Primary Completion
January 1, 2011
Study Completion
August 1, 2011
Last Updated
August 20, 2012
Results First Posted
July 20, 2012
Record last verified: 2012-08