Trial · Interventional
CompletedPhase 4Registry dataSTEP: Study of Imaging Techniques (ImaTx and DXA) in Postmenopausal Women With OstEoporosis Using Preotact (FP-008-ES)
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 129 participants (actual)
- Sponsor
- Nycomed · Industry
- Design
- Not randomized · Open label (no masking)
- Countries
1 country
Denmark
- Start
- Nov 2007
- Primary completion
- Nov 2011
- Completion
- Feb 2012
- First posted
- 31 Dec 2007 (estimated)
- Last update posted
- 7 May 2012 (estimated)
- Conditions
- Postmenopausal Women With Primary Osteoporosis
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
STEP: Study of Imaging Techniques (ImaTx and DXA) in Postmenopausal Women With OstEoporosis Using Preotact (FP-008-ES)
NCT00583518Nov 2007 to Feb 2012
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The primary objective of the study is to explore the relationship between a new image technology (ImaTx), that analyzes the trabecular structure of the bone using digitized radiographs and the bone mineral density (BMD) measured by Dual X-ray Absorptiometry (DXA) in the lumbar spine of postmenopausal (PM) women with osteoporosis (OP) after treatment with PTH (1-84).
Interventions
- Parathyroid hormone (PTH)Drug
Arms0
The registry lists no arms for this trial.
Primary outcomes1
Outcomes the sponsor listed as primary.
Correlation coefficient between the percentage of increase in Bone Mineral Density (BMD) obtained by DXA in the lumbar spine and in Trabecular Fragment Length (TFL) obtained by ImaTx in digitised radiographs of lumbar spine from baseline to EOT
Time frame · 72 weeks
Secondary outcomes(1)
BMD obtained by DXA in the lumbar spine (DXA SPI BMD). Two measurements will be determined: Mean value (g/cm2) and percentage of increase at EOT versus baseline (%).
Time frame · 72 weeks
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
PepBank is a research reference. Talk to a doctor before you use any peptide.