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Trial · Interventional

CompletedPhase 4Registry data

STEP: 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
2007200820092010201120122013
  1. Ph 4

    STEP: Study of Imaging Techniques (ImaTx and DXA) in Postmenopausal Women With OstEoporosis Using Preotact (FP-008-ES)

    NCT00583518

    Nov 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.

  1. 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)
  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
Inclusion Criteria: 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 a female? 3. Is the subject 65 years old or above? 4. Is the subject postmenopausal (more than 5 years), in the judgement of the investigator? 5. Does the subject have primary osteoporosis, with a lumbar spine T score ≤ -3.0 SD, or a lumbar spine T-score ≤ -2.5 SD and previous fragility fracture\[1\], with a minimum of two evaluable lumbar vertebrae? 6. Does the subject have a life expectancy of \> 2 years? 7. Does the subject have a clinical indication to receive PTH(1-84) and is able to self-inject (or to have PTH(1-84) injection by a helper)? All inclusion criteria must be answered "yes" for a subject to participate in the trial. \[1\] Definition of fragility fracture in the scope of the study: Bone fractures that occur as a result of a fall from standing height or less. That is, fractures resulting from mechanical forces that would not ordinarily cause fractures in a healthy person. Exclusion Criteria: 1. Is the patient currently taking any of the following treatments: bisphosphonates, selective estrogen receptor modulators or hormone replacement therapy (if the patient discontinues any of these treatments at the screening visit, the question can be answered NO and the patient can be included)? 2. Has the subject received, during her lifetime, strontium, fluoride or calcitonin \> 3 months in total? 3. Has the subject ever been treated with teriparatide or PTH(1-84)? 4. Is the subject taking any other medication known to affect bone metabolism in the opinion of the investigator? 5. Has the subject ever received radiation therapy to the skeleton? 6. Has the subject ever been treated for a bone malignant disease? 7. Is the subject suffering from any known clinically significant diseases affecting calcium metabolism, including metabolic bone diseases such as hyperparathyroidism, Paget's disease, osteogenesis imperfecta, or osteomalacia? 8. Does the subject have any known history of hypersensitivity to parathyroid hormone or any of the excipients in the drug? 9. Does the subject have an elevated serum calcium (total serum calcium value \>10.2 mg/dl) after at least 14 days of a 1000 mg calcium and 800 IU vitamin D3 supplementation? 10. Does the subject have a clinically significant elevation of serum alkaline phosphatase judged by the investigator? 11. Does the subject have an impaired kidney function with creatinine clearance \<30ml/min (indirect measurement by serum creatinine)? 12. Does the subject have a severe hepatic impairment, defined as \> 9 Child-Pugh score? 13. Has the subject participated in a clinical trial with an Investigational Medicinal Product (IMP) during the last 30 days? 14. Does the subject have a bilateral hip replacement? All exclusion criteria must be answered "no" for a subject to participate in the trial.

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