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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nycomed
ClinicalTrials.gov Identifier:
NCT00583518
First received: December 20, 2007
Last updated: May 4, 2012
Last verified: May 2012
  Purpose

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).


Condition Intervention Phase
Postmenopausal Women With Primary Osteoporosis
Drug: Parathyroid hormone (PTH)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label, Multi-centre, Longitudinal, Prospective, Phase IV Clinical Trial to Compare Two Image Technologies (ImaTx and DXA) Assessing the Anabolic Effects of PTH(1-84) in Postmenopausal Women With Primary Osteoporosis

Resource links provided by NLM:


Further study details as provided by Nycomed:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 129
Study Start Date: November 2007
Study Completion Date: February 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Parathyroid hormone (PTH)
    Postmenopausal women with primary osteoporosis
    Other Name: Preotact
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00583518

Locations
Denmark
Nycomed
Roskilde, Denmark, 4000
Sponsors and Collaborators
Nycomed
Investigators
Study Chair: Nycomed Clinical Trial Operations Headquaters
  More Information

No publications provided

Responsible Party: Nycomed
ClinicalTrials.gov Identifier: NCT00583518     History of Changes
Other Study ID Numbers: FP-008-ES
Study First Received: December 20, 2007
Last Updated: May 4, 2012
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014