- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00583518
STEP: Study of Imaging Techniques (ImaTx and DXA) in Postmenopausal Women With OstEoporosis Using Preotact (FP-008-ES)
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
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Roskilde, Denmark, 4000
- Nycomed
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 a female?
- Is the subject 65 years old or above?
- 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, or a lumbar spine T-score ≤ -2.5 SD and previous fragility fracture[1], with a minimum of two evaluable lumbar vertebrae?
- Does the subject have a life expectancy of > 2 years?
- 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:
- 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)?
- Has the subject received, during her lifetime, strontium, fluoride or calcitonin > 3 months in total?
- Has the subject ever been treated with teriparatide or PTH(1-84)?
- Is the subject taking any other medication known to affect bone metabolism in the opinion of the investigator?
- Has the subject ever received radiation therapy to the skeleton?
- Has the subject ever been treated for a bone malignant disease?
- 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?
- Does the subject have any known history of hypersensitivity to parathyroid hormone or any of the excipients in the drug?
- 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?
- Does the subject have a clinically significant elevation of serum alkaline phosphatase judged by the investigator?
- Does the subject have an impaired kidney function with creatinine clearance <30ml/min (indirect measurement by serum creatinine)?
- Does the subject have a severe hepatic impairment, defined as > 9 Child-Pugh score?
- Has the subject participated in a clinical trial with an Investigational Medicinal Product (IMP) during the last 30 days?
- Does the subject have a bilateral hip replacement?
All exclusion criteria must be answered "no" for a subject to participate in the trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
72 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
72 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FP-008-ES
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postmenopausal Women With Primary Osteoporosis
-
mAbxience Research S.L.Active, not recruitingPostmenopausal Women With OsteoporosisPoland, Serbia, Bulgaria, Georgia, Estonia, Hungary, Latvia, Mexico
-
Alvogen KoreaCompletedPostmenopausal Women With OsteoporosisKorea, Republic of
-
Biocon Biologics UK LtdActive, not recruitingPostmenopausal Women With OsteoporosisUnited Kingdom
-
AmgenCompletedPostmenopausal Women With OsteoporosisUnited States, Canada, Denmark, France, Germany, Italy, Belgium, Colombia, Czechia, Mexico, Poland, Russian Federation, Netherlands, Hungary, Peru, Turkey, Taiwan, Spain, Hong Kong, Austria, Slovakia, United Kingdom, South Africa, Aus... and more
-
SandozHexal AGCompletedPostmenopausal Women With OsteoporosisUnited States, Bulgaria, Czechia, Japan, Poland, Spain
-
CelltrionCompletedPostmenopausal Women With OsteoporosisEstonia
-
Warner ChilcottCompletedPostmenopausal Women With OsteoporosisSpain, Australia, Belgium, Denmark, Finland, Italy, Poland, Sweden
-
Institut za Rehabilitaciju Sokobanjska BeogradCompletedInfluence of Specifically Designed Exercise Program on Serum Matrix Metalloproteinases and Functional Status in Women With Postmenopausal OsteoporosisSerbia
-
Bio Sidus SAUnknownPostmenopausal Osteoporosis With Pathological FractureArgentina
-
Hanlim Pharm. Co., Ltd.Completed
Clinical Trials on Parathyroid hormone (PTH)
-
John P. BilezikianShire; NPS PharmaUnknownHypoparathyroidismUnited States
-
Zosano Pharma CorporationCompletedPostmenopausal OsteoporosisUnited States
-
University of PittsburghWithdrawnHyperparathyroidism | Osteoporosis | Bone Diseases, Endocrine | Hypercalcemia of MalignancyUnited States
-
The Emmes Company, LLCNational Heart, Lung, and Blood Institute (NHLBI)TerminatedStudy of Parathyroid Hormone Following Sequential Cord Blood Transplantation From an Unrelated DonorLymphoma | Hodgkin Disease | Myelofibrosis | Anemia, Aplastic | Leukemia, Lymphocytic, Acute | Leukemia, Myelocytic, Acute | Leukemia, Myeloid, Chronic | Leukemia, Lymphocytic, ChronicUnited States
-
NycomedCompletedOsteoporosis | PostmenopauseGermany
-
University of PittsburghNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National...Completed
-
ShireCompleted
-
NycomedCompleted