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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parathyroid hormone (PTH) | Drug | Postmenopausal women with primary osteoporosis |
|
| Measure | Description | 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 | 72 weeks |
| Measure | Description | 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 (%). | 72 weeks |
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Inclusion Criteria:
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:
All exclusion criteria must be answered "no" for a subject to participate in the trial.
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| Name | Affiliation | Role |
|---|---|---|
| Nycomed Clinical Trial Operations | Headquaters | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nycomed | Roskilde | 4000 | Denmark |
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| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| ID | Term |
|---|---|
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
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| D000602 | Amino Acids, Peptides, and Proteins |