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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00887965 |
To characterize the effects of discontinuation of denosumab therapy on variables of bone histology in postmenopausal women with low bone mass or osteoporosis. Subjects who have received denosumab and completed study 20050179, completed study 20050141, completed study 20060237, completed study 20030216 but did not enroll in study 20060289 will be included in this study. Subjects who will participate in the off-treatment imaging study for 20080747 are also eligible.
Condition | Intervention | Phase |
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Low Bone Mass Low Bone Mineral Density Osteoporosis Postmenopausal Osteoporosis |
Procedure: Bone Biopsy |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Open Label, Single Group Assignment, Safety Study |
Official Title: | A Transiliac Crest Bone Histology and Histomorphometry Study in Postmenopausal Women With Low Bone Mass or Osteoporosis Previously Treated With Denosumab |
Estimated Enrollment: | 15 |
Study Start Date: | June 2009 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1 |
Procedure: Bone Biopsy
A transiliac crest bone biopsy will be performed following standard labeling procedures with tetracycline (or tetracycline derivative)
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Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20080287 |
Study First Received: | April 23, 2009 |
Last Updated: | April 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00887965 History of Changes |
Health Authority: | Argentina: ANMAT (Administracion Nacional de Medicamentos Alimentos y Tecnologia Medica); Argentina: Ministry of Health; Canada: Health Canada; United States: Food and Drug Administration |
Low Bone Mass Low Bone Mineral Density Osteoporosis Postmenopausal Osteoporosis |
Bone Biopsy Transiliac Crest Bone Histology Histomorphometry |
Musculoskeletal Diseases Osteoporosis, Postmenopausal Osteoporosis |
Bone Diseases, Metabolic Tetracycline Bone Diseases |
Musculoskeletal Diseases Osteoporosis, Postmenopausal Osteoporosis Bone Diseases, Metabolic Bone Diseases |