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| Sponsor: | Amgen |
|---|---|
| Information provided by: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00887965 |
Purpose
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 |
|---|---|---|
|
Low Bone Mass Low Bone Mineral Density Osteoporosis Postmenopausal Osteoporosis |
Procedure: Bone Biopsy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | A Transiliac Crest Bone Histology and Histomorphometry Study in Postmenopausal Women With Low Bone Mass or Osteoporosis Previously Treated With Denosumab |
| Enrollment: | 15 |
| Study Start Date: | June 2009 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Arm 1 |
Procedure: Bone Biopsy
A transiliac crest bone biopsy will be performed following standard labeling procedures with tetracycline (or tetracycline derivative)
|
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00887965 History of Changes |
| Other Study ID Numbers: | 20080287 |
| Study First Received: | April 23, 2009 |
| Last Updated: | January 20, 2011 |
| 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 |
|
Osteoporosis Osteoporosis, Postmenopausal Marfan Syndrome Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Bone Diseases, Developmental Heart Defects, Congenital |
Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Abnormalities, Multiple Congenital Abnormalities Genetic Diseases, Inborn Connective Tissue Diseases |