Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Previous denosumab · 1 trial · 4 indications
The number of participants with normal/abnormal bone histology as assessed by bone biopsy samples at the central histomorphometric facility. Normal bone histology is characterized by: - normal lamellar bone, - normal mineralization or - osteoid (the organic matrix of bone; young bone that has not undergone calcification). Biopsies with abnormal bone histology are characterized by: - osteomalacia, - marrow fibrosis, - clinically significant marrow abnormality or - woven bone.
| Arm | Type | Description |
|---|---|---|
| Previous denosumab | OTHER | Participants who had previously received denosumab received a transiliac crest bone biopsy performed following standard labeling procedures with tetracycline or tetracycline derivative. |
| Name | Type | Description |
|---|---|---|
| Previous denosumab | DRUG | Participants who had previously received denosumab received a transiliac crest bone biopsy performed following standard labeling procedures with tetracycline or tetracycline derivative. |
Inclusion Criteria: * Ambulatory postmenopausal women * Received denosumab and completed study 20050179 (NCT00293813), completed study 20050141 (NCT00330460), completed study 20060237 (NCT00515463), completed study 20030216 (NCT00089791) but did not enroll in study 20060289 (NCT00523341). Patients ...
Previous denosumab is an investigational monoclonal antibody developed by Amgen Inc. (ticker AMGN) for low bone mass. It has been studied in postmenopausal women with low bone mass or osteoporosis who were previously treated with denosumab. The program is in Phase 2 clinical development.
Previous denosumab is being studied for low bone mass, including low bone mineral density and postmenopausal osteoporosis. Its clinical work has focused on postmenopausal women who had prior denosumab treatment. It is an investigational therapy and is not an approved product for these uses.
Previous denosumab is developed by Amgen Inc., which trades under the ticker AMGN. Amgen is the sponsor behind the clinical program evaluating the monoclonal antibody in postmenopausal women with low bone mass or osteoporosis who were previously treated with denosumab.
Previous denosumab is in Phase 2 clinical development. It is an investigational monoclonal antibody and is not approved by the FDA. The Phase 2 program has completed its single registered trial, and no trials are currently active.
Previous denosumab has been evaluated in one completed Phase 2 trial, NCT00887965, titled A Transiliac Crest Bone Histology and Histomorphometry Study in Postmenopausal Women With Low Bone Mass or Osteoporosis Previously Treated With Denosumab. The trial enrolled 15 female participants, was uncontrolled, and is now completed.