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 ...
Denosumab is used for low bone mass, low bone mineral density, osteoporosis, and postmenopausal osteoporosis. It is being studied in postmenopausal women with these conditions. The drug is currently in Phase 2 clinical development.
Denosumab is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. Amgen is conducting clinical trials to evaluate the drug's effects in patients with low bone mass and related bone conditions.
Denosumab is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in a completed Phase 2 trial involving postmenopausal women with low bone mass or osteoporosis.
Denosumab has one completed clinical trial, NCT00887965, titled "A Transiliac Crest Bone Histology and Histomorphometry Study in Postmenopausal Women With Low Bone Mass or Osteoporosis Previously Treated With Denosumab." This Phase 2 study enrolled 15 female participants and was not randomized or blinded.
Denosumab is the generic name for the drug also known as Prolia. The clinical trial NCT00887965 studied postmenopausal women previously treated with denosumab, and the drug is being developed by Amgen Inc. for bone-related conditions.