A Transiliac Crest Bone Histology and Histomorphometry Study in Postmenopausal Women with Low Bone Mass or Osteoporosis Previously Treated with Denosumab
Study Details
To characterize the effects of discontinuation of denosumab therapy on variables of bone histology in postmenopausal women with low bone mass or osteoporosis. Patients who have 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) will be included in this study. Patients who will participate in the off-treatment imaging study for 20080747 (NCT00890981) are also eligible.
Protocol Summary
Number of participants with normal/abnormal bone histology
Timeframe: 25-34 days post-Day 1
Bone histomorphometry: Cancellous bone volume
Timeframe: 25-34 days post-Day 1
Bone histomorphometry: Trabecular number
Timeframe: 25-34 days post-Day 1
Bone histomorphometry: Trabecular Separation
Timeframe: 25-34 days post-Day 1
Bone histomorphometry: Trabecular thickness
Timeframe: 25-34 days post-Day 1
Bone histomorphometry: Cortical width
Timeframe: 25-34 days post-Day 1
Bone histomorphometry: Surface density
Timeframe: 25-34 days post-Day 1
Bone histomorphometry: Osteoblast - osteoid interface
Timeframe: 25-34 days post-Day 1
Bone histomorphometry: Osteoid surface
Timeframe: 25-34 days post-Day 1
Bone histomorphometry: Osteoid width
Timeframe: 25-34 days post-Day 1
Bone histomorphometry: Wall thickness
Timeframe: 25-34 days post-Day 1
Bone histomorphometry: Eroded surface/bone surface
Timeframe: 25-34 days post-Day 1
Bone histomorphometry: Osteoclast number - length based
Timeframe: 25-34 days post-Day 1
Bone histomorphometry: Osteoclast number - surface based
Timeframe: 25-34 days post-Day 1
Bone histomorphometry: Single-label surface
Timeframe: 25-34 days post-Day 1
Bone histomorphometry: Double-label surface
Timeframe: 25-34 days post-Day 1
Bone histomorphometry: Total mineralizing surface
Timeframe: 25-34 days post-Day 1
Bone histomorphometry: Mineral apposition rate
Timeframe: 25-34 days post-Day 1
Bone histomorphometry: Adjusted Mineral apposition rate
Timeframe: 25-34 days post-Day 1
Bone histomorphometry: Bone formation rate - surface based
Timeframe: 25-34 days post-Day 1
Bone histomorphometry: Bone formation rate - volume based
Timeframe: 25-34 days post-Day 1
Bone histomorphometry: Formation period
Timeframe: 25-34 days post-Day 1
Bone histomorphometry: Activation frequency
Timeframe: 25-34 days post-Day 1
Bone histomorphometry: Osteoid volume
Timeframe: 25-34 days post-Day 1
Bone histomorphometry: Mineralization lag time
Timeframe: 25-34 days post-Day 1
C-Telopeptide (CTX-1)
Timeframe: Day 3 or Day 20
Procollagen Type 1 N-terminal Peptide (P1NP)
Timeframe: Day 3 or Day 20