Study Complete
Sponsor ID
20080287

A Transiliac Crest Bone Histology and Histomorphometry Study in Postmenopausal Women with Low Bone Mass or Osteoporosis Previously Treated with Denosumab

Sponsor ID
20080287
Clinicaltrials.gov ID
NCT00887965
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 2
Product
denosumab
Type
Interventional
Masking
None (Open Label)
Enrollment
15
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of participants with normal/abnormal bone histology

Timeframe: 25-34 days post-Day 1

Secondary Outcome Measures

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

Study Documents

Study Synopsis
Available Language(s): English

Locations

No locations found.