NCT00887965

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Amgen · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Low Bone Mass
• Low Bone Mineral Density
• Osteoporosis
• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	Previous denosumab	Participants who had previously received denosumab received a transiliac crest bone biopsy performed following standard labeling procedures with tetracycline or tetracycline derivative.

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-06-01
• Completion: 2010-08-01
• First posted: 2009-04-24
• Last updated: 2013-11-15
• Results posted: 2013-10-17