NCT00890981

A High-resolution Peripheral Quantitative Computed Tomography Study in Postmenopausal Women Previously Treated With Denosumab

A HR-pQCT Study in Postmenopausal Women Previously Treated With Denosumab

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Amgen · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

To evaluate the combined effect of denosumab treatment and discontinuation on cortical thickness at the distal radius by High Resolution-Peripheral Quantitative Computed Tomography (HR-pQCT). Participants randomized to either denosumab or placebo in the 20050179 (NCT00293813) study who completed that study (ie, attended an end of study visit) can be included in this study. At least 12 months should have elapsed since the patient's 20050179 end of study visit.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	high-resolution peripheral quantitative computed tomography (HR-pQCT)	Bone densitometry and microarchitecture assessments of the distal radius and the distal tibia by HR-pQCT on Day 1.
PROCEDURE	Dual energy X-ray absorptiometry (DXA)	Bone densitometry assessments of the forearm by DXA on day 1.
BIOLOGICAL	Denosumab	Denosumab 60 mg subcutaneously every 6 months in the previous study
DRUG	Placebo	Placebo to denosumab subcutaneously every 6 months in the previous study

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-06-01
• Completion: 2010-08-01
• First posted: 2009-04-30
• Last updated: 2014-04-02
• Results posted: 2011-07-28