NCT00386360

Study of the Effect of Once a Week Risedronate on the Microstructure of Tibia and Radius Using a New Scanning Method

A Non-Invasive Evaluation of Bone Microarchitecture Modification in Osteopenic Postmenopausal Women by 3D-Peripheral Quantitative Computed Tomography (3D-pQCT)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: Female
• Age: 40 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of the protocol is to evaluate the sensitivity of 3D-pQCT (3D-Peripheral Quantitative Computed Tomography) technology to detect minute changes in bone microarchitecture.

Detailed description

The 3D-pQCT equipment allows the evaluation of changes occurring within the bone at "microarchitecture" level, without the need for invasive bone biopsies. The primary objective is to evaluate the sensitivity of the technology to detect a difference between those treated with risedronate 35mg OAW (once a week) or placebo. Early phase postmenopausal women with osteopenia have been chosen because they have a more rapid and higher level of bone loss during the first few years of the menopause.

Conditions

• Osteopenia

Interventions

Type	Name	Description
DRUG	Placebo comparator	oral weekly for one year
DRUG	risedronate	35 mg risedronate, once a week for one year

Timeline

• Start date: 2006-04-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2006-10-11
• Last updated: 2012-01-11
• Results posted: 2012-01-11

Locations

9 sites across 7 countries: Argentina, Australia, Canada, France, Germany, Switzerland, United Kingdom