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

NCT ID: NCT00386360

Last Updated: 2012-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 161 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2009-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo dose

Group Type: PLACEBO_COMPARATOR

Placebo comparator

Intervention Type: DRUG

oral weekly for one year

Risedronate

35 mg risedronate, orally, once weekly

Group Type: EXPERIMENTAL

risedronate

Intervention Type: DRUG

35 mg risedronate, once a week for one year

Interventions

Placebo comparator

oral weekly for one year

Intervention Type: DRUG

risedronate

35 mg risedronate, once a week for one year

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• cessation of menstruation (surgical or natural) between 6 and 36 months prior to study enrollment;
• osteopenic
• must have at least 1 evaluable radius and tibia, without history of fracture (traumatic or atraumatic)
• BMI (body mass index) between 18 and 28 kg/m2 inclusive;

Exclusion Criteria

• history of any generalized bone disease, including hyperparathyroidism, Paget's disease of bone, renal osteodystrophy, or any other acquired or congenital bone disease; or any known condition that would interfere with the assessment of DXA (dual-energy X-ray absorptiometry) at either the lumbar spine (3 non-evaluable lumbar vertebrae at lumbar spine L1 - L4) or the femoral neck.
• clinical or radiological evidence of osteoporosis, such as atraumatic vertebral compression fracture (* 20% reduction in anterior-to-posterior or middle-to-posterior height ratio; or 20% reduction of the anterior, middle, and/or posterior height as compared with the adjacent vertebrae) documented by spinal X ray or a history of osteoporosis-related atraumatic fracture of the hip or of the wrist;
• glucocorticoid-induced osteopenia;
• previous bisphosphonate therapy;

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Warner Chilcott

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gioacchino D'Alo, MD

Role: PRINCIPAL_INVESTIGATOR

P&G Pharmaceuticals, Clinical Development Europe

Locations

Research Facility

Buenos Aires, Buenos Aires, Argentina

Research Facility

Heidelberg, Victoria, Australia

Research Facility

Toronto, Ontario, Canada

Research Facility

Lyon, Lyon, France

Research Facility

Saint-Etienne, Saint-Etienne, France

Research Facility

Toulouse, Toulouse, France

Research Facility

Berlin, State of Berlin, Germany

Research Facility

Geneva, Canton of Geneva, Switzerland

Research Facility

Cambridge, Cambridge, United Kingdom

Countries

Argentina; Australia; Canada; France; Germany; Switzerland; United Kingdom

Other Identifiers

2005040

Identifier Type: -

Identifier Source: org_study_id