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)

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.

Study Overview

• Status: Completed
• Conditions: Osteopenia
• Intervention / Treatment: Drug: Placebo comparator; Drug: risedronate

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.

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1012AAR
    • Research Facility
• Australia
  • Victoria
    • Heidelberg, Victoria, Australia, 3081
      • Research Facility
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Research Facility
• France
  • Lyon, France
    • Research Facility
  • Saint-Etienne, France
    • Research Facility
  • Toulouse, France
    • Research Facility
• Germany
  • Berlin, Germany
    • Research Facility
• Switzerland
  • Geneva, Switzerland
    • Research Facility
• United Kingdom
  • Cambridge, United Kingdom
    • Research Facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo dose	Drug: Placebo comparator; oral weekly for one year
Experimental: Risedronate; 35 mg risedronate, orally, once weekly	Drug: risedronate; 35 mg risedronate, once a week for one year

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Trabecular Bone Volume to Tissue Volume at Distal Radius, Percent Change From Baseline to Month 12	Baseline and Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Bone Density at Distal Radius, Percent Change From Baseline to Month 12		Baseline and Month 12
Compact Bone Density at Distal Radius, Percent Change From Baseline to Month 12		Baseline and Month 12
Trabecular Bone Density at Distal Radius, Percent Change From Baseline to Month 12		Baseline and Month 12
Average Bone Density at Distal Tibia, Percent Change From Baseline to Month 12		Baseline and Month 12
Compact Bone Density at Distal Tibia, Percent Change From Baseline to Month 12		Baseline and Month 12
Trabecular Bone Density at Distal Tibia, Percent Change From Baseline to Month 12		Baseline and Month 12
Lumbar Spine BMD, Percent Change From Baseline to Month 12		Baseline and Month 12
Total Proximal Femur BMD (Bone Mineral Density), Percent Change From Baseline to Month 12		Baseline and Month 12
Femoral Neck BMD, Percent Change From Baseline to Month 12		Baseline and Month 12
Greater Trochanter BMD, Percent Change From Baseline to Month 12		Baseline and Month 12
Type I Collagen C-Telopeptides, Serum, Percent Change From Baseline to Month 12	ELISA / enzyme-linked immunosorbent assay method by central lab	Baseline and Month 12
Procollagen Type 1 N-Propeptide, Percent Change From Baseline to Month 12	Electrochemiluminescence assay method by central lab	Baseline and Month 12
Height, Percent Change From Baseline to Month 12		Baseline and Month 12

Collaborators and Investigators

• Sponsor: Warner Chilcott
• Investigators: Principal Investigator: Gioacchino D'Alo, MD, P&G Pharmaceuticals, Clinical Development Europe

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: October 9, 2006
• First Submitted That Met QC Criteria: October 10, 2006
• First Posted (Estimate): October 11, 2006

Study Record Updates

• Last Update Posted (Estimate): January 11, 2012
• Last Update Submitted That Met QC Criteria: December 6, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Risedronic Acid
• Other Study ID Numbers: 2005040