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

Primary Purpose

Osteopenia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo comparator
risedronate
Sponsored by
Warner Chilcott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteopenia

Eligibility Criteria

40 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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;

Sites / Locations

  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility
  • Research Facility

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Risedronate

Arm Description

Placebo dose

35 mg risedronate, orally, once weekly

Outcomes

Primary Outcome Measures

Trabecular Bone Volume to Tissue Volume at Distal Radius, Percent Change From Baseline to Month 12

Secondary Outcome Measures

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

Full Information

First Posted
October 9, 2006
Last Updated
December 6, 2011
Sponsor
Warner Chilcott
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1. Study Identification

Unique Protocol Identification Number
NCT00386360
Brief Title
Study of the Effect of Once a Week Risedronate on the Microstructure of Tibia and Radius Using a New Scanning Method
Official Title
A Non-Invasive Evaluation of Bone Microarchitecture Modification in Osteopenic Postmenopausal Women by 3D-Peripheral Quantitative Computed Tomography (3D-pQCT)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Warner Chilcott

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
161 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo dose
Arm Title
Risedronate
Arm Type
Experimental
Arm Description
35 mg risedronate, orally, once weekly
Intervention Type
Drug
Intervention Name(s)
Placebo comparator
Intervention Description
oral weekly for one year
Intervention Type
Drug
Intervention Name(s)
risedronate
Intervention Description
35 mg risedronate, once a week for one year
Primary Outcome Measure Information:
Title
Trabecular Bone Volume to Tissue Volume at Distal Radius, Percent Change From Baseline to Month 12
Time Frame
Baseline and Month 12
Secondary Outcome Measure Information:
Title
Average Bone Density at Distal Radius, Percent Change From Baseline to Month 12
Time Frame
Baseline and Month 12
Title
Compact Bone Density at Distal Radius, Percent Change From Baseline to Month 12
Time Frame
Baseline and Month 12
Title
Trabecular Bone Density at Distal Radius, Percent Change From Baseline to Month 12
Time Frame
Baseline and Month 12
Title
Average Bone Density at Distal Tibia, Percent Change From Baseline to Month 12
Time Frame
Baseline and Month 12
Title
Compact Bone Density at Distal Tibia, Percent Change From Baseline to Month 12
Time Frame
Baseline and Month 12
Title
Trabecular Bone Density at Distal Tibia, Percent Change From Baseline to Month 12
Time Frame
Baseline and Month 12
Title
Lumbar Spine BMD, Percent Change From Baseline to Month 12
Time Frame
Baseline and Month 12
Title
Total Proximal Femur BMD (Bone Mineral Density), Percent Change From Baseline to Month 12
Time Frame
Baseline and Month 12
Title
Femoral Neck BMD, Percent Change From Baseline to Month 12
Time Frame
Baseline and Month 12
Title
Greater Trochanter BMD, Percent Change From Baseline to Month 12
Time Frame
Baseline and Month 12
Title
Type I Collagen C-Telopeptides, Serum, Percent Change From Baseline to Month 12
Description
ELISA / enzyme-linked immunosorbent assay method by central lab
Time Frame
Baseline and Month 12
Title
Procollagen Type 1 N-Propeptide, Percent Change From Baseline to Month 12
Description
Electrochemiluminescence assay method by central lab
Time Frame
Baseline and Month 12
Title
Height, Percent Change From Baseline to Month 12
Time Frame
Baseline and Month 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gioacchino D'Alo, MD
Organizational Affiliation
P&G Pharmaceuticals, Clinical Development Europe
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Facility
City
Buenos Aires
ZIP/Postal Code
C1012AAR
Country
Argentina
Facility Name
Research Facility
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
Research Facility
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Research Facility
City
Lyon
Country
France
Facility Name
Research Facility
City
Saint-Etienne
Country
France
Facility Name
Research Facility
City
Toulouse
Country
France
Facility Name
Research Facility
City
Berlin
Country
Germany
Facility Name
Research Facility
City
Geneva
Country
Switzerland
Facility Name
Research Facility
City
Cambridge
Country
United Kingdom

12. IPD Sharing Statement

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

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