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A Study To Assess the Quality and Strength of Bone in Women Participants With Osteoporosis Taking Oral Ibandronate Versus Placebo

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ibandronate
Placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis focused on measuring Osteoporosis, bisphosphonates, bone

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria: Ambulatory, postmenopausal women between the age of 55 to 80 years diagnosed with osteoporosis BMD T-Score less than or equal to (<=) -2.0 at total spine or total femur or total neck, and BMD T-score greater than or equal to (>=) -5.0 at all 3 sites Exclusion criteria: Have been treated with other bisphosphonates or using chronic steroids within the past 6 months Have a history of major upper gastrointestinal (GI) diseases or have severe kidney dysfunction Have a spine fracture (identified on X-ray)

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ibandronate

Placebo

Arm Description

Participants will receive 150 milligrams (mg) ibandronate tablet orally once monthly for one year.

Participants will receive ibandronate matched placebo tablet orally once monthly for one year.

Outcomes

Primary Outcome Measures

Mean percent change in integral (cortical and trabecular bone compartments combined) hip bone mineral density (BMD) as determined by Volumetric Quantitative Computed Tomography (vQCT) at one year

Secondary Outcome Measures

Mean percent change in BMD of the proximal femur and lumbar spine according to vQCT at one year
Mean percent change of proximal femur and spine BMD according to Dual- Energy X-ray Absorptiometry (DXA) scans
Hip geometry assessed by cross-sectional dimensions of hip using vQCT
Finite element composition of hip and spine to estimate hip and spine strength
Hip geometry assessed by cross-sectional dimensions of hip using DXA
Trabecular bone dimensions by bone biopsies using histomorphometry and micro computed tomography to assess bone quality
Change from baseline for serum-C-terminal cross-linking telopeptide of Type I collagen (Serum-CTX)
Change from baseline for bone-specific alkaline phosphatase (Bone ALP)

Full Information

First Posted
September 6, 2005
Last Updated
November 4, 2016
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00148915
Brief Title
A Study To Assess the Quality and Strength of Bone in Women Participants With Osteoporosis Taking Oral Ibandronate Versus Placebo
Official Title
A One Year, Parallel, Placebo-controlled, Double-blind, Randomized Study to Assess the Effect of Monthly 150 mg Oral Ibandronate Dosing Versus Placebo on Bone Quality and Strength at the Proximal Femur in Women With Osteoporosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this randomized, double-blind, placebo-controlled study is to estimate the effect of oral ibandronate sodium (Boniva) taken once monthly versus placebo on bone quality and strength at the proximal femur at one year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Osteoporosis, bisphosphonates, bone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ibandronate
Arm Type
Experimental
Arm Description
Participants will receive 150 milligrams (mg) ibandronate tablet orally once monthly for one year.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive ibandronate matched placebo tablet orally once monthly for one year.
Intervention Type
Drug
Intervention Name(s)
ibandronate
Other Intervention Name(s)
Boniva
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
matching placebo
Primary Outcome Measure Information:
Title
Mean percent change in integral (cortical and trabecular bone compartments combined) hip bone mineral density (BMD) as determined by Volumetric Quantitative Computed Tomography (vQCT) at one year
Time Frame
Year 1
Secondary Outcome Measure Information:
Title
Mean percent change in BMD of the proximal femur and lumbar spine according to vQCT at one year
Time Frame
Year 1
Title
Mean percent change of proximal femur and spine BMD according to Dual- Energy X-ray Absorptiometry (DXA) scans
Time Frame
Year 1
Title
Hip geometry assessed by cross-sectional dimensions of hip using vQCT
Time Frame
Year 1
Title
Finite element composition of hip and spine to estimate hip and spine strength
Time Frame
Year 1
Title
Hip geometry assessed by cross-sectional dimensions of hip using DXA
Time Frame
Year 1
Title
Trabecular bone dimensions by bone biopsies using histomorphometry and micro computed tomography to assess bone quality
Time Frame
Year 1
Title
Change from baseline for serum-C-terminal cross-linking telopeptide of Type I collagen (Serum-CTX)
Time Frame
Months 3, 6, 9, and 12
Title
Change from baseline for bone-specific alkaline phosphatase (Bone ALP)
Time Frame
Months 3, 6, 9, and 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Ambulatory, postmenopausal women between the age of 55 to 80 years diagnosed with osteoporosis BMD T-Score less than or equal to (<=) -2.0 at total spine or total femur or total neck, and BMD T-score greater than or equal to (>=) -5.0 at all 3 sites Exclusion criteria: Have been treated with other bisphosphonates or using chronic steroids within the past 6 months Have a history of major upper gastrointestinal (GI) diseases or have severe kidney dysfunction Have a spine fracture (identified on X-ray)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HoffmannLaRoche Clinical Trials, MD
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
GSK Investigational Site
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
GSK Investigational Site
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80227
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
GSK Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
GSK Investigational Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
GSK Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
GSK Investigational Site
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
GSK Investigational Site
City
Bathesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
GSK Investigational Site
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
GSK Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
GSK Investigational Site
City
West Haverstraw
State/Province
New York
ZIP/Postal Code
10993
Country
United States
Facility Name
GSK Investigational Site
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States

12. IPD Sharing Statement

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A Study To Assess the Quality and Strength of Bone in Women Participants With Osteoporosis Taking Oral Ibandronate Versus Placebo

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