NCT00148915

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2005

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

November 8, 2016

Status Verified

November 1, 2016

Enrollment Period

2 years

First QC Date

September 6, 2005

Last Update Submit

November 4, 2016

Conditions

Osteoporosis

Keywords

Osteoporosisbisphosphonatesbone

Outcome Measures

Primary Outcomes (1)

  • 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

    Year 1

Secondary Outcomes (8)

  • Mean percent change in BMD of the proximal femur and lumbar spine according to vQCT at one year

    Year 1

  • Mean percent change of proximal femur and spine BMD according to Dual- Energy X-ray Absorptiometry (DXA) scans

    Year 1

  • Hip geometry assessed by cross-sectional dimensions of hip using vQCT

    Year 1

  • Finite element composition of hip and spine to estimate hip and spine strength

    Year 1

  • Hip geometry assessed by cross-sectional dimensions of hip using DXA

    Year 1

  • +3 more secondary outcomes

Study Arms (2)

Ibandronate

EXPERIMENTAL

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

Drug: ibandronate

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

ibandronateDRUG
Also known as: Boniva
Ibandronate
PlaceboDRUG

matching placebo

Placebo

Eligibility Criteria

Age55 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

GSK Investigational Site

Upland, California, 91786, United States

Location

GSK Investigational Site

Boulder, Colorado, 80304, United States

Location

GSK Investigational Site

Lakewood, Colorado, 80227, United States

Location

GSK Investigational Site

Miami, Florida, 33143, United States

Location

GSK Investigational Site

Miami, Florida, 33156, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30308, United States

Location

GSK Investigational Site

Decatur, Georgia, 30033, United States

Location

GSK Investigational Site

Indianapolis, Indiana, 46202, United States

Location

GSK Investigational Site

Bangor, Maine, 04401, United States

Location

GSK Investigational Site

Bathesda, Maryland, 20817, United States

Location

GSK Investigational Site

Flint, Michigan, 48532, United States

Location

GSK Investigational Site

Albuquerque, New Mexico, 87106, United States

Location

GSK Investigational Site

West Haverstraw, New York, 10993, United States

Location

GSK Investigational Site

Duncansville, Pennsylvania, 16635, United States

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Ibandronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Officials

  • HoffmannLaRoche Clinical Trials, MD

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

August 1, 2005

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

November 8, 2016

Record last verified: 2016-11

Locations

US(14)