A Study To Assess The Quality Of Bone In Patients Taking Oral Ibandronate Versus Placebo

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT02948881

Collaborator

(none)

100

Enrollment

Locations

Duration (Months)

6.7

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to estimate the effect of oral Boniva (ibandronate sodium)taken once monthly versus placebo on bone quality and strength at the hip at one year.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Drug: ibandronate	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A One Year, Parallel, Placebo-controlled, Double-blind, Randomized Study to Assess the Effect of Monthly 150mg Oral Ibandronate Dosing Versus Placebo on Bone Quality and Strength at the Proximal Femur in Women With Osteoporosis

Study Start Date :

Aug 1, 2005

Actual Primary Completion Date :

Jul 1, 2007

Actual Study Completion Date :

Jul 1, 2007

Outcome Measures

Primary Outcome Measures

Bone quality and strength at the hip by characterizing changes in trabecular and cortical bone quality using Volumetric Quantitative Computed Tomography (vQCT) and novel imaging analysis methods, including a subset of bone biopsies for one year. [1 Year]

Secondary Outcome Measures

Relationship between biomarkers and changes in bone quality for one year. [1 Year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion criteria:

Ambulatory, postmenopausal women who are diagnosed with osteoporosis.
Must be able to stand or sit upright for at least 60 minutes and swallow a tablet whole.

Exclusion criteria:

Have been treated with other bisphosphonates or using chronic steroids within the past 6 months.
Have a history of major upper GI diseases or have severe kidney dysfunction.
Have a spine fracture (identified on x-ray).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Upland	California	United States	91786
2	GSK Investigational Site	Boulder	Colorado	United States	80304
3	GSK Investigational Site	Lakewood	Colorado	United States	80227
4	GSK Investigational Site	Miami	Florida	United States	33143
5	GSK Investigational Site	Miami	Florida	United States	33156
6	GSK Investigational Site	West Palm Beach	Florida	United States	33407
7	GSK Investigational Site	Atlanta	Georgia	United States	30308
8	GSK Investigational Site	Decatur	Georgia	United States	30033
9	GSK Investigational Site	Indianapolis	Indiana	United States	46202
10	GSK Investigational Site	Bangor	Maine	United States	04401
11	GSK Investigational Site	Bathesda	Maryland	United States	20817
12	GSK Investigational Site	Flint	Michigan	United States	48532
13	GSK Investigational Site	Albuquerque	New Mexico	United States	87106
14	GSK Investigational Site	West Haverstraw	New York	United States	10993
15	GSK Investigational Site	Duncansville	Pennsylvania	United States	16635