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

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT00148915

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

98 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Aug 1, 2005

Actual Primary Completion Date :

Aug 1, 2007

Actual Study Completion Date :

Aug 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ibandronate Participants will receive 150 milligrams (mg) ibandronate tablet orally once monthly for one year.	Drug: ibandronate Other Names: Boniva
Placebo Comparator: Placebo Participants will receive ibandronate matched placebo tablet orally once monthly for one year.	Drug: Placebo matching placebo

Arm

Intervention/Treatment

Experimental: Ibandronate

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

Drug: ibandronate

Other Names:

Boniva

Placebo Comparator: Placebo

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

Drug: Placebo

matching placebo

Outcome Measures

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 [Year 1]

Secondary Outcome Measures

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]
Trabecular bone dimensions by bone biopsies using histomorphometry and micro computed tomography to assess bone quality [Year 1]
Change from baseline for serum-C-terminal cross-linking telopeptide of Type I collagen (Serum-CTX) [Months 3, 6, 9, and 12]
Change from baseline for bone-specific alkaline phosphatase (Bone ALP) [Months 3, 6, 9, and 12]

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 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)

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	Atlanta	Georgia	United States	30308
7	GSK Investigational Site	Decatur	Georgia	United States	30033
8	GSK Investigational Site	Indianapolis	Indiana	United States	46202
9	GSK Investigational Site	Bangor	Maine	United States	04401
10	GSK Investigational Site	Bathesda	Maryland	United States	20817
11	GSK Investigational Site	Flint	Michigan	United States	48532
12	GSK Investigational Site	Albuquerque	New Mexico	United States	87106
13	GSK Investigational Site	West Haverstraw	New York	United States	10993
14	GSK Investigational Site	Duncansville	Pennsylvania	United States	16635