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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02948881
• Other study ID #: BON103593
• Status: Completed
• Phase: Phase 4
• First received: October 27, 2016
• Last updated: October 27, 2016
• Start date: August 2005
• Est. completion date: July 2007

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years to 80 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• ibandronate

Locations

Country	Name	City	State
United States	GSK Investigational Site	Albuquerque	New Mexico
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Bangor	Maine
United States	GSK Investigational Site	Bathesda	Maryland
United States	GSK Investigational Site	Boulder	Colorado
United States	GSK Investigational Site	Decatur	Georgia
United States	GSK Investigational Site	Duncansville	Pennsylvania
United States	GSK Investigational Site	Flint	Michigan
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Lakewood	Colorado
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Upland	California
United States	GSK Investigational Site	West Haverstraw	New York
United States	GSK Investigational Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Relationship between biomarkers and changes in bone quality for one year.		1 Year

External Links

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