Clinical trial NCT02948881: A Study To Assess The Quality Of Bone In Patients Taking Oral Ibandronate Versus Placebo
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoporosis
Keywords: Osteoporosis
bisphosphonates
bone
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2016-10-31
Enrollment: 100
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: 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.
timeFrame: 1 Year
Secondary outcomes:
measure: Relationship between biomarkers and changes in bone quality for one year.
timeFrame: 1 Year
Other outcomes:
Locations:
city: Upland
country: United States
facility: GSK Investigational Site
state: California
city: Boulder
country: United States
facility: GSK Investigational Site
state: Colorado
city: Lakewood
country: United States
facility: GSK Investigational Site
state: Colorado
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: Miami
country: United States
facility: GSK Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Decatur
country: United States
facility: GSK Investigational Site
state: Georgia
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
city: Bangor
country: United States
facility: GSK Investigational Site
state: Maine
city: Bathesda
country: United States
facility: GSK Investigational Site
state: Maryland
city: Flint
country: United States
facility: GSK Investigational Site
state: Michigan
city: Albuquerque
country: United States
facility: GSK Investigational Site
state: New Mexico
city: West Haverstraw
country: United States
facility: GSK Investigational Site
state: New York
city: Duncansville
country: United States
facility: GSK Investigational Site
state: Pennsylvania
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: