Clinical trial NCT00148915: A Study To Assess the Quality and Strength of Bone in Women Participants With Osteoporosis Taking Oral Ibandronate Versus Placebo
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoporosis
Keywords: Osteoporosis
bisphosphonates
bone
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 98
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 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.


Eligibility criteria: 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)

Primary outcomes:
measure: 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
timeFrame: Year 1
Secondary outcomes:
measure: Mean percent change in BMD of the proximal femur and lumbar spine according to vQCT at one year
timeFrame: Year 1
measure: Mean percent change of proximal femur and spine BMD according to Dual- Energy X-ray Absorptiometry (DXA) scans
timeFrame: Year 1
measure: Hip geometry assessed by cross-sectional dimensions of hip using vQCT
timeFrame: Year 1
measure: Finite element composition of hip and spine to estimate hip and spine strength
timeFrame: Year 1
measure: Hip geometry assessed by cross-sectional dimensions of hip using DXA
timeFrame: Year 1
measure: Trabecular bone dimensions by bone biopsies using histomorphometry and micro computed tomography to assess bone quality
timeFrame: Year 1
measure: Change from baseline for serum-C-terminal cross-linking telopeptide of Type I collagen (Serum-CTX)
timeFrame: Months 3, 6, 9, and 12
measure: Change from baseline for bone-specific alkaline phosphatase (Bone ALP)
timeFrame: Months 3, 6, 9, and 12
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: 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: Hoffmann-La Roche
name: HoffmannLaRoche Clinical Trials, MD
role: STUDY_DIRECTOR
References: