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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00148915

Enrollment

Registered

2005-09-08

Start date

2005-08-31

Completion date

2007-08-31

Last updated

2016-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

Osteoporosis, bisphosphonates, bone

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.

Interventions

DRUGibandronate

DRUGPlacebo

matching placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

55 Years to 80 Years

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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
Mean percent change in BMD of the proximal femur and lumbar spine according to vQCT at one year	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
Hip geometry assessed by cross-sectional dimensions of hip using DXA	Year 1

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026