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Completed Phase 3 Interventional Results available

The Effect Of Oral Ibandronate In Male Osteoporosis

ClinicalTrials.gov ID: NCT00397839

Public ClinicalTrials.gov record NCT00397839. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 24, 2026, 5:01 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Parallel, Placebo-controlled, Randomized (2:1) Double-blind Study of One Year Duration to Assess the Effect of Oral Ibandronate 150 mg Given Once-monthly Versus Placebo on LS BMD in Men With Osteoporosis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Male osteoporosis is a common and important clinical problem, associated with significant morbidity, mortality and societal expense. Approximately 10% of men =65 years of age are osteoporotic. The proposed study will evaluate efficacy and safety of oral ibandronate given 150 mg once-monthly for 12 months versus placebo in men with primary osteoporosis. Less frequent, once monthly, dosing is expected to improve patient's treatment adherence compared to a weekly dosing regimen.

Study identification

NCT ID
NCT00397839
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
135 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
30 Years and older
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2006
Primary completion
Sep 30, 2008
Completion
Sep 30, 2008
Last update posted
Dec 20, 2009

2007 – 2008

United States locations

U.S. sites
41
U.S. states
26
U.S. cities
39
Facility City State ZIP Site status
GSK Investigational Site Birmingham Alabama 35294-3708 —
GSK Investigational Site Tucson Arizona 85704 —
GSK Investigational Site Beverly Hills California 90211 —
GSK Investigational Site Greenbrae California 94904 —
GSK Investigational Site Oakland California 94609 —
GSK Investigational Site Palm Desert California 92260 —
GSK Investigational Site Walnut Creek California 94598 —
GSK Investigational Site Longmont Colorado 80501 —
GSK Investigational Site Clearwater Florida 33761 —
GSK Investigational Site Miami Florida 33136 —
GSK Investigational Site Miami Florida 33156 —
GSK Investigational Site Palm Harbor Florida 34684 —
GSK Investigational Site West Palm Beach Florida 33409 —
GSK Investigational Site Atlanta Georgia 30342 —
GSK Investigational Site Decatur Georgia 30033 —
GSK Investigational Site Gainsville Georgia 30501 —
GSK Investigational Site Champaign Illinois 61822 —
GSK Investigational Site Chicago Illinois 60611 —
GSK Investigational Site Peoria Illinois 61615 —
GSK Investigational Site Indianapolis Indiana 46250 —
GSK Investigational Site Kansas City Kansas 66160-7820 —
GSK Investigational Site Louisville Kentucky 40202 —
GSK Investigational Site South Portland Maine 04106 —
GSK Investigational Site Bathesda Maryland 20817 —
GSK Investigational Site Wheaton Maryland 20902 —
GSK Investigational Site Woodbury Minnesota 55125 —
GSK Investigational Site Springfield Missouri 65807 —
GSK Investigational Site Albuquerque New Mexico 87106 —
GSK Investigational Site Asheville North Carolina 28801 —
GSK Investigational Site Tulsa Oklahoma 74104 —
GSK Investigational Site Portland Oregon 97201 —
GSK Investigational Site Duncansville Pennsylvania 16635 —
GSK Investigational Site Providence Rhode Island 02908 —
GSK Investigational Site Charleston South Carolina 29407 —
GSK Investigational Site Dallas Texas 75216 —
GSK Investigational Site Richmond Virginia 23249 —
GSK Investigational Site Salem Virginia 24153 —
GSK Investigational Site Seattle Washington 98108 —
GSK Investigational Site Seattle Washington 98144 —
GSK Investigational Site Beckley West Virginia 25801 —
GSK Investigational Site Madison Wisconsin 53705 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00397839, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 20, 2009 · Synced Sep 24, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00397839 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →