The Effect Of Oral Ibandronate In Male Osteoporosis (STRONG)

November 17, 2009 updated by: Hoffmann-La Roche

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion criteria:

  • Ambulatory men at least 30 years old at screening, who are diagnosed with primary, idiopathic or hypogonadal osteoporosis according to the following criteria: Femoral neck (FN) BMD T-score < -2.0 and LS BMD T-score < -1.0 OR LS BMD T-score < -2.0 and FN BMD T-score < -1.0 and BMD T-score > 4.0 at any site
  • Subjects who, in the opinion of the investigator, are willing and able to comply with the protocol requirements
  • Subjects who have signed an informed consent

Exclusion criteria:

  • Significant medical conditions or laboratory abnormalities, which in the opinion of the investigator may preclude the patient's ability to complete the study
  • Malignant disease diagnosed within the previous 5 years (except resected basal cell cancer)
  • Disease/disorder known to influence bone metabolism or cause of secondary osteoporosis e.g., chronic gastrointestinal or liver disease, renal disease, chronic alcoholism, malabsorption syndrome
  • Hypersensitivity to any component of ibandronate
  • Inability to stand or sit in an upright position for at least 60 minutes
  • Inability to swallow a tablet without breaking it
  • Vitamin D deficiency (serum 25-OH vitamin D <20ng/mL (equivalent to 50nmol/L) at screening
  • Any prevalent osteoporotic vertebral fracture identified by total spine x-ray (Total spine x-ray consists of lateral and PA films of the thoracic & lumbar spine)
  • Subjects who are receiving testosterone supplementation for < 2 years (if applicable) (Patients who are identified with clinical signs of hypogonadism at screening and are started on testosterone supplementation will be excluded from participation.)
  • Contraindications to calcium or vitamin D therapy
  • Administration of any investigational drug within 30 days preceding the first dose of the study drug
  • Previous treatment with an oral bisphosphonate within the last six months, OR more than one month of cumulative treatment within the last year, OR more than three months of cumulative treatment within the last two years AND/OR treatment with intravenous bisphosphonate within one year.
  • Treatment with PTH or similar anabolic agent for osteoporosis within the last two years

  • Treatment with other drugs affecting bone metabolism within the last six months prior to Screening including:

    • Chronic systemic glucocorticoid treatment except for topical treatment at a frequency of up to twice per week
    • Calcineurin inhibitors [e.g., cyclosporine, tacrolimus] or methotrexate
    • Testosterone therapy (unless stabilized on medications > 2 years)
    • Calcitonin
    • Fluoride (dose greater than 10mg/day) or strontium for osteoporosis within the last 12 months, or past treatment for more than a total of 2 years
    • Selective estrogen receptor modulators (SERMS) such as raloxifene, toremifene, tamoxifen, arzoxifene and lasofoxifene
    • Anabolic steroids and other androgens, such as dehydroepiandrosterone (DHEA) or its sulphated form (DHEAs)
    • Active vitamin D analogs/metabolites such as1,25-dihydroxy vitamin D (calcitriol) or 1-alpha-hydroxy vitamin D3 (1 - alpha hydroxycholecalciferol)
    • Gonadotropin releasing antagonists (lupron)
  • ALT > twice upper limit of normal range of central laboratory
  • Hypercalcemia or uncorrected hypocalcemia: Serum total Ca 2+ > 10.5mg/dl or < 8.0 mg/dL (equivalent to 2.6 and 2.0 mmol/L)
  • GFR < 30 ml/min as determined by estimated creatinine clearance (CLcr) calculated by the Cockcroft-Gault equation:

CLcr = (140-age) * ABW X 0.85 72*Scr where : CLcr - estimated creatinine clearance Age - in years ABW - actual body weight at screening (kg) Scr - serum creatinine at screening (mg/dL)

  • History of major upper GI disease defined by:

    • Significant upper GI bleeding within the last year requiring hospitalization or transfusion
    • Recurrent peptic ulcer disease documented by radiographic or endoscopic means
    • Dyspepsia or gastroesophageal reflux that is uncontrolled by medication
    • Abnormalities of the esophagus that delay esophageal emptying, such as stricture, achalasia, or dysmotility
    • Active gastric/duodenal ulcers
    • Dyspepsia controlled by daily medication OR prior history of non-recurrent peptic ulcer disease are not considered exclusionary
  • WBC < 2500/µL
  • Serum albumin < 3.0g/dL
  • History of hyperthyroidism, hyperparathyroidism or osteomalacia within one year of study entry
  • Fewer than three (3) vertebrae in the range L1-L4 evaluable by DXA. Conditions which interfere with the BMD measurement include prevalent fracture, sequelae of orthopedic procedures (e.g., spinal fusion, metal implants, etc.), severe scoliosis and severe degenerative changes (e.g., osteophytes, sclerosis)
  • Bilateral hip replacement
  • Any restrictions, defined by site requirements for hrMRI procedure (for subset of hrMRI subjects)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: placebo
Placebo orally (tablet) at a dose of 150 mg once per month
Experimental: Ibandronate
Drug: Ibandronate
Ibandronate orally (tablet) at a dose of 150 mg once per month

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 12
Time Frame: 12 months
BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 6
Time Frame: 6 months
BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.
6 months
Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 12
Time Frame: 12 months
BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.
12 months
Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 6
Time Frame: 6 months
BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.
6 months
Responder Rate of Subjects Who Remained the Same or Had Any Improvement in BMD (>= Baseline) at 6 Months and 12 Months
Time Frame: 12 months
Responders are defined as participants who have BMD values >= their baseline values at Months 6 and 12, and not any pre-defined percentage increase in BMD values of clinical significance.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Collaborators

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

November 9, 2006

First Submitted That Met QC Criteria

November 9, 2006

First Posted (Estimate)

November 10, 2006

Study Record Updates

Last Update Posted (Estimate)

December 21, 2009

Last Update Submitted That Met QC Criteria

November 17, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BON105960

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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