The Effect Of Oral Ibandronate In Male Osteoporosis

NCT ID: NCT00397839

Last Updated: 2009-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2008-10-31

Brief Summary

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.

Conditions

Male Osteoporosis

Keywords

male osteoporosis; osteoporosis; bisphonates; bone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Placebo orally (tablet) at a dose of 150 mg once per month

Ibandronate

Group Type: EXPERIMENTAL

Ibandronate

Intervention Type: DRUG

Ibandronate orally (tablet) at a dose of 150 mg once per month

Interventions

Ibandronate

Ibandronate orally (tablet) at a dose of 150 mg once per month

Intervention Type: DRUG

placebo

Placebo orally (tablet) at a dose of 150 mg once per month

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Hoffmann-La Roche

Principal Investigators

GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Tucson, Arizona, United States

GSK Investigational Site

Beverly Hills, California, United States

GSK Investigational Site

Greenbrae, California, United States

GSK Investigational Site

Oakland, California, United States

GSK Investigational Site

Palm Desert, California, United States

GSK Investigational Site

Walnut Creek, California, United States

GSK Investigational Site

Longmont, Colorado, United States

GSK Investigational Site

Clearwater, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Palm Harbor, Florida, United States

GSK Investigational Site

West Palm Beach, Florida, United States

GSK Investigational Site

Atlanta, Georgia, United States

GSK Investigational Site

Decatur, Georgia, United States

GSK Investigational Site

Gainsville, Georgia, United States

GSK Investigational Site

Champaign, Illinois, United States

GSK Investigational Site

Chicago, Illinois, United States

GSK Investigational Site

Peoria, Illinois, United States

GSK Investigational Site

Indianapolis, Indiana, United States

GSK Investigational Site

Kansas City, Kansas, United States

GSK Investigational Site

Louisville, Kentucky, United States

GSK Investigational Site

South Portland, Maine, United States

GSK Investigational Site

Bathesda, Maryland, United States

GSK Investigational Site

Wheaton, Maryland, United States

GSK Investigational Site

Woodbury, Minnesota, United States

GSK Investigational Site

Springfield, Missouri, United States

GSK Investigational Site

Albuquerque, New Mexico, United States

GSK Investigational Site

Asheville, North Carolina, United States

GSK Investigational Site

Tulsa, Oklahoma, United States

GSK Investigational Site

Portland, Oregon, United States

GSK Investigational Site

Duncansville, Pennsylvania, United States

GSK Investigational Site

Providence, Rhode Island, United States

GSK Investigational Site

Charleston, South Carolina, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

Richmond, Virginia, United States

GSK Investigational Site

Salem, Virginia, United States

GSK Investigational Site

Seattle, Washington, United States

GSK Investigational Site

Seattle, Washington, United States

GSK Investigational Site

Beckley, West Virginia, United States

GSK Investigational Site

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

BON105960

Identifier Type: -

Identifier Source: org_study_id