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The Effect Of Oral Ibandronate In Male Osteoporosis

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Male Osteoporosis

Intervention: Ibandronate (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 12

Secondary outcome:

Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 6

Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 12

Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 6

Responder Rate of Subjects Who Remained the Same or Had Any Improvement in BMD (>= Baseline) at 6 Months and 12 Months

Eligibility

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Male.

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/┬ÁL

- 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)

Locations and Contacts

GSK Investigational Site, Birmingham, Alabama 35294-3708, United States

GSK Investigational Site, Tucson, Arizona 85704, United States

GSK Investigational Site, Beverly Hills, California 90211, United States

GSK Investigational Site, Greenbrae, California 94904, United States

GSK Investigational Site, Oakland, California 94609, United States

GSK Investigational Site, Palm Desert, California 92260, United States

GSK Investigational Site, Walnut Creek, California 94598, United States

GSK Investigational Site, Longmont, Colorado 80501, United States

GSK Investigational Site, Clearwater, Florida 33761, United States

GSK Investigational Site, Miami, Florida 33136, United States

GSK Investigational Site, Miami, Florida 33156, United States

GSK Investigational Site, Palm Harbor, Florida 34684, United States

GSK Investigational Site, West Palm Beach, Florida 33409, United States

GSK Investigational Site, Atlanta, Georgia 30342, United States

GSK Investigational Site, Decatur, Georgia 30033, United States

GSK Investigational Site, Gainsville, Georgia 30501, United States

GSK Investigational Site, Champaign, Illinois 61822, United States

GSK Investigational Site, Chicago, Illinois 60611, United States

GSK Investigational Site, Peoria, Illinois 61615, United States

GSK Investigational Site, Indianapolis, Indiana 46250, United States

GSK Investigational Site, Kansas City, Kansas 66160-7820, United States

GSK Investigational Site, Louisville, Kentucky 40202, United States

GSK Investigational Site, South Portland, Maine 04106, United States

GSK Investigational Site, Bathesda, Maryland 20817, United States

GSK Investigational Site, Wheaton, Maryland 20902, United States

GSK Investigational Site, Woodbury, Minnesota 55125, United States

GSK Investigational Site, Springfield, Missouri 65807, United States

GSK Investigational Site, Albuquerque, New Mexico 87106, United States

GSK Investigational Site, Asheville, North Carolina 28801, United States

GSK Investigational Site, Tulsa, Oklahoma 74104, United States

GSK Investigational Site, Portland, Oregon 97201, United States

GSK Investigational Site, Duncansville, Pennsylvania 16635, United States

GSK Investigational Site, Providence, Rhode Island 02908, United States

GSK Investigational Site, Charleston, South Carolina 29407, United States

GSK Investigational Site, Dallas, Texas 75216, United States

GSK Investigational Site, Richmond, Virginia 23249, United States

GSK Investigational Site, Salem, Virginia 24153, United States

GSK Investigational Site, Seattle, Washington 98108, United States

GSK Investigational Site, Seattle, Washington 98144, United States

GSK Investigational Site, Beckley, West Virginia 25801, United States

GSK Investigational Site, Madison, Wisconsin 53705, United States

Additional Information

Starting date: January 2007
Last updated: November 17, 2009

Page last updated: August 23, 2015

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