The Effect Of Oral Ibandronate In Male Osteoporosis

Condition(s) targeted: Osteoporosis

Intervention: Ibandronate (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: GlaxoSmithKline

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

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.

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: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: To demonstrate the efficacy of once-monthly 150 mg ibandronate in the treatment of men with primary, idiopathic or hypogonadal osteoporosis on lumbar spine BMD compared to placebo at one year

Secondary outcome:

To assess the safety and tolerability of oral ibandronate 150 mg once monthly in men with osteoporosis after one year

LS BMD mean % change from baseline at 6 months

Proximal femur sites (total hip, trochanter, femoral neck) BMD mean % change from baseline at 6 and 12 months

The mean % change from baseline of serum CTX (biochemical marker of bone resorption) and BSAP (biochemical marker of bone formation) at 3, 6, and 12 months

Responder rate of subjects who remained the same or had any improvement in BMD (> baseline) at 12 months

Hip structural analysis of DXA at 12 months Exploratory Endpoint:

Change from baseline in trabecular number, spacing and bone volume fraction as measured by high resolution magnetic resonance imaging (hrMRI) of the radius and tibia in a subset of 15 subjects at 12 months

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/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)

GSK Clinical Trials Call Center, Birmingham, Alabama 35294, United States; Recruiting
Kenneth Saag, Phone: 877-379-3718

GSK Clinical Trials Call Center, Tuscon, Arizona 85704, United States; Recruiting
Michael Maricic, Phone: 877-379-3718

GSK Clinical Trials Call Center, Palm Desert, California 92260, United States; Recruiting
Maria Greenwald, Phone: 877-379-3718

GSK Clinical Trials Call Center, Beverly Hills, California 90211, United States; Completed

GSK Clinical Trials Call Center, Oakland, California 94609, United States; Recruiting
Elliott Schwartz, Phone: 877-379-3718

GSK Clinical Trials Call Center, Greenbrae, California 94904, United States; Recruiting
Richard Bernstein, Phone: 877-379-3718

GSK Clinical Trials Call Center, Walnut Creek, California 94598, United States; Recruiting
Richard Weinstein, Phone: 877-379-3718

GSK Clinical Trials Call Center, Longmont, Colorado 80501, United States; Recruiting
David Podlecki, Phone: 877-379-3718

GSK Clinical Trials Call Center, Miami, Florida 33136, United States; Recruiting
Silvina Levis-Dusseau, Phone: 877-379-3718

GSK Clinical Trials Call Center, Miami, Florida 33156, United States; Completed

GSK Clinical Trials Call Center, West Palm Beach, Florida 33409, United States; Recruiting
Ronald Ackerman, Phone: 877-379-3718

GSK Clinical Trials Call Center, Clearwater, Florida 33761, United States; Completed

GSK Clinical Trials Call Center, Palm Harbor, Florida 34684, United States; Recruiting
Anthony Sebba, Phone: 877-379-3718

GSK Clinical Trials Call Center, Roswell, Georgia 30075, United States; Completed

GSK Clinical Trials Call Center, Gainesville, Georgia 30501, United States; Recruiting
Chris Recknor, Phone: 877-379-3718

GSK Clinical Trials Call Center, Decatur, Georgia 30033, United States; Completed

GSK Clinical Trials Call Center, Peoria, Illinois 61615, United States; Recruiting
Stephen Hippler, Phone: 877-379-3718

GSK Clinical Trials Call Center, Champaign, Illinois 61820, United States; Completed

GSK Clinical Trials Call Center, Chicago, Illinois 60611, United States; Completed

GSK Clinical Trials Call Center, Indianapolis, Indiana 46250, United States; Recruiting
Rashid Khairi, Phone: 877-379-3718

GSK Clinical Trials Call Center, Kansas City, Kansas 66160, United States; Recruiting
Rajib Bhattacharya, Phone: 877-379-3718

GSK Clinical Trials Call Center, Louisville, Kentucky 40202, United States; Completed

GSK Clinical Trials Call Center, South Portland, Maine 04106, United States; Completed

GSK Clinical Trials Call Center, Bethesda, Maryland 20817, United States; Recruiting
Michael Bolognese, Phone: 877-379-3718

GSK Clinical Trials Call Center, Wheaton, Maryland 20902, United States; Recruiting
Robert Rosenberg, Phone: 877-379-3718

GSK Clinical Trials Call Center, Woodbury, Minnesota 55125, United States; Completed

GSK Clinical Trials Call Center, Springfield, Missouri 65807, United States; Recruiting
Gregory Ledger, Phone: 877-379-3718

GSK Clinical Trials Call Center, Albuquerque, New Mexico 87106, United States; Recruiting
Michael Lewiecki, Phone: 877-379-3718

GSK Clinical Trials Call Center, Asheville, North Carolina 28801, United States; Recruiting
Jill Vargo, Phone: 877-379-3718

GSK Clinical Trials Call Center, Cleveland, Ohio 44195, United States; Terminated

GSK Clinical Trials Call Center, Tulsa, Oklahoma 74104, United States; Completed

GSK Clinical Trials Call Center, Portland, Oregon 97239, United States; Recruiting
Chaim Vanek, Phone: 877-379-3718

GSK Clinical Trials Call Center, Duncansville, Pennsylvania 16635, United States; Recruiting
Alan Kivitz, Phone: 877-379-3718

GSK Clinical Trials Call Center, Providence, Rhode Island 02908, United States; Recruiting
Joseph Tucci, Phone: 877-379-3718

GSK Clinical Trials Call Center, Charleston, South Carolina 29407, United States; Completed

GSK Clinical Trials Call Center, Dallas, Texas 75216, United States; Recruiting
Ugis Gruntmanis, Phone: 877-379-3718

GSK Clinical Trials Call Center, Salem, Virginia 24153, United States; Recruiting
Ali Iranmanesh, Phone: 877-379-3718

GSK Clinical Trials Call Center, Richmond, Virginia 23249, United States; Recruiting
Robert Adler, Phone: 877-379-3718

GSK Clinical Trials Call Center, Seattle, Washington 98144, United States; Recruiting
Andrew Shields, Phone: 877-379-3718

GSK Clinical Trials Call Center, Seattle, Washington 98108, United States; Completed

GSK Clinical Trials Call Center, Beckley, West Virginia 25801, United States; Recruiting
Wassim Saikali, Phone: 877-379-3718

GSK Clinical Trials Call Center, Madison, Wisconsin 53705, United States; Recruiting
Neil Binkley, Phone: 877-379-3718

Starting date: January 2007
Ending date: October 2008
Last updated: May 29, 2008