The Effect Of Oral Ibandronate In Male Osteoporosis

Completed · Phase 3 · Has a placebo group

Conditions studied: Male Osteoporosis

In brief

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.

Key facts

Study ID

NCT00397839

Run by

Hoffmann-La Roche

People needed

135

Starts

2007-01-01

Expected to finish

2008-10-01

Last updated by the study team

2009-12-21

Who can join

Age: 30 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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