The Effect Of Oral Ibandronate In Male Osteoporosis
Condition: Male Osteoporosis
MeSH terms: Osteoporosis
Intervention: Ibandronate; placebo
Intervention description: Ibandronate orally (tablet) at a dose of 150 mg once per month; Placebo orally (tablet) at a dose of 150 mg once per month
Intervention MeSH terms: Ibandronic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 135.0
Sex: Male
Minimum age: 30 Years
Healthy volunteers: No
Keywords: male osteoporosis; osteoporosis; bisphonates; bone

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.
    

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)