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The Effect Of Oral Ibandronate In Male Osteoporosis (STRONG)

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ClinicalTrials.gov Identifier: NCT00397839
Recruitment Status : Completed
First Posted : November 10, 2006
Results First Posted : December 21, 2009
Last Update Posted : December 21, 2009
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Hoffmann-La Roche

November 9, 2006
November 10, 2006
November 17, 2009
December 21, 2009
December 21, 2009
January 2007
October 2008   (Final data collection date for primary outcome measure)
Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 12 [ Time Frame: 12 months ]
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
Complete list of historical versions of study NCT00397839 on ClinicalTrials.gov Archive Site
  • Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 6 [ Time Frame: 6 months ]
  • Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 12 [ Time Frame: 12 months ]
  • Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 6 [ Time Frame: 6 months ]
  • Responder Rate of Subjects Who Remained the Same or Had Any Improvement in BMD (>= Baseline) at 6 Months and 12 Months [ Time Frame: 12 months ]
To assess the safety and tolerability of oral ibandronate 150 mg once monthly in men with osteoporosis after one year
Not Provided
Not Provided
 
The Effect Of Oral Ibandronate In Male Osteoporosis
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Male Osteoporosis
  • Drug: Ibandronate
    Ibandronate orally (tablet) at a dose of 150 mg once per month
  • Drug: placebo
    Placebo orally (tablet) at a dose of 150 mg once per month
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
  • Experimental: Ibandronate
    Intervention: Drug: Ibandronate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
135
168
October 2008
October 2008   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Male
30 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00397839
BON105960
Not Provided
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Disclosures Group, Hoffmann-La Roche
Hoffmann-La Roche
GlaxoSmithKline
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
Hoffmann-La Roche
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP