The Effect Of Oral Ibandronate In Male Osteoporosis (STRONG)

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00397839
First received: November 9, 2006
Last updated: November 17, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Male Osteoporosis
Drug: Ibandronate
Drug: placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 12 [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 6 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 12 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 6 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 135
Study Start Date: January 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: placebo
Placebo orally (tablet) at a dose of 150 mg once per month
Experimental: Ibandronate Drug: Ibandronate
Ibandronate orally (tablet) at a dose of 150 mg once per month

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00397839

  Show 41 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00397839     History of Changes
Other Study ID Numbers: BON105960
Study First Received: November 9, 2006
Results First Received: November 17, 2009
Last Updated: November 17, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Hoffmann-La Roche:
male osteoporosis
osteoporosis
bisphonates
bone

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Ibandronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014