The Effect Of Oral Ibandronate In Male Osteoporosis

Male Osteoporosis Clinical Trial

— STRONG  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00397839
• Other study ID #: BON105960
• Status: Completed
• Phase: Phase 3
• First received: November 9, 2006
• Last updated: November 17, 2009
• Start date: January 2007
• Est. completion date: October 2008

Study information

• Verified date: November 2009
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Male Osteoporosis
• Osteoporosis

Intervention

Drug:
• Ibandronate
Ibandronate orally (tablet) at a dose of 150 mg once per month
• placebo
Placebo orally (tablet) at a dose of 150 mg once per month

Locations

Country	Name	City	State
United States	GSK Investigational Site	Albuquerque	New Mexico
United States	GSK Investigational Site	Asheville	North Carolina
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Bathesda	Maryland
United States	GSK Investigational Site	Beckley	West Virginia
United States	GSK Investigational Site	Beverly Hills	California
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Champaign	Illinois
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Clearwater	Florida
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Decatur	Georgia
United States	GSK Investigational Site	Duncansville	Pennsylvania
United States	GSK Investigational Site	Gainsville	Georgia
United States	GSK Investigational Site	Greenbrae	California
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Kansas City	Kansas
United States	GSK Investigational Site	Longmont	Colorado
United States	GSK Investigational Site	Louisville	Kentucky
United States	GSK Investigational Site	Madison	Wisconsin
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Oakland	California
United States	GSK Investigational Site	Palm Desert	California
United States	GSK Investigational Site	Palm Harbor	Florida
United States	GSK Investigational Site	Peoria	Illinois
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Providence	Rhode Island
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Salem	Virginia
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	Seattle	Washington
United States	GSK Investigational Site	South Portland	Maine
United States	GSK Investigational Site	Springfield	Missouri
United States	GSK Investigational Site	Tucson	Arizona
United States	GSK Investigational Site	Tulsa	Oklahoma
United States	GSK Investigational Site	Walnut Creek	California
United States	GSK Investigational Site	West Palm Beach	Florida
United States	GSK Investigational Site	Wheaton	Maryland
United States	GSK Investigational Site	Woodbury	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 12		12 months	No
Secondary	Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 6		6 months	No
Secondary	Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 12		12 months	No
Secondary	Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 6		6 months	No
Secondary	Responder Rate of Subjects Who Remained the Same or Had Any Improvement in BMD (>= Baseline) at 6 Months and 12 Months		12 months	No