The Effect Of Oral Ibandronate In Male Osteoporosis

NCT00397839 | Completed Phase 3 Results

• 1 other identifier: BON105960
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 41

Brief 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.

Conditions

Male Osteoporosis

Keywords

male osteoporosis; osteoporosis; bisphonates; bone

Outcome Measures

Primary Outcomes (1)

• Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 12

  BMD will be assessed using an analysis of covariance model (ANCOVA) with datea obtained from dual-Energy X-ray absorptiometry scans.

  12 months

Secondary Outcomes (4)

• Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 6

  6 months

• Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 12

  12 months

• Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) From Baseline to Month 6

  6 months

• Responder Rate of Subjects Who Remained the Same or Had Any Improvement in BMD (>= Baseline) at 6 Months and 12 Months

  12 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: placebo

Ibandronate

EXPERIMENTAL

Drug: Ibandronate

Interventions

Ibandronate DRUG

Ibandronate orally (tablet) at a dose of 150 mg once per month

Ibandronate

placebo DRUG

Placebo orally (tablet) at a dose of 150 mg once per month

Placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• GlaxoSmithKline: collaborator

Study Sites (41)

GSK Investigational Site

Birmingham, Alabama, 35294-3708, United States

Location

GSK Investigational Site

Tucson, Arizona, 85704, United States

Location

GSK Investigational Site

Beverly Hills, California, 90211, United States

Location

GSK Investigational Site

Greenbrae, California, 94904, United States

Location

GSK Investigational Site

Oakland, California, 94609, United States

Location

GSK Investigational Site

Palm Desert, California, 92260, United States

Location

GSK Investigational Site

Walnut Creek, California, 94598, United States

Location

GSK Investigational Site

Longmont, Colorado, 80501, United States

Location

GSK Investigational Site

Clearwater, Florida, 33761, United States

Location

GSK Investigational Site

Miami, Florida, 33136, United States

Location

GSK Investigational Site

Miami, Florida, 33156, United States

Location

GSK Investigational Site

Palm Harbor, Florida, 34684, United States

Location

GSK Investigational Site

West Palm Beach, Florida, 33409, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30342, United States

Location

GSK Investigational Site

Decatur, Georgia, 30033, United States

Location

GSK Investigational Site

Gainsville, Georgia, 30501, United States

Location

GSK Investigational Site

Champaign, Illinois, 61822, United States

Location

GSK Investigational Site

Chicago, Illinois, 60611, United States

Location

GSK Investigational Site

Peoria, Illinois, 61615, United States

Location

GSK Investigational Site

Indianapolis, Indiana, 46250, United States

Location

GSK Investigational Site

Kansas City, Kansas, 66160-7820, United States

Location

GSK Investigational Site

Louisville, Kentucky, 40202, United States

Location

GSK Investigational Site

South Portland, Maine, 04106, United States

Location

GSK Investigational Site

Bathesda, Maryland, 20817, United States

Location

GSK Investigational Site

Wheaton, Maryland, 20902, United States

Location

GSK Investigational Site

Woodbury, Minnesota, 55125, United States

Location

GSK Investigational Site

Springfield, Missouri, 65807, United States

Location

GSK Investigational Site

Albuquerque, New Mexico, 87106, United States

Location

GSK Investigational Site

Asheville, North Carolina, 28801, United States

Location

GSK Investigational Site

Tulsa, Oklahoma, 74104, United States

Location

GSK Investigational Site

Portland, Oregon, 97201, United States

Location

GSK Investigational Site

Duncansville, Pennsylvania, 16635, United States

Location

GSK Investigational Site

Providence, Rhode Island, 02908, United States

Location

GSK Investigational Site

Charleston, South Carolina, 29407, United States

Location

GSK Investigational Site

Dallas, Texas, 75216, United States

Location

GSK Investigational Site

Richmond, Virginia, 23249, United States

Location

GSK Investigational Site

Salem, Virginia, 24153, United States

Location

GSK Investigational Site

Seattle, Washington, 98108, United States

Location

GSK Investigational Site

Seattle, Washington, 98144, United States

Location

GSK Investigational Site

Beckley, West Virginia, 25801, United States

Location

GSK Investigational Site

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Ibandronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

800-821-8590

Study Officials

• GSK Clinical Trials, MD

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 9, 2006
• First Posted: November 10, 2006
• Study Start: January 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: December 21, 2009
• Results First Posted: December 21, 2009

Record last verified: 2009-11

Locations

US (41)