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Male OsteoporosisPhase 3STRONGNCT00397839

The Effect Of Oral Ibandronate In Male Osteoporosis

A Phase 3 study testing Ibandronate in people with Male Osteoporosis, run by Hoffmann-La Roche at 41 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 30 years and older, men only
Conditions the study is for
Male Osteoporosis
What is being tested?
Ibandronate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
135 participants
Where
41 sitesUnited States
Study dates
Jan 2007to Oct 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 40Show fewer
  • 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 72Scr 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)

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

United States41 sites

  • GSK Investigational Site

    Albuquerque, New Mexico, 87106

  • GSK Investigational Site

    Asheville, North Carolina, 28801

  • GSK Investigational Site

    Atlanta, Georgia, 30342

  • GSK Investigational Site

    Bathesda, Maryland, 20817

  • GSK Investigational Site

    Beckley, West Virginia, 25801

  • GSK Investigational Site

    Beverly Hills, California, 90211

  • GSK Investigational Site

    Birmingham, Alabama, 35294-3708

  • GSK Investigational Site

    Champaign, Illinois, 61822

  • GSK Investigational Site

    Charleston, South Carolina, 29407

  • GSK Investigational Site

    Chicago, Illinois, 60611

  • GSK Investigational Site

    Clearwater, Florida, 33761

  • GSK Investigational Site

    Dallas, Texas, 75216

  • GSK Investigational Site

    Decatur, Georgia, 30033

  • GSK Investigational Site

    Duncansville, Pennsylvania, 16635

  • GSK Investigational Site

    Gainsville, Georgia, 30501

  • GSK Investigational Site

    Greenbrae, California, 94904

  • GSK Investigational Site

    Indianapolis, Indiana, 46250

  • GSK Investigational Site

    Kansas City, Kansas, 66160-7820

  • GSK Investigational Site

    Longmont, Colorado, 80501

  • GSK Investigational Site

    Louisville, Kentucky, 40202

  • GSK Investigational Site

    Madison, Wisconsin, 53705

  • GSK Investigational Site

    Miami, Florida, 33136

  • GSK Investigational Site

    Miami, Florida, 33156

  • GSK Investigational Site

    Oakland, California, 94609

  • GSK Investigational Site

    Palm Desert, California, 92260

  • GSK Investigational Site

    Palm Harbor, Florida, 34684

  • GSK Investigational Site

    Peoria, Illinois, 61615

  • GSK Investigational Site

    Portland, Oregon, 97201

  • GSK Investigational Site

    Providence, Rhode Island, 02908

  • GSK Investigational Site

    Richmond, Virginia, 23249

  • GSK Investigational Site

    Salem, Virginia, 24153

  • GSK Investigational Site

    Seattle, Washington, 98108

  • GSK Investigational Site

    Seattle, Washington, 98144

  • GSK Investigational Site

    South Portland, Maine, 04106

  • GSK Investigational Site

    Springfield, Missouri, 65807

  • GSK Investigational Site

    Tucson, Arizona, 85704

  • GSK Investigational Site

    Tulsa, Oklahoma, 74104

  • GSK Investigational Site

    Walnut Creek, California, 94598

  • GSK Investigational Site

    West Palm Beach, Florida, 33409

  • GSK Investigational Site

    Wheaton, Maryland, 20902

  • GSK Investigational Site

    Woodbury, Minnesota, 55125

Other trials in United States

About this study

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

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.

Being tested
Ibandronate, placebo
Keywords
male osteoporosis, osteoporosis, bisphonates, bone
Medical subject headings
Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IbandronateDrug

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

  • placeboDrug

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

Study groups in NCT00397839
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: placebo
IbandronateExperimentalNot described
Receives: Drug: Ibandronate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (4)

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

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

    Measured: 6 months

  2. Mean Percent Change in BMD of Proximal Femur Sites (Total Hip, Trochanter, Femoral Neck) 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.

    Measured: 12 months

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

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

    Measured: 6 months

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

    Responders are defined as participants who have BMD values >= their baseline values at Months 6 and 12, and not any pre-defined percentage increase in BMD values of clinical significance.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2006 (estimated)
  2. Study startJan 2007
  3. Primary completionOct 2008
  4. Study completionOct 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00397839
Sponsor's protocol ID
BON105960
Acronym
STRONG
Status last verified
Nov 2009
First submitted
9 Nov 2006
Last updated
21 Dec 2009

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ibandronate in people with Male Osteoporosis, run by Hoffmann-La Roche at 41 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Percent Change in BMD of the Lumbar Spine From Baseline to Month 12 (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00397839.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2009.

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