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Post Menopausal OsteoporosisPhase 4NCT02598934

A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Postmenopausal Osteoporosis

A Phase 4 study testing Ibandronate in people with Post Menopausal Osteoporosis, run by Hoffmann-La Roche at 53 sites in 2 countries.

Completed

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

Official record
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Trial summary

This study will evaluate whether an early positive response to once-monthly oral ibandronate in treatment-naive participants with postmenopausal osteoporosis is predictive of efficacy later in treatment. The anticipated time on study treatment is 6 months, and the target sample size is 360 individuals. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Post Menopausal Osteoporosis
What is being tested?
Ibandronate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
308 participants
Where
53 sitesin 2 countries
Study dates
Aug 2004to May 2006
Phase
Phase 4
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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Women newly diagnosed with postmenopausal osteoporosis
  • Naive to prior bisphosphonate therapy

Who cannot join

  • Inability to stand or sit upright for at least 60 minutes
  • Inability to swallow a tablet whole
  • Hypersensitivity to any component of ibandronate
  • Hormone (estrogen) replacement therapy within last 3 months, or will start on therapy within next 6 months
  • Other osteoporosis drug within last 3 months
  • Malignant disease diagnosed within previous 10 years, except resected basal cell cancer

Trial locations and contacts

53 sites in 2 countries.

53 sites in 2 countries

United States50 sites

  • Study site

    Amarillo, Texas, 79106

  • Study site

    Anaheim, California, 92801

  • Study site

    Atlanta, Georgia, 30309

  • Study site

    Baltimore, Maryland, 21209

  • Study site

    Beverly Hills, California, 90211

  • Study site

    Bloomfield, New Jersey, 07003

  • Study site

    Carmichael, California, 95608

  • Study site

    Chandler, Arizona, 85225

  • Study site

    DeLand, Florida, 32720

  • Study site

    Doylestown, Pennsylvania, 18901

  • Study site

    Fort Worth, Texas, 76101

  • Study site

    Hagerstown, Maryland, 21740

  • Study site

    Hot Springs, Arkansas, 71913

  • Study site

    Indianapolis, Indiana, 46202

  • Study site

    Jefferson City, Missouri, 65109

  • Study site

    Langhorne, Pennsylvania, 19047

  • Study site

    Madison, Wisconsin, 53705

  • Study site

    Medford, Oregon, 97504

  • Study site

    Miami, Florida, 33176

  • Study site

    Miami, Florida, 33186

  • Study site

    Montgomery, Alabama, 36111

  • Study site

    Morehead City, North Carolina, 28557

  • Study site

    Morganton, North Carolina, 28655

  • Study site

    Morristown, Tennessee, 37813

  • Study site

    Morton Grove, Illinois, 60053

  • Study site

    Mt. Pleasant, South Carolina, 29464

  • Study site

    Murfreesboro, Tennessee, 37130

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    New York, New York, 10016

  • Study site

    Oklahoma City, Oklahoma, 73112

  • Study site

    Olive Branch, Mississippi, 38654

  • Study site

    Omaha, Nebraska, 68131

  • Study site

    Palm Habor, Florida, 34684

  • Study site

    Palm Springs, Florida, 33461

  • Study site

    Peoria, Arizona, 85381

  • Study site

    Philadelphia, Pennsylvania, 19131

  • Study site

    Pine Bluff, Arkansas, 71603

  • Study site

    Raleigh, North Carolina, 27612

  • Study site

    Reistertown, Maryland, 21136

  • Study site

    Richmond, Virginia, 23226

  • Study site

    Rome, Georgia, 30165

  • Study site

    San Antonio, Texas, 78229

  • Study site

    Spartanburg, South Carolina, 29307

  • Study site

    St Louis, Missouri, 63108

  • Study site

    Tacoma, Washington, 98405

  • Study site

    Texarkana, Texas, 75503

  • Study site

    The Bronx, New York, 10461

  • Study site

    Waterloo, Iowa, 50702

  • Study site

    West Palm Beach, Florida, 33409

  • Study site

    Wilmington, Delaware, 19805

Other trials in United States

Puerto Rico3 sites

  • Study site

    Ponce, 00717-1318

  • Study site

    San Juan, 00927

  • Study site

    San Juan, 00935

Other trials in Puerto Rico

About this study

Official title: A Prospective Open-Label, Multicenter Study to Evaluate the Change in Bone Turnover Markers After Once Monthly Oral Ibandronate Therapy in Treatment Naive Postmenopausal Osteoporosis Patients

This study will evaluate whether an early positive response to once-monthly oral ibandronate in treatment-naive participants with postmenopausal osteoporosis is predictive of efficacy later in treatment. The anticipated time on study treatment is 6 months, and the target sample size is 360 individuals.

Being tested
Ibandronate
Medical subject headings
Osteoporosis, Postmenopausal

What participants receive

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

  • IbandronateDrug

    Also called Bonviva/Boniva

    Participants will receive oral ibandronate, 150 mg once weekly, for approximately 6 months.

Study groups in NCT02598934
Study groupRoleWhat they receive
Ibandronate Group 1ExperimentalParticipants will receive a 6-month regimen with oral ibandronate, 150 mg once monthly. Group 1 will receive a physician consultation after 4 months of treatment to review bone turnover test results.
Receives: Drug: Ibandronate
Ibandronate Group 2ExperimentalParticipants will receive a 6-month regimen with oral ibandronate, 150 mg once monthly. Group 2 will not receive a physician consultation.
Receives: Drug: Ibandronate

What is being measured

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

  1. Percent Change From Baseline to Month 6 in Serum C-terminal Telopeptide of Type 1 Collagen (CTX)

    Serum CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Percent change from Baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).

    Measured: Baseline, Month 6

Secondary outcomes (5)

  1. Percent Change From Baseline to Month 6 in Urine N-terminal Telopeptide of Type 1 Collagen (NTX)

    Urine NTX is a measure of bone resorption and is measured as millimoles bone collagen equivalents per millimoles creatinine. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).

    Measured: Baseline, Month 6

  2. Percent Change From Baseline to Month 6 in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)

    Serum P1NP is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus Baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).

    Measured: Baseline, Month 6

  3. Percent Change From Baseline to Month 6 in Serum Osteocalcin

    Serum osteocalcin is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).

    Measured: Baseline, Month 6

  4. Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (BSAP)

    Serum BSAP is a measure of bone resorption and is measured as ng/mL. Percent change from baseline to Month 6 was calculated using Month 6 value minus baseline value divided by baseline value, and then multiplied by 100. Data for this outcome measure was reported for all participants combined (Consult group plus Non-consult group).

    Measured: Baseline, Month 6

  5. Percentage of Participants Who Were "Very Confident" or "Confident" to Items on the Boniva Confidence Scale (BCS) at Month 6

    The BCS is designed to measure the participant's confidence level that Boniva (ibandronate) therapy is effective in treating osteoporosis and reducing the risk of fracture. Response options ranged on a 5-point scale from 'Not At All Confident' to 'Very Confident.' A Boniva confidence responder was defined as a participant who reported a response of 'confident' or 'very confident' on the 2 items in BCS. (1) ibandronate was effective in treating osteoporosis and (2) ibandronate reduces the risk of breaking a bone.

    Measured: Month 6

Timeline

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

  1. First posted6 Nov 2015 (estimated)
  2. Study startAug 2004
  3. Primary completionMay 2006
  4. Study completionMay 2006

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 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
308 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02598934
Sponsor's protocol ID
ML18057
Status last verified
Feb 2016
First submitted
4 Nov 2015
Last updated
9 Mar 2016

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ibandronate in people with Post Menopausal Osteoporosis, run by Hoffmann-La Roche at 53 sites in 2 countries.

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 2 inclusion and 6 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 9 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Puerto Rico. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 9 Mar 2016). 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?

Percent Change From Baseline to Month 6 in Serum C-terminal Telopeptide of Type 1 Collagen (CTX) (time frame: Baseline, Month 6). 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 NCT02598934.

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 9 Mar 2016.

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