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Postmenopausal OsteoporosisPhase 4NCT02598453

PRIOR Study - A Study of Ibandronate (Boniva) in Postmenopausal Women With Osteoporosis or Osteopenia

A Phase 4 study testing Ibandronate in people with Postmenopausal Osteoporosis, run by Hoffmann-La Roche at 60 sites in United States.

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

The purpose of this study is to evaluate treatment adherence to different regimens of ibandronate in postmenopausal women with osteoporosis or osteopenia who are intolerant to daily or weekly alendronate or risedronate therapy due to gastrointestinal (GI) side effects. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Postmenopausal Osteoporosis
What is being tested?
Ibandronate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
545 participants
Where
60 sitesUnited States
Study dates
Jan 2005to Sep 2006
Phase
Phase 4
Are there results?
None posted in the registry

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 with postmenopausal osteoporosis or osteopenia
  • Discontinuation of daily and /or weekly alendronate or risedronate therapy because of GI intolerance (eg, heartburn, acid reflux, stomach upset)

Who cannot join

  • Inability to stand or sit upright for 60 minutes
  • Inability to swallow a tablet whole - Hypersensitivity to any component of Boniva
  • Malignant disease diagnosed within previous 10 years (except resected basal cell cancer); contraindications for calcium or vitamin D therapy
  • Patients who do not fulfill a minimum 3 months wash-out therapy from any previous bisphosphonate therapy

Trial locations and contacts

60 sites in 1 country.

60 sites in 1 country

United States60 sites

  • Study site

    Albuquerque, New Mexico, 87106

  • Study site

    Augusta, Georgia, 30904

  • Study site

    Beverly Hills, Florida, 34464

  • Study site

    Billings, Montana, 59101

  • Study site

    Bismarck, North Dakota, 58501

  • Study site

    Bristol, Tennessee, 37620

  • Study site

    Broken Bow, Nebraska, 68822

  • Study site

    Canfield, Ohio, 44406

  • Study site

    Champaign, Illinois, 61820

  • Study site

    Charlotte, North Carolina, 28209

  • Study site

    Chaska, Minnesota, 55318

  • Study site

    Coeur d'Alene, Idaho, 83814

  • Study site

    Columbus, Ohio, 43213

  • Study site

    Dallas, Texas, 75231

  • Study site

    Denton, Texas, 76210

  • Study site

    Detroit, Michigan, 48202-2689

  • Study site

    Detroit, Michigan, 48236

  • Study site

    Durham, North Carolina, 27704

  • Study site

    Evansville, Indiana, 47714

  • Study site

    Fargo, North Dakota, 58104

  • Study site

    Fort Myers, Florida, 33901

  • Study site

    Gainesville, Florida, 32605

  • Study site

    Kansas City, Missouri, 64114

  • Study site

    Lake Havasu City, Arizona, 86403

  • Study site

    Las Vegas, Nevada, 89104

  • Study site

    Loris, South Carolina, 29569

  • Study site

    Madison, Wisconsin, 53792

  • Study site

    Mayfield, Ohio, 44143

  • Study site

    Miami, Florida, 33186

  • Study site

    Montgomery, Alabama, 36116

  • Study site

    Mt. Pleasant, South Carolina, 29464

  • Study site

    Natchitoches, Louisiana, 71457

  • Study site

    New York, New York, 10003

  • Study site

    Norfolk, Virginia, 23502

  • Study site

    Ocala, Florida, 34471

  • Study site

    Oklahoma City, Oklahoma, 73112

  • Study site

    Palm Harbor, Florida, 34684

  • Study site

    Paradise Valley, Arizona, 85253

  • Study site

    Pine Bluff, Arkansas, 71603

  • Study site

    Richmond, Virginia, 23294

  • Study site

    Richmond, Virginia, 23298

  • Study site

    Salisbury, North Carolina, 28144

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Antonio, Texas, 78238

  • Study site

    San Diego, California, 92103

  • Study site

    San Diego, California, 92108

  • Study site

    Santa Monica, California, 90404

  • Study site

    Scottsbluff, Nebraska, 69361

  • Study site

    Seguin, Texas, 78155

  • Study site

    Sioux Falls, South Dakota, 57105

  • Study site

    South Portland, Maine, 04106

  • Study site

    St Louis, Missouri, 63033

  • Study site

    Tacoma, California, 98405

  • Study site

    Temple, Texas, 76508

  • Study site

    Vista, California, 92083

  • Study site

    Watertown, South Dakota, 57201

  • Study site

    West Haverstraw, New York, 10993

  • Study site

    West Palm Beach, Florida, 33409

  • Study site

    Winston-Salem, North Carolina, 27103

  • Study site

    Wyomissing, Pennsylvania, 19610

Other trials in United States

About this study

Official title: An Open-Label, Multi-Center Study to Determine Level of Adherence to Monthly Oral or Every Three Month Intravenous Ibandronate Treatment in Post-Menopausal Women With Osteoporosis or Osteopenia, Who Are GI Intolerant of Daily or Weekly Alendronate or Risendronate

The purpose of this study is to evaluate treatment adherence to different regimens of ibandronate in postmenopausal women with osteoporosis or osteopenia who are intolerant to daily or weekly alendronate or risedronate therapy due to gastrointestinal (GI) side effects. The anticipated time on study treatment is 12 months, and the target sample size is 517 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

    Either 150 mg oral tablet once monthly or 3 mg IV injection once every 3 months

Study groups in NCT02598453
Study groupRoleWhat they receive
Ibandronate IVExperimentalParticipants will receive ibandronate 3 mg IV once every 3 months
Receives: Drug: Ibandronate
Ibandronate OralExperimentalParticipants will receive ibandronate 150 milligrams (mg) tablet once monthly
Receives: Drug: Ibandronate

What is being measured

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

  1. Percentage of participants who have greater than or equal to (>=) 75 percent (%) adherence using either monthly oral ibandronate or quarterly intravenous (IV) ibandronate

    Measured: 12 months

Secondary outcomes (3)

  1. Percentage of participants who have an adherence of >= 75% using ibandronate including both switch and non-switch participants

    Measured: 12 months

  2. Percentage of participants with GI events based on severity

    Measured: Up to 10 months

  3. Percentage of participants who experienced a change in frequency and number of GI events

    Measured: Up to 10 months

Timeline

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

  1. First posted5 Nov 2015 (estimated)
  2. Study startJan 2005
  3. Primary completionSep 2006
  4. Study completionSep 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
545 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02598453
Sponsor's protocol ID
ML18058
Status last verified
Nov 2016
First submitted
4 Nov 2015
Last updated
2 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ibandronate in people with Postmenopausal Osteoporosis, run by Hoffmann-La Roche at 60 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 2 inclusion and 4 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percentage of participants who have greater than or equal to (>=) 75 percent (%) adherence using either monthly oral ibandronate or quarterly intravenous (IV) ibandronate (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 NCT02598453.

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 2 Nov 2016.

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