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

February 10, 2016 updated by: Hoffmann-La Roche

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

308

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ponce, Puerto Rico, 00717-1318
      • San Juan, Puerto Rico, 00935
      • San Juan, Puerto Rico, 00927
    • Alabama
      • Montgomery, Alabama, United States, 36111
    • Arizona
      • Chandler, Arizona, United States, 85225
      • Peoria, Arizona, United States, 85381
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
      • Pine Bluff, Arkansas, United States, 71603
    • California
      • Anaheim, California, United States, 92801
      • Beverly Hills, California, United States, 90211
      • Carmichael, California, United States, 95608
    • Delaware
      • Wilmington, Delaware, United States, 19805
    • Florida
      • Deland, Florida, United States, 32720
      • Miami, Florida, United States, 33186
      • Miami, Florida, United States, 33176
      • Palm Habor, Florida, United States, 34684
      • Palm Springs, Florida, United States, 33461
      • West Palm Beach, Florida, United States, 33409
    • Georgia
      • Atlanta, Georgia, United States, 30309
      • Rome, Georgia, United States, 30165
    • Illinois
      • Morton Grove, Illinois, United States, 60053
    • Indiana
      • Indianapolis, Indiana, United States, 46202
    • Iowa
      • Waterloo, Iowa, United States, 50702
    • Maryland
      • Baltimore, Maryland, United States, 21209
      • Hagerstown, Maryland, United States, 21740
      • Reistertown, Maryland, United States, 21136
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654
    • Missouri
      • Jefferson City, Missouri, United States, 65109
      • St Louis, Missouri, United States, 63108
    • Nebraska
      • Omaha, Nebraska, United States, 68131
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
    • New York
      • Bronx, New York, United States, 10461
      • New York, New York, United States, 10016
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
      • Morganton, North Carolina, United States, 28655
      • Raleigh, North Carolina, United States, 27612
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
    • Oregon
      • Medford, Oregon, United States, 97504
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18901
      • Langhorne, Pennsylvania, United States, 19047
      • Philadelphia, Pennsylvania, United States, 19131
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
      • Spartanburg, South Carolina, United States, 29307
    • Tennessee
      • Morristown, Tennessee, United States, 37813
      • Murfreesboro, Tennessee, United States, 37130
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Amarillo, Texas, United States, 79106
      • Fort Worth, Texas, United States, 76101
      • San Antonio, Texas, United States, 78229
      • Texarkana, Texas, United States, 75503
    • Virginia
      • Richmond, Virginia, United States, 23226
    • Washington
      • Tacoma, Washington, United States, 98405
    • Wisconsin
      • Madison, Wisconsin, United States, 53705

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ibandronate Group 1
Participants 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.
Participants will receive oral ibandronate, 150 mg once weekly, for approximately 6 months.
Other Names:
  • Bonviva/Boniva
Experimental: Ibandronate Group 2
Participants will receive a 6-month regimen with oral ibandronate, 150 mg once monthly. Group 2 will not receive a physician consultation.
Participants will receive oral ibandronate, 150 mg once weekly, for approximately 6 months.
Other Names:
  • Bonviva/Boniva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline to Month 6 in Serum C-terminal Telopeptide of Type 1 Collagen (CTX)
Time Frame: Baseline, Month 6
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).
Baseline, Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline to Month 6 in Urine N-terminal Telopeptide of Type 1 Collagen (NTX)
Time Frame: Baseline, Month 6
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).
Baseline, Month 6
Percent Change From Baseline to Month 6 in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)
Time Frame: Baseline, Month 6
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).
Baseline, Month 6
Percent Change From Baseline to Month 6 in Serum Osteocalcin
Time Frame: Baseline, Month 6
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).
Baseline, Month 6
Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (BSAP)
Time Frame: Baseline, Month 6
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).
Baseline, Month 6
Percentage of Participants Who Were "Very Confident" or "Confident" to Items on the Boniva Confidence Scale (BCS) at Month 6
Time Frame: 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.
Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

November 4, 2015

First Submitted That Met QC Criteria

November 4, 2015

First Posted (Estimate)

November 6, 2015

Study Record Updates

Last Update Posted (Estimate)

March 9, 2016

Last Update Submitted That Met QC Criteria

February 10, 2016

Last Verified

February 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Post Menopausal Osteoporosis

Clinical Trials on Ibandronate

3
Subscribe