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

Primary Purpose

Post Menopausal Osteoporosis

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Ibandronate
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Menopausal Osteoporosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ibandronate Group 1

Ibandronate Group 2

Arm Description

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 a 6-month regimen with oral ibandronate, 150 mg once monthly. Group 2 will not receive a physician consultation.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
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).
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).
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.

Full Information

First Posted
November 4, 2015
Last Updated
February 10, 2016
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02598934
Brief Title
A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Postmenopausal Osteoporosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Menopausal Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
308 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ibandronate Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Ibandronate Group 2
Arm Type
Experimental
Arm Description
Participants will receive a 6-month regimen with oral ibandronate, 150 mg once monthly. Group 2 will not receive a physician consultation.
Intervention Type
Drug
Intervention Name(s)
Ibandronate
Other Intervention Name(s)
Bonviva/Boniva
Intervention Description
Participants will receive oral ibandronate, 150 mg once weekly, for approximately 6 months.
Primary Outcome Measure Information:
Title
Percent Change From Baseline to Month 6 in Serum C-terminal Telopeptide of Type 1 Collagen (CTX)
Description
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).
Time Frame
Baseline, Month 6
Secondary Outcome Measure Information:
Title
Percent Change From Baseline to Month 6 in Urine N-terminal Telopeptide of Type 1 Collagen (NTX)
Description
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).
Time Frame
Baseline, Month 6
Title
Percent Change From Baseline to Month 6 in Serum Procollagen Type 1 N-terminal Propeptide (P1NP)
Description
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).
Time Frame
Baseline, Month 6
Title
Percent Change From Baseline to Month 6 in Serum Osteocalcin
Description
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).
Time Frame
Baseline, Month 6
Title
Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (BSAP)
Description
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).
Time Frame
Baseline, Month 6
Title
Percentage of Participants Who Were "Very Confident" or "Confident" to Items on the Boniva Confidence Scale (BCS) at Month 6
Description
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.
Time Frame
Month 6

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36111
Country
United States
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
City
Pine Bluff
State/Province
Arkansas
ZIP/Postal Code
71603
Country
United States
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19805
Country
United States
City
Deland
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
City
Palm Habor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
City
Palm Springs
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
City
Rome
State/Province
Georgia
ZIP/Postal Code
30165
Country
United States
City
Morton Grove
State/Province
Illinois
ZIP/Postal Code
60053
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
City
Waterloo
State/Province
Iowa
ZIP/Postal Code
50702
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21209
Country
United States
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
City
Reistertown
State/Province
Maryland
ZIP/Postal Code
21136
Country
United States
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
City
Bloomfield
State/Province
New Jersey
ZIP/Postal Code
07003
Country
United States
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
City
Morganton
State/Province
North Carolina
ZIP/Postal Code
28655
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901
Country
United States
City
Langhorne
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19131
Country
United States
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29307
Country
United States
City
Morristown
State/Province
Tennessee
ZIP/Postal Code
37813
Country
United States
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76101
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Texarkana
State/Province
Texas
ZIP/Postal Code
75503
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
City
Ponce
ZIP/Postal Code
00717-1318
Country
Puerto Rico
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

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