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

Primary Purpose

Postmenopausal Osteoporosis

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Ibandronate

About this trial

This is an interventional treatment trial for Postmenopausal Osteoporosis

Eligibility Criteria

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

Inclusion Criteria:

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)

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Ibandronate IV

Ibandronate Oral

Arm Description

Participants will receive ibandronate 3 mg IV once every 3 months

Participants will receive ibandronate 150 milligrams (mg) tablet once monthly

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Percentage of participants with GI events based on severity

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

Full Information

NCT ID

NCT02598453

First Posted

November 4, 2015

Last Updated

November 1, 2016

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT02598453

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

September 2006 (Actual)

Study Completion Date

September 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

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.

6. Conditions and Keywords

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

Postmenopausal Osteoporosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

545 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ibandronate IV

Arm Type

Experimental

Arm Description

Participants will receive ibandronate 3 mg IV once every 3 months

Arm Title

Ibandronate Oral

Arm Type

Experimental

Arm Description

Participants will receive ibandronate 150 milligrams (mg) tablet once monthly

Intervention Type

Drug

Intervention Name(s)

Ibandronate

Other Intervention Name(s)

Bonviva/Boniva

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Time Frame

12 months

Title

Percentage of participants with GI events based on severity

Time Frame

Up to 10 months

Title

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

Time Frame

Up to 10 months

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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

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

36116

Country

United States

City

Lake Havasu City

State/Province

Arizona

ZIP/Postal Code

86403

Country

United States

City

Paradise Valley

State/Province

Arizona

ZIP/Postal Code

85253

Country

United States

City

Pine Bluff

State/Province

Arkansas

ZIP/Postal Code

71603

Country

United States

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

City

Tacoma

State/Province

California

ZIP/Postal Code

98405

Country

United States

City

Vista

State/Province

California

ZIP/Postal Code

92083

Country

United States

City

Beverly Hills

State/Province

Florida

ZIP/Postal Code

34464

Country

United States

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33901

Country

United States

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32605

Country

United States

City

Miami

State/Province

Florida

ZIP/Postal Code

33186

Country

United States

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

City

Palm Harbor

State/Province

Florida

ZIP/Postal Code

34684

Country

United States

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33409

Country

United States

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30904

Country

United States

City

Coeur D'alene

State/Province

Idaho

ZIP/Postal Code

83814

Country

United States

City

Champaign

State/Province

Illinois

ZIP/Postal Code

61820

Country

United States

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47714

Country

United States

City

Natchitoches

State/Province

Louisiana

ZIP/Postal Code

71457

Country

United States

City

South Portland

State/Province

Maine

ZIP/Postal Code

04106

Country

United States

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202-2689

Country

United States

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48236

Country

United States

City

Chaska

State/Province

Minnesota

ZIP/Postal Code

55318

Country

United States

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64114

Country

United States

City

St Louis

State/Province

Missouri

ZIP/Postal Code

63033

Country

United States

City

Billings

State/Province

Montana

ZIP/Postal Code

59101

Country

United States

City

Broken Bow

State/Province

Nebraska

ZIP/Postal Code

68822

Country

United States

City

Scottsbluff

State/Province

Nebraska

ZIP/Postal Code

69361

Country

United States

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89104

Country

United States

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87106

Country

United States

City

New York

State/Province

New York

ZIP/Postal Code

10003

Country

United States

City

West Haverstraw

State/Province

New York

ZIP/Postal Code

10993

Country

United States

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28209

Country

United States

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27704

Country

United States

City

Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144

Country

United States

City

Winston-salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

City

Bismarck

State/Province

North Dakota

ZIP/Postal Code

58501

Country

United States

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58104

Country

United States

City

Canfield

State/Province

Ohio

ZIP/Postal Code

44406

Country

United States

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43213

Country

United States

City

Mayfield

State/Province

Ohio

ZIP/Postal Code

44143

Country

United States

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

City

Wyomissing

State/Province

Pennsylvania

ZIP/Postal Code

19610

Country

United States

City

Loris

State/Province

South Carolina

ZIP/Postal Code

29569

Country

United States

City

Mount Pleasant

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

City

Sioux Falls

State/Province

South Dakota

ZIP/Postal Code

57105

Country

United States

City

Watertown

State/Province

South Dakota

ZIP/Postal Code

57201

Country

United States

City

Bristol

State/Province

Tennessee

ZIP/Postal Code

37620

Country

United States

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

City

Denton

State/Province

Texas

ZIP/Postal Code

76210

Country

United States

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78238

Country

United States

City

Seguin

State/Province

Texas

ZIP/Postal Code

78155

Country

United States

City

Temple

State/Province

Texas

ZIP/Postal Code

76508

Country

United States

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

Country

United States

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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