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A Study of Ibandronate (Bonviva) in Patients With Post-Menopausal Osteoporosis

Primary Purpose

Postmenopausal Osteoporosis

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Alendronate

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:

Ambulatory women
Diagnosis of post-menopausal osteoporosis
Women who have never received bisphosphonate therapy, or who have discontinued daily bisphosphonates at least 3 months prior to study entry

Exclusion Criteria:

Inability to stand or sit in the upright position for greater than or equal to 60 minutes
Allergy to bisphosphonates;
Previous or current treatment with weekly or monthly bisphosphonates, or daily bisphosphonates for the last 3 months prior to study entry

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group A: Ibandronate Then Alendronate

Group B: Alendronate Then Ibandronate

Arm Description

Participants wil receive once-monthly oral ibandronate (150 mg tablet) for 3 months followed by and once-weekly oral alendronate (70 mg tablet) in crossover design for 12 weeks.

Participants will receive once-weekly oral alendronate (70 mg tablet) for 12 weeks followed by once-monthly oral ibandronate (150 mg tablet) for 3 months.

Outcomes

Primary Outcome Measures

Percentage of participants preferring once-monthly dosing of ibandronate over once-weekly dosing of alendronate

Secondary Outcome Measures

Percentage of participants perceiving the once-monthly dosing of ibandronate to be more convenient over once-weekly dosing of alendronate.

Incidence of adverse events

Full Information

NCT ID

NCT02598440

First Posted

November 4, 2015

Last Updated

November 1, 2016

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT02598440

Brief Title

A Study of Ibandronate (Bonviva) in Patients With Post-Menopausal Osteoporosis

Official Title

A Randomized, Open-Label, Muti-Center Study to Investigate Patient Preference on Dosing in Women With Postmenopausal Osteoporosis Treated With Once-Monthly Ibandronate and Once-Weekly Alendronate. A Six Month, Two-Sequence, and Two-Period Crossover Study

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

March 2004 (undefined)

Primary Completion Date

May 2005 (Actual)

Study Completion Date

May 2005 (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 participant-reported preference for either ibandronate or a comparator drug in women with postmenopausal osteoporosis. The anticipated time of study treatment is 6 months, and the target sample size is 338 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

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

341 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A: Ibandronate Then Alendronate

Arm Type

Experimental

Arm Description

Participants wil receive once-monthly oral ibandronate (150 mg tablet) for 3 months followed by and once-weekly oral alendronate (70 mg tablet) in crossover design for 12 weeks.

Arm Title

Group B: Alendronate Then Ibandronate

Arm Type

Experimental

Arm Description

Participants will receive once-weekly oral alendronate (70 mg tablet) for 12 weeks followed by once-monthly oral ibandronate (150 mg tablet) for 3 months.

Intervention Type

Drug

Intervention Name(s)

Alendronate

Intervention Description

Participants wil receive once-weekly oral alendronate (70 mg tablet)

Intervention Type

Drug

Intervention Name(s)

Ibandronate

Other Intervention Name(s)

Bonviva

Intervention Description

Participants wil receive once-monthly oral ibandronate (150 mg tablet)

Primary Outcome Measure Information:

Title

Percentage of participants preferring once-monthly dosing of ibandronate over once-weekly dosing of alendronate

Time Frame

Up to 6 months

Secondary Outcome Measure Information:

Title

Percentage of participants perceiving the once-monthly dosing of ibandronate to be more convenient over once-weekly dosing of alendronate.

Time Frame

Up to 6 months

Title

Incidence of adverse events

Time Frame

Up to approximately 1 year

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ambulatory women Diagnosis of post-menopausal osteoporosis Women who have never received bisphosphonate therapy, or who have discontinued daily bisphosphonates at least 3 months prior to study entry Exclusion Criteria: Inability to stand or sit in the upright position for greater than or equal to 60 minutes Allergy to bisphosphonates; Previous or current treatment with weekly or monthly bisphosphonates, or daily bisphosphonates for the last 3 months prior to study entry

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

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801

Country

United States

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85006

Country

United States

City

Tempe

State/Province

Arizona

ZIP/Postal Code

85282

Country

United States

City

Laguna Woods

State/Province

California

ZIP/Postal Code

92653

Country

United States

City

Mission Viejo

State/Province

California

ZIP/Postal Code

92691

Country

United States

City

Oceanside

State/Province

California

ZIP/Postal Code

92056

Country

United States

City

San Diego

State/Province

California

ZIP/Postal Code

92103-6204

Country

United States

City

San Diego

State/Province

California

ZIP/Postal Code

92108

Country

United States

City

Santa Clarita

State/Province

California

ZIP/Postal Code

91321

Country

United States

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

City

Vista

State/Province

California

ZIP/Postal Code

92084

Country

United States

City

Denver

State/Province

Colorado

ZIP/Postal Code

80202

Country

United States

City

Cromwell

State/Province

Connecticut

ZIP/Postal Code

06416

Country

United States

City

Waterbury

State/Province

Connecticut

ZIP/Postal Code

06708

Country

United States

City

Newark

State/Province

Delaware

ZIP/Postal Code

19713

Country

United States

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

City

Miami

State/Province

Florida

ZIP/Postal Code

33176

Country

United States

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33024

Country

United States

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614

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

Decatur

State/Province

Georgia

ZIP/Postal Code

30033

Country

United States

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

City

South Bend

State/Province

Indiana

ZIP/Postal Code

46601

Country

United States

City

Des Moines

State/Province

Iowa

ZIP/Postal Code

50314

Country

United States

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67207

Country

United States

City

Bangor

State/Province

Maine

ZIP/Postal Code

04401

Country

United States

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21209

Country

United States

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01610

Country

United States

City

Florissant

State/Province

Missouri

ZIP/Postal Code

63031

Country

United States

City

St Louis

State/Province

Missouri

ZIP/Postal Code

63128

Country

United States

City

Reno

State/Province

Nevada

ZIP/Postal Code

89502

Country

United States

City

Princeton

State/Province

New Jersey

ZIP/Postal Code

08540

Country

United States

City

Toms River

State/Province

New Jersey

ZIP/Postal Code

08753

Country

United States

City

Orchard Park

State/Province

New York

ZIP/Postal Code

14127

Country

United States

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27609

Country

United States

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97401

Country

United States

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

City

Erie

State/Province

Pennsylvania

ZIP/Postal Code

16502

Country

United States

City

Erie

State/Province

Pennsylvania

ZIP/Postal Code

16506

Country

United States

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19114

Country

United States

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19148

Country

United States

City

Wyomissing

State/Province

Pennsylvania

ZIP/Postal Code

19610

Country

United States

City

Warwick

State/Province

Rhode Island

ZIP/Postal Code

02886

Country

United States

City

Mount Pleasant

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

City

Dallas

State/Province

Texas

ZIP/Postal Code

75234

Country

United States

City

Houston

State/Province

Texas

ZIP/Postal Code

77024

Country

United States

City

Newport News

State/Province

Virginia

ZIP/Postal Code

23602

Country

United States

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23235

Country

United States

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

City

Seattle

State/Province

Washington

ZIP/Postal Code

98144

Country

United States

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53705

Country

United States

12. IPD Sharing Statement

Learn more about this trial

A Study of Ibandronate (Bonviva) in Patients With Post-Menopausal Osteoporosis

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