Back to resultsA Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.
Primary Purpose
Post-Menopausal Osteoporosis
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
ibandronate [Bonviva/Boniva]
ibandronate [Bonviva/Boniva]
Alendronate
Sponsored by
About this trial
This is an interventional treatment trial for Post-Menopausal Osteoporosis
Eligibility Criteria
Inclusion Criteria:
- female patients, >=60 years of age;
- >=5 years postmenopausal;
- confirmed osteoporosis, at increased risk for renal disease.
Exclusion Criteria:
- inability to stand or sit upright for 30 minutes;
- hypersensitivity to bisphosphonates;
- malignant disease (other than successfully resected basal cell cancer) within previous 10 years, or breast cancer diagnosed within previous 20 years;
- previous administration of an i.v. bisphosphonate;
- oral bisphosphonate treatment other than study medication within 30 days prior to the baseline dosing visit and during the study;
- history of major upper gastrointestinal disease.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
1
2
3
Arm Description
Outcomes
Primary Outcome Measures
Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula)
The primary parameter of the study was the change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patients' actual body surface area) after 9 months (or 40 weeks) of treatment.
Secondary Outcome Measures
Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula)
Change (mL/min) from baseline in actual GFR (using Cockcroft-Gault [CG] formula) after 9 months (or 40 weeks) of treatment.
Relative Change From Baseline in Actual GFR (Using Abbreviated MDRD Formula)
Change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patient's actual body surface area) after 9 months (or 40 weeks) of treatment.
Relative Change From Baseline in Actual GFR (Using CG Formula)
Change (mL/min) from baseline in actual GFR (CG formula using the patient's actual body surface area) after 9 months (or 40 weeks) of treatment.
Absolute Change From Baseline in Mean Serum Creatinine.
Relative Change From Baseline in Mean Serum Creatinine.
Absolute Change From Baseline in Urine Albumin-to-Creatinine Ratio.
Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio.
The relative change from baseline in this case is positively skewed (while the absolute change is not) and the means tends to more positive values.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00503113
Brief Title
A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.
Official Title
A Randomized, Open Label Study Evaluating the Effect on Renal Function of Intravenous Bonviva Given by Injection or Infusion, Compared With Oral Alendronate, in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This 3 arm study will evaluate renal safety after administration of an intravenous (iv) injection or infusion of Bonviva, compared to oral alendronate, in patients with postmenopausal osteoporosis, at increased risk of renal disease. Patients will be randomized to receive Bonviva 3mg intravenous (iv) by a) injection or b) infusion once every 3 months, or alendronate 70mg per oral (po) weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ 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
Randomized
Enrollment
801 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
ibandronate [Bonviva/Boniva]
Intervention Description
3mg intravenous (iv) injection every 3 months
Intervention Type
Drug
Intervention Name(s)
ibandronate [Bonviva/Boniva]
Intervention Description
3mg intravenous (iv) infusion every 3 months
Intervention Type
Drug
Intervention Name(s)
Alendronate
Intervention Description
70mg per oral (po) weekly
Primary Outcome Measure Information:
Title
Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula)
Description
The primary parameter of the study was the change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patients' actual body surface area) after 9 months (or 40 weeks) of treatment.
Time Frame
Baseline and 9 months
Secondary Outcome Measure Information:
Title
Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula)
Description
Change (mL/min) from baseline in actual GFR (using Cockcroft-Gault [CG] formula) after 9 months (or 40 weeks) of treatment.
Time Frame
Baseline and 9 months
Title
Relative Change From Baseline in Actual GFR (Using Abbreviated MDRD Formula)
Description
Change (mL/min) from baseline in actual GFR (abbreviated MDRD formula using the patient's actual body surface area) after 9 months (or 40 weeks) of treatment.
Time Frame
Baseline and 9 months
Title
Relative Change From Baseline in Actual GFR (Using CG Formula)
Description
Change (mL/min) from baseline in actual GFR (CG formula using the patient's actual body surface area) after 9 months (or 40 weeks) of treatment.
Time Frame
Baseline and 9 months
Title
Absolute Change From Baseline in Mean Serum Creatinine.
Time Frame
Baseline and 9 months
Title
Relative Change From Baseline in Mean Serum Creatinine.
Time Frame
Baseline and 9 months
Title
Absolute Change From Baseline in Urine Albumin-to-Creatinine Ratio.
Time Frame
Baseline and 9 months
Title
Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio.
Description
The relative change from baseline in this case is positively skewed (while the absolute change is not) and the means tends to more positive values.
Time Frame
Baseline and 9 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
female patients, >=60 years of age;
>=5 years postmenopausal;
confirmed osteoporosis, at increased risk for renal disease.
Exclusion Criteria:
inability to stand or sit upright for 30 minutes;
hypersensitivity to bisphosphonates;
malignant disease (other than successfully resected basal cell cancer) within previous 10 years, or breast cancer diagnosed within previous 20 years;
previous administration of an i.v. bisphosphonate;
oral bisphosphonate treatment other than study medication within 30 days prior to the baseline dosing visit and during the study;
history of major upper gastrointestinal disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80227
Country
United States
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66604
Country
United States
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
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
58103
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45224
Country
United States
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
City
Buenos Aires
ZIP/Postal Code
B1878DVB
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1012-CFed
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1117ABH
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1128AAF
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1405BCH
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1425 AWC
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1425AGC
Country
Argentina
City
Cordoba
ZIP/Postal Code
X5000BNB
Country
Argentina
City
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
City
Brasilia
ZIP/Postal Code
71625-009
Country
Brazil
City
Curitiba
ZIP/Postal Code
80030-110
Country
Brazil
City
Goiania
ZIP/Postal Code
74110-120
Country
Brazil
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
City
Rio de Janeiro
ZIP/Postal Code
22271-100
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
04266-010
Country
Brazil
City
Vitoria
ZIP/Postal Code
29055-450
Country
Brazil
City
Guadalajara
ZIP/Postal Code
44629
Country
Mexico
City
Mexico City
ZIP/Postal Code
11000
Country
Mexico
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
City
Obregon
ZIP/Postal Code
85000
Country
Mexico
City
San Jerónimo Chicahualco
ZIP/Postal Code
52170
Country
Mexico
City
Durban
ZIP/Postal Code
3630
Country
South Africa
City
Johannesburg
ZIP/Postal Code
2196
Country
South Africa
City
Parow
ZIP/Postal Code
7500
Country
South Africa
City
Port Elizabeth
ZIP/Postal Code
6001
Country
South Africa
City
Somerset West
ZIP/Postal Code
7130
Country
South Africa
City
Basel
ZIP/Postal Code
4055
Country
Switzerland
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
34231877
Citation
Hara T, Hijikata Y, Matsubara Y, Watanabe N. Pharmacological interventions versus placebo, no treatment or usual care for osteoporosis in people with chronic kidney disease stages 3-5D. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013424. doi: 10.1002/14651858.CD013424.pub2.
Results Reference
derived
Learn more about this trial
A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.
We'll reach out to this number within 24 hrs