A Study of Bonviva (Ibandronate) and Alendronate on Renal Function in Postmenopausal Women With Osteoporosis at High Risk for Renal Disease.

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00503113

Enrollment

801

Registered

2007-07-18

Start date

2007-07-31

Completion date

2010-04-30

Last updated

2011-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Menopausal Osteoporosis

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.

Interventions

DRUGibandronate [Bonviva/Boniva]

3mg intravenous (iv) injection every 3 months

DRUGAlendronate

70mg per oral (po) weekly

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

60 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Absolute Change From Baseline in Actual Glomerular Filtration Rate (GFR) (Using Abbreviated Modification of Diet in Renal Disease [MDRD] Formula)	Baseline and 9 months	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

Measure	Time frame	Description
Relative Change From Baseline in Actual GFR (Using Abbreviated MDRD Formula)	Baseline and 9 months	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)	Baseline and 9 months	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.	Baseline and 9 months	—
Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula)	Baseline and 9 months	Change (mL/min) from baseline in actual GFR (using Cockcroft-Gault \[CG\] formula) after 9 months (or 40 weeks) of treatment.
Absolute Change From Baseline in Urine Albumin-to-Creatinine Ratio.	Baseline and 9 months	—
Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio.	Baseline and 9 months	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.
Relative Change From Baseline in Mean Serum Creatinine.	Baseline and 9 months	—

Countries

Argentina, Brazil, Mexico, South Africa, Switzerland, United States

Participant flow

Pre-assignment details

Total 801 participants randomized. Of the randomized patients, 263 who received at least one dose of ibandronate as an injection, 263 who received at least one dose of ibandronate as an infusion and 267 patients who received at least one dose of alendronate had at least one post-baseline assessment and were included in the safety analysis.

Participants by arm

Arm	Count
Ibandronate 3 mg Injection Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.	263
Ibandronate 3 mg Infusion Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.	263
Alendronate 70 mg Oral Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).	267
Total	793

Baseline characteristics

Characteristic	Ibandronate 3 mg Injection	Ibandronate 3 mg Infusion	Alendronate 70 mg Oral	Total
Age Continuous	71.7 years STANDARD_DEVIATION 6.77	71.5 years STANDARD_DEVIATION 5.89	71.7 years STANDARD_DEVIATION 6.3	71.6 years STANDARD_DEVIATION 6.32
Sex: Female, Male Female	263 Participants	263 Participants	267 Participants	793 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	196 / 263	190 / 263	191 / 267
serious Total, serious adverse events	19 / 263	15 / 263	13 / 267

Outcome results

Primary

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.