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

This study has been completed.

Sponsor:

Information provided by:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00503113

First received: July 17, 2007

Last updated: May 17, 2011

Last verified: May 2011

History of Changes

Results First Received: March 31, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Post-Menopausal Osteoporosis
Interventions:	Drug: ibandronate [Bonviva/Boniva] Drug: Alendronate

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

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

Participant Flow: Overall Study

	Ibandronate 3 mg Injection	Ibandronate 3 mg Infusion	Alendronate 70 mg Oral
STARTED	268	264	269
Intent to Treat Population (ITT)	262	261	268
Per Protocol Population (PP)	246	243	241
Safety Population	263	263	267
COMPLETED	235	236	241
NOT COMPLETED	33	28	28

Baseline Characteristics

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Reporting Groups

	Description
Ibandronate 3 mg Injection	Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
Ibandronate 3 mg Infusion	Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
Alendronate 70 mg Oral	Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
Total	Total of all reporting groups

Baseline Measures

	Ibandronate 3 mg Injection	Ibandronate 3 mg Infusion	Alendronate 70 mg Oral	Total
Number of Participants [units: participants]	263	263	267	793
Age [units: years] Mean ± Standard Deviation	71.7 ± 6.77	71.5 ± 5.89	71.7 ± 6.3	71.6 ± 6.32
Gender [units: participants]
Female	263	263	267	793
Male	0	0	0	0

Outcome Measures

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1. Primary:

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

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2. Secondary:

Absolute Change From Baseline in Actual GFR (Using Cockcroft-Gault [CG] Formula) [ Time Frame: Baseline and 9 months ]

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3. Secondary:

Relative Change From Baseline in Actual GFR (Using Abbreviated MDRD Formula) [ Time Frame: Baseline and 9 months ]

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4. Secondary:

Relative Change From Baseline in Actual GFR (Using CG Formula) [ Time Frame: Baseline and 9 months ]

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5. Secondary:

Absolute Change From Baseline in Mean Serum Creatinine. [ Time Frame: Baseline and 9 months ]

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6. Secondary:

Relative Change From Baseline in Mean Serum Creatinine. [ Time Frame: Baseline and 9 months ]

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7. Secondary:

Absolute Change From Baseline in Urine Albumin-to-Creatinine Ratio. [ Time Frame: Baseline and 9 months ]

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8. Secondary:

Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio. [ Time Frame: Baseline and 9 months ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	AEs are considered to have occurred ‘On treatment’, defined as first dose and up 106 days after last dose if patient’s actual treatment is ibandronate, or up to 22 days after last dose if patient’s actual treatment is the alendronate.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	2.0%

Reporting Groups

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

Other Adverse Events

	Ibandronate 3 mg Injection	Ibandronate 3 mg Infusion	Alendronate 70 mg Oral
Total, other (not including serious) adverse events
# participants affected / at risk	196/263	190/263	191/267
Blood and lymphatic system disorders
Anaemia ^{* 1}
# participants affected / at risk	8/263 (3.04%)	9/263 (3.42%)	5/267 (1.87%)
Gastrointestinal disorders
Diarrhoea ^{* 1}
# participants affected / at risk	7/263 (2.66%)	11/263 (4.18%)	19/267 (7.12%)
Abdominal Pain Upper ^{* 1}
# participants affected / at risk	0/263 (0.00%)	9/263 (3.42%)	13/267 (4.87%)
Nausea ^{* 1}
# participants affected / at risk	10/263 (3.80%)	10/263 (3.80%)	10/267 (3.75%)
Constipation ^{* 1}
# participants affected / at risk	8/263 (3.04%)	9/263 (3.42%)	5/267 (1.87%)
Gastritis ^{* 1}
# participants affected / at risk	5/263 (1.90%)	8/263 (3.04%)	7/267 (2.62%)
Vomiting ^{* 1}
# participants affected / at risk	8/263 (3.04%)	7/263 (2.66%)	4/267 (1.50%)
Abdominal Pain ^{* 1}
# participants affected / at risk	6/263 (2.28%)	7/263 (2.66%)	4/267 (1.50%)
Gastroesophageal Reflux Disease ^{* 1}
# participants affected / at risk	6/263 (2.28%)	0/263 (0.00%)	8/267 (3.00%)
Haemorrhoids ^{* 1}
# participants affected / at risk	7/263 (2.66%)	1/263 (0.38%)	1/267 (0.37%)
General disorders
Influenza Like Illness ^{* 1}
# participants affected / at risk	15/263 (5.70%)	14/263 (5.32%)	1/267 (0.37%)
Oedema Peripheral ^{* 1}
# participants affected / at risk	12/263 (4.56%)	6/263 (2.28%)	12/267 (4.49%)
Pain ^{* 1}
# participants affected / at risk	6/263 (2.28%)	9/263 (3.42%)	2/267 (0.75%)
Infections and infestations
Influenza ^{* 1}
# participants affected / at risk	37/263 (14.07%)	32/263 (12.17%)	30/267 (11.24%)
Nasopharyngitis ^{* 1}
# participants affected / at risk	12/263 (4.56%)	12/263 (4.56%)	8/267 (3.00%)
Bronchitis ^{* 1}
# participants affected / at risk	10/263 (3.80%)	11/263 (4.18%)	10/267 (3.75%)
Urinary Tract Infection ^{* 1}
# participants affected / at risk	9/263 (3.42%)	10/263 (3.80%)	11/267 (4.12%)
Gastroenteritis ^{* 1}
# participants affected / at risk	3/263 (1.14%)	11/263 (4.18%)	9/267 (3.37%)
Upper Respiratory Tract Infection ^{* 1}
# participants affected / at risk	5/263 (1.90%)	7/263 (2.66%)	8/267 (3.00%)
Labyrinthitis ^{* 1}
# participants affected / at risk	7/263 (2.66%)	3/263 (1.14%)	6/267 (2.25%)
Sinusitis ^{* 1}
# participants affected / at risk	4/263 (1.52%)	4/263 (1.52%)	6/267 (2.25%)
Injury, poisoning and procedural complications
Fall ^{* 1}
# participants affected / at risk	13/263 (4.94%)	8/263 (3.04%)	3/267 (1.12%)
Investigations
Glomerular Filtration Rate Decreased ^{* 1}
# participants affected / at risk	2/263 (0.76%)	3/263 (1.14%)	11/267 (4.12%)
Metabolism and nutrition disorders
Dyslipidemia ^{* 1}
# participants affected / at risk	2/263 (0.76%)	8/263 (3.04%)	10/267 (3.75%)
Hypercholesterolaemia ^{* 1}
# participants affected / at risk	3/263 (1.14%)	4/263 (1.52%)	7/267 (2.62%)
Musculoskeletal and connective tissue disorders
Back Pain ^{* 1}
# participants affected / at risk	26/263 (9.89%)	29/263 (11.03%)	25/267 (9.36%)
Arthralgia ^{* 1}
# participants affected / at risk	22/263 (8.37%)	28/263 (10.65%)	27/267 (10.11%)
Pain in Extremity ^{* 1}
# participants affected / at risk	22/263 (8.37%)	23/263 (8.75%)	21/267 (7.87%)
Myalgia ^{* 1}
# participants affected / at risk	22/263 (8.37%)	14/263 (5.32%)	6/267 (2.25%)
Musculoskeletal Pain ^{* 1}
# participants affected / at risk	19/263 (7.22%)	15/263 (5.70%)	7/267 (2.62%)
Osteoarthritis ^{* 1}
# participants affected / at risk	6/263 (2.28%)	7/263 (2.66%)	13/267 (4.87%)
Bone Pain ^{* 1}
# participants affected / at risk	7/263 (2.66%)	7/263 (2.66%)	2/267 (0.75%)
Neck Pain ^{* 1}
# participants affected / at risk	6/263 (2.28%)	5/263 (1.90%)	5/267 (1.87%)
Nervous system disorders
Dizziness ^{* 1}
# participants affected / at risk	19/263 (7.22%)	12/263 (4.56%)	9/267 (3.37%)
Headache ^{* 1}
# participants affected / at risk	14/263 (5.32%)	15/263 (5.70%)	6/267 (2.25%)
Sciatica ^{* 1}
# participants affected / at risk	6/263 (2.28%)	7/263 (2.66%)	5/267 (1.87%)
Psychiatric disorders
Anxiety ^{* 1}
# participants affected / at risk	5/263 (1.90%)	10/263 (3.80%)	10/267 (3.75%)
Depression ^{* 1}
# participants affected / at risk	11/263 (4.18%)	8/263 (3.04%)	5/267 (1.87%)
Respiratory, thoracic and mediastinal disorders
Cough ^{* 1}
# participants affected / at risk	14/263 (5.32%)	5/263 (1.90%)	17/267 (6.37%)
Dyspepsia ^{* 1}
# participants affected / at risk	5/263 (1.90%)	11/263 (4.18%)	17/267 (6.37%)
Asthma ^{* 1}
# participants affected / at risk	5/263 (1.90%)	6/263 (2.28%)	2/267 (0.75%)
Vascular disorders
Hypertension ^{* 1}
# participants affected / at risk	23/263 (8.75%)	28/263 (10.65%)	16/267 (5.99%)

*	Events were collected by non-systematic assessment
1	Term from vocabulary, MedDRA (12.0)

More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Medical Communications
Organization: Hoffman-LaRoche
phone: 800-821-8590

No publications provided

Responsible Party:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00503113 History of Changes
Other Study ID Numbers:	BA20341
Study First Received:	July 17, 2007
Results First Received:	March 31, 2011
Last Updated:	May 17, 2011
Health Authority:	United States: Food and Drug Administration

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