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

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Completed

CT.gov ID

NCT00503113

Collaborator

(none)

801

Enrollment

Locations

Arms

Duration (Months)

18.2

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Post-Menopausal Osteoporosis	Drug: ibandronate [Bonviva/Boniva] Drug: ibandronate [Bonviva/Boniva] Drug: Alendronate	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

801 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jul 1, 2007

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: ibandronate [Bonviva/Boniva] 3mg intravenous (iv) injection every 3 months
Experimental: 2	Drug: ibandronate [Bonviva/Boniva] 3mg intravenous (iv) infusion every 3 months
Active Comparator: 3	Drug: Alendronate 70mg per oral (po) weekly

Arm

Intervention/Treatment

Experimental: 1

Drug: ibandronate [Bonviva/Boniva]

3mg intravenous (iv) injection every 3 months

Experimental: 2

Drug: ibandronate [Bonviva/Boniva]

3mg intravenous (iv) infusion every 3 months

Active Comparator: 3

Drug: Alendronate

70mg per oral (po) weekly

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Birmingham	Alabama	United States	35294
2	Riverside	California	United States	92505
3	Lakewood	Colorado	United States	80227
4	West Palm Beach	Florida	United States	33401
5	Gainesville	Georgia	United States	30501
6	Topeka	Kansas	United States	66604
7	Bethesda	Maryland	United States	20817
8	Omaha	Nebraska	United States	68131
9	Albuquerque	New Mexico	United States	87106
10	Morehead City	North Carolina	United States	28557
11	Bismarck	North Dakota	United States	58501
12	Fargo	North Dakota	United States	58103
13	Cincinnati	Ohio	United States	45224
14	Duncansville	Pennsylvania	United States	16635
15	Norfolk	Virginia	United States	23502
16	Buenos Aires		Argentina	B1878DVB
17	Buenos Aires		Argentina	C1012-CFed
18	Buenos Aires		Argentina	C1117ABH
19	Buenos Aires		Argentina	C1128AAF
20	Buenos Aires		Argentina	C1405BCH
21	Buenos Aires		Argentina	C1425 AWC
22	Buenos Aires		Argentina	C1425AGC
23	Cordoba		Argentina	X5000BNB
24	Santa Fe		Argentina	2000
25	Brasilia		Brazil	71625-009
26	Curitiba		Brazil	80030-110
27	Goiania		Brazil	74110-120
28	Porto Alegre		Brazil	90610-000
29	Rio de Janeiro		Brazil	22271-100
30	Sao Paulo		Brazil	04266-010
31	Vitoria		Brazil	29055-450
32	Guadalajara		Mexico	44629
33	Mexico City		Mexico	11000
34	Monterrey		Mexico	64460
35	Obregon		Mexico	85000
36	San Jerónimo Chicahualco		Mexico	52170
37	Durban		South Africa	3630
38	Johannesburg		South Africa	2196
39	Parow		South Africa	7500
40	Port Elizabeth		South Africa	6001
41	Somerset West		South Africa	7130
42	Basel		Switzerland	4055
43	Bern		Switzerland	3010
44	Zurich		Switzerland	8091

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00503113

Other Study ID Numbers:

BA20341

First Posted:

Jul 18, 2007

Last Update Posted:

Jun 17, 2011

Last Verified:

May 1, 2011

Additional relevant MeSH terms:

Osteoporosis

Osteoporosis, Postmenopausal

Alendronate

Ibandronic Acid

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail	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.

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

Arm/Group Title	Ibandronate 3 mg Injection	Ibandronate 3 mg Infusion	Alendronate 70 mg Oral	Total
Arm/Group Description	Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.	Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.	Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).	Total of all reporting groups
Overall Participants	263	263	267	793
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71.7 (6.77)	71.5 (5.89)	71.7 (6.3)	71.6 (6.32)
Sex: Female, Male (Count of Participants)
Female	263 100%	263 100%	267 100%	793 100%
Male	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description
Per Protocol (PP) Population

Arm/Group Title	Ibandronate 3 mg Injection	Ibandronate 3 mg Infusion	Alendronate 70 mg Oral
Arm/Group Description	Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.	Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.	Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
Measure Participants	246	243	241
Baseline	72.5 (18.25)	71.5 (18.07)	70.5 (16.67)
Change from baseline at 9 months (n=233,232,225)	-1.3 (7.14)	-0.5 (7.86)	-1.6 (5.89)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description
PP Population

Arm/Group Title	Ibandronate 3 mg Injection	Ibandronate 3 mg Infusion	Alendronate 70 mg Oral
Arm/Group Description	Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.	Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.	Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
Measure Participants	246	243	241
Baseline	65.0 (19.37)	62.9 (18.22)	62.0 (16.67)
Change from Baseline at 9 months (N=233,232,225)	-1.6 (5.89)	-1.0 (6.44)	-1.9 (4.84)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description
PP Population

Arm/Group Title	Ibandronate 3 mg Injection	Ibandronate 3 mg Infusion	Alendronate 70 mg Oral
Arm/Group Description	Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.	Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.	Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
Measure Participants	246	243	241
Baseline	72.5 (18.25)	71.5 (18.07)	70.5 (16.67)
Relative Change at 9 month (n= 233, 232, 225)	-1.4 (10.01)	-0.2 (10.73)	-2.1 (8.64)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description
PP Population

Arm/Group Title	Ibandronate 3 mg Injection	Ibandronate 3 mg Infusion	Alendronate 70 mg Oral
Arm/Group Description	Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.	Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.	Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
Measure Participants	246	243	241
Baseline	65.0 (19.37)	62.9 (18.22)	62.0 (16.76)
Relative Change at 9 month (n=233,232,225)	-2.3 (9.22)	-1.3 (9.55)	-2.8 (7.97)

5. Secondary Outcome

Title	Absolute Change From Baseline in Mean Serum Creatinine.
Description
Time Frame	Baseline and 9 months

Outcome Measure Data

Analysis Population Description
PP Population

Arm/Group Title	Ibandronate 3 mg Injection	Ibandronate 3 mg Infusion	Alendronate 70 mg Oral
Arm/Group Description	Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.	Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.	Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
Measure Participants	246	243	241
Baseline	0.8 (0.17)	0.8 (0.16)	0.8 (0.16)
Change from Baseline at 9 months (n=233,232,225)	0.0 (0.08)	0.0 (0.08)	0.0 (0.07)

6. Secondary Outcome

Title	Relative Change From Baseline in Mean Serum Creatinine.
Description
Time Frame	Baseline and 9 months

Outcome Measure Data

Analysis Population Description
PP Population

Arm/Group Title	Ibandronate 3 mg Injection	Ibandronate 3 mg Infusion	Alendronate 70 mg Oral
Arm/Group Description	Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.	Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.	Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
Measure Participants	246	243	241
Baseline	0.8 (0.17)	0.8 (0.16)	0.8 (0.16)
Relative Change at 9 months (n=233,232,225)	1.7 (8.87)	0.8 (8.87)	2.2 (8.06)

7. Secondary Outcome

Title	Absolute Change From Baseline in Urine Albumin-to-Creatinine Ratio.
Description
Time Frame	Baseline and 9 months

Outcome Measure Data

Analysis Population Description
PP Population

Arm/Group Title	Ibandronate 3 mg Injection	Ibandronate 3 mg Infusion	Alendronate 70 mg Oral
Arm/Group Description	Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.	Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.	Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
Measure Participants	246	243	241
Baseline	16.0 (17.30)	14.1 (15.22)	16.1 (19.11)
Change from Baseline at 9 months (n=233,232,225)	-0.8 (18.54)	0.5 (14.70)	1.4 (22.99)

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description
PP Population

Arm/Group Title	Ibandronate 3 mg Injection	Ibandronate 3 mg Infusion	Alendronate 70 mg Oral
Arm/Group Description	Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.	Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.	Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
Measure Participants	246	243	241
Baseline	16.0 (17.30)	14.1 (15.22)	16.1 (19.11)
Relative Change at 9 month (n=233,232,225)	21.6 (120.98)	15.6 (62.32)	28.3 (116.71)

Adverse Events

	Ibandronate 3 mg Injection		Ibandronate 3 mg Infusion		Alendronate 70 mg Oral
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.
Adverse Event Reporting Description

Arm/Group Title	Ibandronate 3 mg Injection		Ibandronate 3 mg Infusion		Alendronate 70 mg Oral
Arm/Group Description	Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.		Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.		Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Ibandronate 3 mg Injection		Ibandronate 3 mg Infusion		Alendronate 70 mg Oral
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/263 (7.2%)		15/263 (5.7%)		13/267 (4.9%)
Blood and lymphatic system disorders
Autoimmune Thrombocytopenia	0/263 (0%)		1/263 (0.4%)		0/267 (0%)
Cardiac disorders
Atrial Fibrillation	1/263 (0.4%)		1/263 (0.4%)		0/267 (0%)
Cardiac Failure Congestive	2/263 (0.8%)		0/263 (0%)		0/267 (0%)
Acute Coronary Syndrome	0/263 (0%)		1/263 (0.4%)		0/267 (0%)
Angina Pectoris	0/263 (0%)		1/263 (0.4%)		0/267 (0%)
Conduction Disorder	0/263 (0%)		1/263 (0.4%)		0/267 (0%)
Myocardial Infarction	1/263 (0.4%)		0/263 (0%)		0/267 (0%)
Supraventricular Tachycardia	0/263 (0%)		0/263 (0%)		1/267 (0.4%)
Gastrointestinal disorders
Abdominal Pain	1/263 (0.4%)		1/263 (0.4%)		0/267 (0%)
Haematochezia	1/263 (0.4%)		0/263 (0%)		0/267 (0%)
Nausea	0/263 (0%)		1/263 (0.4%)		0/267 (0%)
Pancreatitis Acute	1/263 (0.4%)		0/263 (0%)		0/267 (0%)
Peptic Ulcer Perforation	0/263 (0%)		1/263 (0.4%)		0/267 (0%)
Small Intestinal Obstruction	1/263 (0.4%)		0/263 (0%)		0/267 (0%)
Vomiting	0/263 (0%)		1/263 (0.4%)		0/267 (0%)
Hepatobiliary disorders
Cholecystitis	0/263 (0%)		1/263 (0.4%)		1/267 (0.4%)
Cholecystitis Acute	0/263 (0%)		0/263 (0%)		1/267 (0.4%)
Cholelithiasis	0/263 (0%)		0/263 (0%)		1/267 (0.4%)
Infections and infestations
Pneumonia	1/263 (0.4%)		1/263 (0.4%)		1/267 (0.4%)
Abdominal Abscess	0/263 (0%)		0/263 (0%)		1/267 (0.4%)
Gastroenteritis	0/263 (0%)		0/263 (0%)		1/267 (0.4%)
Herpes Zoster	0/263 (0%)		1/263 (0.4%)		0/267 (0%)
Pyelonephritis	0/263 (0%)		0/263 (0%)		1/267 (0.4%)
Urinary Tract Infection	0/263 (0%)		1/263 (0.4%)		0/267 (0%)
Injury, poisoning and procedural complications
Femur Fracture	3/263 (1.1%)		1/263 (0.4%)		4/267 (1.5%)
Femoral Neck Fracture	3/263 (1.1%)		1/263 (0.4%)		1/267 (0.4%)
Ankle Fracture	0/263 (0%)		0/263 (0%)		1/267 (0.4%)
Fall	0/263 (0%)		1/263 (0.4%)		0/267 (0%)
Head Injury	0/263 (0%)		1/263 (0.4%)		0/267 (0%)
Multiple Drug Overdose Accidental	0/263 (0%)		0/263 (0%)		1/267 (0.4%)
Multiple Fractures	0/263 (0%)		1/263 (0.4%)		0/267 (0%)
Traumatic Brain Injury	0/263 (0%)		1/263 (0.4%)		0/267 (0%)
Vascular Pseudoaneurysm	0/263 (0%)		1/263 (0.4%)		0/267 (0%)
Metabolism and nutrition disorders
Electrolyte Imbalance	0/263 (0%)		0/263 (0%)		1/267 (0.4%)
Hyponatraemia	0/263 (0%)		0/263 (0%)		1/267 (0.4%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	2/263 (0.8%)		0/263 (0%)		2/267 (0.7%)
Back Pain	1/263 (0.4%)		0/263 (0%)		0/267 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer	2/263 (0.8%)		0/263 (0%)		0/267 (0%)
Breast Cancer Stage II	0/263 (0%)		0/263 (0%)		1/267 (0.4%)
Colon Cancer	0/263 (0%)		0/263 (0%)		1/267 (0.4%)
Lymphoma	0/263 (0%)		1/263 (0.4%)		0/267 (0%)
Nervous system disorders
Dizziness	1/263 (0.4%)		0/263 (0%)		0/267 (0%)
Hemiparesis	1/263 (0.4%)		0/263 (0%)		0/267 (0%)
Ischemic Stroke	1/263 (0.4%)		0/263 (0%)		0/267 (0%)
Ruptured Cerebral Aneurysm	0/263 (0%)		0/263 (0%)		1/267 (0.4%)
Senile Dementia	0/263 (0%)		1/263 (0.4%)		0/267 (0%)
Subarachnoid Haemorrhage	1/263 (0.4%)		0/263 (0%)		0/267 (0%)
Reproductive system and breast disorders
Breast Mass	0/263 (0%)		1/263 (0.4%)		0/267 (0%)
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease	0/263 (0%)		1/263 (0.4%)		1/267 (0.4%)
Asthma	0/263 (0%)		0/263 (0%)		1/267 (0.4%)
Haemoptysis	1/263 (0.4%)		0/263 (0%)		0/267 (0%)
Pulmonary Embolism	1/263 (0.4%)		0/263 (0%)		0/267 (0%)
Vascular disorders
Hypertensive Crisis	0/263 (0%)		1/263 (0.4%)		0/267 (0%)
Temporal Arteritis	0/263 (0%)		1/263 (0.4%)		0/267 (0%)
Other (Not Including Serious) Adverse Events
	Ibandronate 3 mg Injection		Ibandronate 3 mg Infusion		Alendronate 70 mg Oral
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	196/263 (74.5%)		190/263 (72.2%)		191/267 (71.5%)
Blood and lymphatic system disorders
Anaemia	8/263 (3%)		9/263 (3.4%)		5/267 (1.9%)
Gastrointestinal disorders
Diarrhoea	7/263 (2.7%)		11/263 (4.2%)		19/267 (7.1%)
Abdominal Pain Upper	0/263 (0%)		9/263 (3.4%)		13/267 (4.9%)
Nausea	10/263 (3.8%)		10/263 (3.8%)		10/267 (3.7%)
Constipation	8/263 (3%)		9/263 (3.4%)		5/267 (1.9%)
Gastritis	5/263 (1.9%)		8/263 (3%)		7/267 (2.6%)
Vomiting	8/263 (3%)		7/263 (2.7%)		4/267 (1.5%)
Abdominal Pain	6/263 (2.3%)		7/263 (2.7%)		4/267 (1.5%)
Gastroesophageal Reflux Disease	6/263 (2.3%)		0/263 (0%)		8/267 (3%)
Haemorrhoids	7/263 (2.7%)		1/263 (0.4%)		1/267 (0.4%)
General disorders
Influenza Like Illness	15/263 (5.7%)		14/263 (5.3%)		1/267 (0.4%)
Oedema Peripheral	12/263 (4.6%)		6/263 (2.3%)		12/267 (4.5%)
Pain	6/263 (2.3%)		9/263 (3.4%)		2/267 (0.7%)
Infections and infestations
Influenza	37/263 (14.1%)		32/263 (12.2%)		30/267 (11.2%)
Nasopharyngitis	12/263 (4.6%)		12/263 (4.6%)		8/267 (3%)
Bronchitis	10/263 (3.8%)		11/263 (4.2%)		10/267 (3.7%)
Urinary Tract Infection	9/263 (3.4%)		10/263 (3.8%)		11/267 (4.1%)
Gastroenteritis	3/263 (1.1%)		11/263 (4.2%)		9/267 (3.4%)
Upper Respiratory Tract Infection	5/263 (1.9%)		7/263 (2.7%)		8/267 (3%)
Labyrinthitis	7/263 (2.7%)		3/263 (1.1%)		6/267 (2.2%)
Sinusitis	4/263 (1.5%)		4/263 (1.5%)		6/267 (2.2%)
Injury, poisoning and procedural complications
Fall	13/263 (4.9%)		8/263 (3%)		3/267 (1.1%)
Investigations
Glomerular Filtration Rate Decreased	2/263 (0.8%)		3/263 (1.1%)		11/267 (4.1%)
Metabolism and nutrition disorders
Dyslipidemia	2/263 (0.8%)		8/263 (3%)		10/267 (3.7%)
Hypercholesterolaemia	3/263 (1.1%)		4/263 (1.5%)		7/267 (2.6%)
Musculoskeletal and connective tissue disorders
Back Pain	26/263 (9.9%)		29/263 (11%)		25/267 (9.4%)
Arthralgia	22/263 (8.4%)		28/263 (10.6%)		27/267 (10.1%)
Pain in Extremity	22/263 (8.4%)		23/263 (8.7%)		21/267 (7.9%)
Myalgia	22/263 (8.4%)		14/263 (5.3%)		6/267 (2.2%)
Musculoskeletal Pain	19/263 (7.2%)		15/263 (5.7%)		7/267 (2.6%)
Osteoarthritis	6/263 (2.3%)		7/263 (2.7%)		13/267 (4.9%)
Bone Pain	7/263 (2.7%)		7/263 (2.7%)		2/267 (0.7%)
Neck Pain	6/263 (2.3%)		5/263 (1.9%)		5/267 (1.9%)
Nervous system disorders
Dizziness	19/263 (7.2%)		12/263 (4.6%)		9/267 (3.4%)
Headache	14/263 (5.3%)		15/263 (5.7%)		6/267 (2.2%)
Sciatica	6/263 (2.3%)		7/263 (2.7%)		5/267 (1.9%)
Psychiatric disorders
Anxiety	5/263 (1.9%)		10/263 (3.8%)		10/267 (3.7%)
Depression	11/263 (4.2%)		8/263 (3%)		5/267 (1.9%)
Respiratory, thoracic and mediastinal disorders
Cough	14/263 (5.3%)		5/263 (1.9%)		17/267 (6.4%)
Dyspepsia	5/263 (1.9%)		11/263 (4.2%)		17/267 (6.4%)
Asthma	5/263 (1.9%)		6/263 (2.3%)		2/267 (0.7%)
Vascular disorders
Hypertension	23/263 (8.7%)		28/263 (10.6%)		16/267 (6%)

Limitations/Caveats

[Not Specified]

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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.

Results Point of Contact

Name/Title	Medical Communications
Organization	Hoffman-LaRoche
Phone	800-821-8590
Email

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00503113

Other Study ID Numbers:

BA20341

First Posted:

Jul 18, 2007

Last Update Posted:

Jun 17, 2011

Last Verified:

May 1, 2011

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

Study Details

Study Description

Brief Summary

Study Design

Arms and Interventions

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Primary Outcome Measures

Secondary Outcome Measures

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Inclusion Criteria:

Exclusion Criteria:

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Study Documents (Full-Text)

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Study Results

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Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

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Results Point of Contact