A Study of Bonviva (Ibandronate) in Women With Post-Menop... | NCT00551174

Label	Type	Description	Intervention Names
1	Experimental		Drug: ibandronate [Bonviva/Boniva]
2	Active Comparator		Drug: ibandronate [Bonviva/Boniva]

Name	Type	Description	Arm Group Labels	Other Names
ibandronate [Bonviva/Boniva]	Drug	3 mg IV every 3 months for 3 years. All patients received a minimum of calcium 500 milligrams/day (upper limit 1500 mg/day) and Vitamin D 400 Internation Units/day (IU/day).

Measure	Description	Time Frame
Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months	Relative change percent(%) from baseline of MA17904 and BM16550 (NCT00048074) in mean lumbar spine (L2-L4) BMD at 12, 24 and 36 months (i.e., 3, 4 and 5 years after initiation of BM16550)- Study MA17940.Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t=12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.	Baseline,12, 24 and 36 months

Measure	Description	Time Frame
Relative Percent Change From Baseline in Mean Total Hip BMD at 12, 24 and 36 Months	Relative change percent (%) from baseline of MA17904 and BM16550 (NCT00048074) in mean total hip BMD at 12, 24 and 36 months (i.e., 3, 4 and 5 years after initiation of BM16550)- Study MA17904. Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t=12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Gainesville	Georgia	30501	United States

ID	Title	Description
FG000	2 mg Ibandronate q2mo	2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
FG001	3 mg Ibandronate q3mo	3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Relative Percent Change From Baseline in Mean Lumbar Spine Bone Mineral Density (BMD) at 12, 24 and 36 Months

Relative change percent(%) from baseline of MA17904 and BM16550 (NCT00048074) in mean lumbar spine (L2-L4) BMD at 12, 24 and 36 months (i.e., 3, 4 and 5 years after initiation of BM16550)- Study MA17940.Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t=12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.

ITT population: 3 mg group = 394, 2 mg group = 362. Analysis populations (AP) for Month 12: 3 mg group = 383, 2 mg group = 348; Month 24: 3 mg group = 374, 2 mg group = 332; Month 36: 3 mg group = 349, 2 mg group = 314.

Posted

Mean

Standard Deviation

Percent change

Baseline,12, 24 and 36 months

ID	Title	Description
OG000	2 mg Ibandronate q2mo	2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
OG001	3 mg Ibandronate q3mo	3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years

Units	Counts
Participants	OG000362 OG001394

Title

Denominators

Categories

Baseline

Title	Measurements
	OG0000.7969± 0.0764 OG0010.7861± 0.0824

Percent Change from Baseline at Month 12

Title	Measurements
	OG000

Secondary

Relative Percent Change From Baseline in Mean Total Hip BMD at 12, 24 and 36 Months

Relative change percent (%) from baseline of MA17904 and BM16550 (NCT00048074) in mean total hip BMD at 12, 24 and 36 months (i.e., 3, 4 and 5 years after initiation of BM16550)- Study MA17904. Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t=12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.

ITT populations: 3 mg group = 394, 2 mg group = 362. Analysis populations (AP) for Month 12: 3 mg group = 381, 2 mg group = 347; Month 24: 3 mg group = 371, 2 mg group = 330; Month 36: 3 mg group = 349, 2 mg group = 314.

Posted

Mean

Standard Deviation

Percent change

Baseline,12, 24 and 36 months

ID	Title	Description
OG000	2 mg Ibandronate q2mo	2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
OG001	3 mg Ibandronate q3mo	3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years

Units	Counts
Participants

Secondary

Relative Percent Change From Baseline in Serum C-telopeptide Crosslinks of Type I Collagen (CTX) at Trough at 6, 12, 24 and 36 Months

Relative percent (%) change from baseline of MA17904 and BM16550 (NCT00048074) in serum C-telopeptide crosslinks of type I collagen (CTX) at trough at 6, 12, 24 and 36 months- Study MA17904. Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t=6, 12, 24 and 36 months. The baseline value is used as a reference to calculate the relative change from baseline.

Per-Protocol population: 3 mg group = 363, 2 mg group = 344. Analysis populations (AP) for Month 6: 3 mg group = 87, 2 mg group: 92; Month 12: 3 mg group = 92, 2 mg group = 92; Month 24: 3 mg group = 83, 2 mg group = 85; Month 36: 3 mg group = 75, 2 mg group = 76.

Posted

Mean

Standard Deviation

Percent change

Baseline, 6, 12, 24 and 36 months (i.e., 2.5, 3, 4 and 5 years after initiation of BM16550)

ID	Title	Description
OG000	2 mg Ibandronate q2mo	2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
OG001	3 mg Ibandronate q3mo	3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years

Units	Counts

Secondary

Relative Percent Change From Baseline in Post-dose Suppression of Serum CTX at 6 Months

Relative percent (%) change from MA17904 baseline of post-dose suppression of serum C-telopeptide crosslinks of type I collagen (CTX) at 6 months- Study MA17904. Percent change=[(measure at time t - measure at baseline)/measure at baseline]*100%, where t= 6 months. The baseline value is used as a reference to calculate the relative change from baseline.

Per-Protocol population: 3 mg group = 363, 2 mg group = 344. Analysis populations (AP) for Month 6: 3 mg group = 89, 2 mg group: 93.

Posted

Mean

Standard Deviation

Percent change

Baseline, 6 months

ID	Title	Description
OG000	2 mg Ibandronate q2mo	2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
OG001	3 mg Ibandronate q3mo	3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0015 affected400 at risk
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Non-systematic Assessment	EG0002 affected381 at risk EG0010 affected400 at risk
Colon Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Non-systematic Assessment	EG0002 affected381 at risk EG0010 affected400 at risk
Radius Fracture	Injury, poisoning and procedural complications	MedDRA (11.1)	Non-systematic Assessment	EG0003 affected381 at risk EG0012 affected400 at risk
Femur Fracture	Injury, poisoning and procedural complications	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0013 affected400 at risk
Femoral Neck Fracture	Injury, poisoning and procedural complications	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0012 affected400 at risk
Ulna Fracture	Injury, poisoning and procedural complications	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0012 affected400 at risk
Lumbar Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA (11.1)	Non-systematic Assessment	EG0002 affected381 at risk EG0010 affected400 at risk
Pneumonia	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0005 affected381 at risk EG0014 affected400 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Non-systematic Assessment	EG0003 affected381 at risk EG0015 affected400 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Non-systematic Assessment	EG0002 affected381 at risk EG0011 affected400 at risk
Foot Deformity	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0012 affected400 at risk
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0012 affected400 at risk
Myocardial Infarction	Cardiac disorders	MedDRA (11.1)	Non-systematic Assessment	EG0006 affected381 at risk EG0010 affected400 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA (11.1)	Non-systematic Assessment	EG0003 affected381 at risk EG0010 affected400 at risk
Myocardial Ischaemia	Cardiac disorders	MedDRA (11.1)	Non-systematic Assessment	EG0002 affected381 at risk EG0011 affected400 at risk
Hiatus Hernia	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0012 affected400 at risk
Transient Ischaemic Attack	Nervous system disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0013 affected400 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0013 affected400 at risk
Sciatica	Nervous system disorders	MedDRA (11.1)	Non-systematic Assessment	EG0002 affected381 at risk EG0010 affected400 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0003 affected381 at risk EG0010 affected400 at risk
Uterine Polyp	Reproductive system and breast disorders	MedDRA (11.1)	Non-systematic Assessment	EG0002 affected381 at risk EG0010 affected400 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0012 affected400 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0012 affected400 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (11.1)	Non-systematic Assessment	EG0003 affected381 at risk EG0010 affected400 at risk
Lung Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0011 affected400 at risk
Ovarian Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0011 affected400 at risk
Rectal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0011 affected400 at risk
Thyroid Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0011 affected400 at risk
Acute Myeloid Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Adenocarcinoma Pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
B-Cell Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Benign Uterine Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Bile Duct Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Endometrial Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Lung Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Myelodysplastic Syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Rectal Cancer Recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Small Cell Lung Cancer Stage Unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Squamous Cell Carcinoma of Skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Thyroid Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Uterine Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Humerus Fracture	Injury, poisoning and procedural complications	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0011 affected400 at risk
Lower Limb Fracture	Injury, poisoning and procedural complications	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0011 affected400 at risk
Ankle Fracture	Injury, poisoning and procedural complications	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Clavicle Fracture	Injury, poisoning and procedural complications	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Foot Fracture	Injury, poisoning and procedural complications	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Hand Fracture	Injury, poisoning and procedural complications	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Joint Dislocation	Injury, poisoning and procedural complications	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Pelvic Fracture	Injury, poisoning and procedural complications	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Rib Fracture	Injury, poisoning and procedural complications	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Spinal Compression Fracture	Injury, poisoning and procedural complications	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Tendon Rupture	Injury, poisoning and procedural complications	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Wrist Fracture	Injury, poisoning and procedural complications	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Appendicitis	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Borrelia Infection	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Breast Abscess	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Bronchopneumonia	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Escherichia Bacteraemia	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Eye Infection	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Gallbladder Empyema	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Gastrointestinal Infection	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Herpes Zoster	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Herpes Zoster Ophthalmic	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Infective Tenosynovitis	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Lower Respiratory Tract Infection	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Osteomyelitis	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Pulmonary Tuberculosis	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Pyelonephritis Acute	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Typhoid Fever	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Urinary Tract Infection	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Urosepsis	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Intervertebral Disc Disorder	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Joint Effusion	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Lumbar Spinal Stenosis	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Muscle Haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Angina Pectoris	Cardiac disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0011 affected400 at risk
Atrial Flutter	Cardiac disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Atrioventricular Block Complete	Cardiac disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Cardiac Discomfort	Cardiac disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Cardio-Respiratory Arrest	Cardiac disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Left Ventricular Failure	Cardiac disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Wolff-Parkinson-White Syndrome	Cardiac disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Duodenal Ulcer	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0011 affected400 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Abdominal Pain Lower	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Colitis Ulcerative	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Constipation	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Diverticulum Intestinal	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Duodenal Ulcer Haemorrhage	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Femoral Hernia	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Gatritis	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Gastrointestinal Disorder	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Inguinal Hernia, Obstructive	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Pancreatitis Necrotising	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Papilla of Vater Stenosis	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Peptic Ulcer Haemorrhage	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Subileus	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Carotid Artery Stenosis	Nervous system disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Cauda Equina Syndrome	Nervous system disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Cerebral Infarction	Nervous system disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Parkinson's Disease	Nervous system disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Presyncope	Nervous system disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Syncope	Nervous system disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0011 affected400 at risk
Acute Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Bronchitis Chronic	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Pulmonary Fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Pulmonary Thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Vaginal Haemorrhage	Reproductive system and breast disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0011 affected400 at risk
Ovarian Cyst	Reproductive system and breast disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Uterine Prolapse	Reproductive system and breast disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Vaginal Prolapse	Reproductive system and breast disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Chest Pain	General disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0011 affected400 at risk
Fatigue	General disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Malaise	General disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Multi-Organ Failure	General disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0011 affected400 at risk
Hypertension	Vascular disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Hypertensive Crisis	Vascular disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Hypotension	Vascular disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Bile Duct Stone	Hepatobiliary disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0011 affected400 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0011 affected400 at risk
Cholangitis	Hepatobiliary disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Urethral Stenosis	Renal and urinary disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Cataract	Eye disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Conjunctivitis	Eye disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Dacryostenosis Acquired	Eye disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Rash Papular	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected381 at risk EG0010 affected400 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Goitre	Endocrine disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Platelet Count Decreased	Investigations	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk
Depression	Psychiatric disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected381 at risk EG0011 affected400 at risk

ID	Term
D010024	Osteoporosis
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D004164	Diphosphonates
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals

ID	Title	Description
BG000	2 mg Ibandronate q2mo	2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
BG001	3 mg Ibandronate q3mo	3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	2 mg Ibandronate q2mo	2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years			90	381	265	381
EG001	3 mg Ibandronate q3mo	3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years			84	400	285	400

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG00079 affected381 at risk EG00167 affected400 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Non-systematic Assessment	EG00064 affected381 at risk EG00171 affected400 at risk
Hypertension	Vascular disorders	MedDRA (11.1)	Non-systematic Assessment	EG00053 affected381 at risk EG00159 affected400 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Non-systematic Assessment	EG00057 affected381 at risk EG00147 affected400 at risk
Influenza	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG00042 affected381 at risk EG00144 affected400 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA (11.1)	Non-systematic Assessment	EG00036 affected381 at risk EG00131 affected400 at risk
Bronchitis	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG00033 affected381 at risk EG00127 affected400 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Non-systematic Assessment	EG00029 affected381 at risk EG00127 affected400 at risk
Urinary Tract Infection	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG00031 affected381 at risk EG00123 affected400 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Non-systematic Assessment	EG00031 affected381 at risk EG00121 affected400 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Non-systematic Assessment	EG00025 affected381 at risk EG00127 affected400 at risk
Pneumonia	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG00021 affected381 at risk EG00124 affected400 at risk
Cystitis	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG00024 affected381 at risk EG00118 affected400 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG00021 affected381 at risk EG00121 affected400 at risk
Cataract	Eye disorders	MedDRA (11.1)	Non-systematic Assessment	EG00019 affected381 at risk EG00121 affected400 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG00020 affected381 at risk EG00120 affected400 at risk
Depression	Psychiatric disorders	MedDRA (11.1)	Non-systematic Assessment	EG00015 affected381 at risk EG00121 affected400 at risk
Dizziness	Nervous system disorders	MedDRA (11.1)	Non-systematic Assessment	EG00021 affected381 at risk EG0018 affected400 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Non-systematic Assessment	EG00020 affected381 at risk EG0018 affected400 at risk