A Study of Bonviva (Ibandronate) in Women With Post-Menop... | NCT00081653

Status Module

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	150mg po monthly for 3 years	1
ibandronate [Bonviva/Boniva]

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD	Absolute change from Baseline in mean BMD of the lumbar spine (L2 - L4) measured as grams per square centimeter (g/cm^2). This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 [NCT00081653]).	Baseline and Months 12, 24 and 36
Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD)	BMD was measured by a single dual-energy X-ray absorptiometry (DXA) scan of the lumbar spine (BMD of at least 2 vertebrae [L2-L4] that were not fractured and not affected by osteoarthritis to such a degree that BMD measurement would be compromised) at the time of enrollment and at Months 12, 24 and 36. This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 [NCT00081653]).	Baseline and Months 12, 24 and 36

Secondary Outcomes

Measure	Description	Time Frame
Absolute Change From Baseline in Mean Total Hip BMD	BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones).	Baseline and 12, 24 and 36 months
Relative Percent Change From Baseline in Mean Total Hip BMD

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Loma Linda	California	92357	United States

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Ibandronate 100 Milligrams (mg)	100 mg ibandronate oral (PO) monthly and monthly oral placebo (corresponding to the 150 mg tablet)
FG001	Ibandronate 150 mg	150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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

Secondary

Absolute Change From Baseline in Mean Total Hip BMD

BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones).

ITT Population; n = number of participants analyzed for the given parameter at the specified visit.

Posted

Mean

Standard Deviation

g/cm^2

Baseline and 12, 24 and 36 months

ID	Title	Description
OG000	Ibandronate 100 mg	100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
OG001	Ibandronate 150 mg	150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)

Units	Counts
Participants	OG000347 OG001348

Title

Denominators

Categories

Baseline (n=345,348)

Title	Measurements
	OG0000.7680± 0.1093 OG0010.7862± 0.1112

Month 12 (n=347,346)

Title	Measurements
	OG000

Secondary

Relative Percent Change From Baseline in Mean Total Hip BMD

BMD was measured by a single DXA scan of the hip. Scores between -1 and -2.5 indicate Osteopenia (thin bones). Less than -2.5 indicate Osteoporosis (porous bones).

ITT Population; n = number of participants analyzed for the given parameter at the specified visit.

Posted

Mean

Standard Deviation

percent change in BMD

Baseline, 12, 24 and 36 months

ID	Title	Description
OG000	Ibandronate 100 mg	100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
OG001	Ibandronate 150 mg	150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)

Units	Counts
Participants	OG000

Secondary

Absolute Change From Baseline of Trough Serum CTX

CTX is a measure of bone resorption and is measured as ng/mL. Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values.

ITT population; n = number of participants analyzed for the given parameter at the specified visit.

Posted

Mean

Standard Deviation

ng/mL

Baseline, 6, 12, 24 and 36 months

ID	Title	Description
OG000	Ibandronate 100 mg	100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
OG001	Ibandronate 150 mg	150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)

Units	Counts
Participants	OG000

Primary

Absolute Change From Baseline in Mean Lumbar Spine (L2 - L4) BMD

Absolute change from Baseline in mean BMD of the lumbar spine (L2 - L4) measured as grams per square centimeter (g/cm^2). This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 [NCT00081653]).

ITT population; number (n) equals (=) number of participants analyzed at the specified visit.

Posted

Mean

Standard Deviation

g/cm^2

Baseline and Months 12, 24 and 36

ID	Title	Description
OG000	Ibandronate 100 mg	100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
OG001	Ibandronate 150 mg	150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)

Units	Counts
Participants	OG000

Primary

Relative Percent (%) Change From Baseline in Mean Lumbar Spine (L2 - L4) Bone Mineral Density (BMD)

BMD was measured by a single dual-energy X-ray absorptiometry (DXA) scan of the lumbar spine (BMD of at least 2 vertebrae [L2-L4] that were not fractured and not affected by osteoarthritis to such a degree that BMD measurement would be compromised) at the time of enrollment and at Months 12, 24 and 36. This was baseline of Study MA17903 after two years of treatment in the core study (BM16549 [NCT00081653]).

ITT population: n = number of participants analyzed for the given parameter at the specified visit.

Posted

Mean

Standard Deviation

percent change

Baseline and Months 12, 24 and 36

ID	Title	Description
OG000	Ibandronate 100 mg	100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
OG001	Ibandronate 150 mg	150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)

Units	Counts
Participants

Secondary

Relative Percent Change From Baseline of Trough Serum CTX

CTX is a measure of bone resorption and is measured as nanograms per milliliter (ng/mL). Blood samples for the Month 6 values were collected 6 days after the 6-month dose; therefore, the Month 6 values are not true 'trough' values.

ITT population; n = number of participants analyzed for the given parameter at the specified visit.

Posted

Mean

Standard Deviation

percent change

Baseline, 6,12, 24 and 36 months

ID	Title	Description
OG000	Ibandronate 100 mg	100 mg ibandgronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
OG001	Ibandronate 150 mg	150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0014 affected361 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected358 at risk EG0011 affected361 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected358 at risk EG0010 affected361 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0013 affected361 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected358 at risk EG0010 affected361 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected358 at risk EG0010 affected361 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0011 affected361 at risk
Bone fissure	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Myocardial infarction	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0005 affected358 at risk EG0011 affected361 at risk
Angina pectoris	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0015 affected361 at risk
Myocardial Ischaemia	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected358 at risk EG0011 affected361 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected358 at risk EG0010 affected361 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0011 affected361 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Arrhythmia	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Atrial flutter	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Bradycardia	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Cardiac arrest	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Cardiac fibrillation	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Coronary artery disease	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected358 at risk EG0011 affected361 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0011 affected361 at risk
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Brain neoplasm benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Gastrointestinal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Haemangioma of liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Laryngeal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Medullary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Metastatic gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Metastatic renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Multiple myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Peritoneal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Rectal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Signet-ring cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0004 affected358 at risk EG0015 affected361 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected358 at risk EG0010 affected361 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0012 affected361 at risk
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Pneumonia	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0012 affected361 at risk
Diverticulitis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0011 affected361 at risk
Appendicitis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Bronchitis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Cystitis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Infected skin ulcer	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Pyelonephritis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Sinusitis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Tetanus	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Ureteritis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Wound infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Aortic aneurysm	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0011 affected361 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected358 at risk EG0010 affected361 at risk
Hypertension	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0011 affected361 at risk
Varicose vein	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0012 affected361 at risk
Intermittent claudication	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Temporal arteritis	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Thrombophlebitis	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Cataract	Eye disorders	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected358 at risk EG0012 affected361 at risk
Keratoconus	Eye disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Entropion	Eye disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Retinal detachment	Eye disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected358 at risk EG0010 affected361 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Gastritis	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Hernial eventration	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Melaena	Gastrointestinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Cystocele	Reproductive system and breast disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0013 affected361 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0011 affected361 at risk
Cervix disorder	Reproductive system and breast disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Genital prolapse	Reproductive system and breast disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Rectocele	Reproductive system and breast disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Vaginal disorder	Reproductive system and breast disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected358 at risk EG0010 affected361 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Facial paresis	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Hemiparesis	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0012 affected361 at risk
Bladder prolapse	Renal and urinary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0011 affected361 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Pulmonary sarcoidosis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Cachexia	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Central obesity	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Chest pain	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
General physical health deterioration	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Oedema peripheral	General disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0002 affected358 at risk EG0010 affected361 at risk
Biliary tract disorder	Hepatobiliary disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Sudden hearing loss	Ear and labyrinth disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk
Goitre	Endocrine disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Hyperthyroidism	Endocrine disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Fibrous dysplasia of bone	Congenital, familial and genetic disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Weight decreased	Investigations	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Confusional state	Psychiatric disorders	MedDRA (10.1)	Non-systematic Assessment	EG0001 affected358 at risk EG0010 affected361 at risk
Diabetes mellitus management	Surgical and medical procedures	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected358 at risk EG0011 affected361 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG00046 affected358 at risk EG00140 affected361 at risk
Urinary tract infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG00022 affected358 at risk EG00127 affected361 at risk
Bronchitis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG00024 affected358 at risk EG00121 affected361 at risk
Influenza	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG00022 affected358 at risk EG00115 affected361 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG00032 affected358 at risk EG00131 affected361 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG00032 affected358 at risk EG00136 affected361 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG00019 affected358 at risk EG00124 affected361 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG00018 affected358 at risk EG00115 affected361 at risk
Hypertension	Vascular disorders	MedDRA (10.1)	Non-systematic Assessment	EG00042 affected358 at risk EG00149 affected361 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG00030 affected358 at risk EG00123 affected361 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	Ibandronate 100 mg	100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
BG001	Ibandronate 150 mg	150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
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	Ibandronate 100 mg	100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)			68	358	187	358
EG001	Ibandronate 150 mg	150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)			70	361	185	361