A Study of Monthly Risedronate for Osteoporosis | NCT00247273

ID	Type	Description	Link
EFC6062 AND HMRF004M/3001

Name	Class
Sanofi	INDUSTRY

Label	Type	Description	Intervention Names
1	Active Comparator	5 mg risedronate, once daily for 2 years	Drug: risedronate
2	Experimental	150 mg risedronate taken once a month for 2 years	Drug: risedronate

Name	Type	Description	Arm Group Labels	Other Names
risedronate	Drug	tablet, 5 mg risedronate, once a day for 2 years	1

Measure	Description	Time Frame
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12-Endpoint in Women With Postmenopausal Osteoporosis, Primary Efficacy Population	BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 12).	Baseline to Month 12 - Endpoint

Measure	Description	Time Frame
Percent Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population	BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.	Baseline to Month 12
Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population

Name	Affiliation	Role
Sal Bartelmo, MD	P&G	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Lakewood	Colorado	80227	United States
Research Site

ID	Title	Description
FG000	5 mg Risedronate	5 mg risedronate tablet, once daily for 2 years
FG001	150 mg Risedronate	150 mg risedronate taken once a month for 2 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

Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12-Endpoint in Women With Postmenopausal Osteoporosis, Primary Efficacy Population

BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 12).

ITT (intent to treat) Population

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to Month 12 - Endpoint

ID	Title	Description
OG000	5 mg Risedronate	5 mg risedronate tablet, once daily for 2 years
OG001	150 mg Risedronate	150 mg risedronate taken once a month for 2 years

Units	Counts
Participants	OG000642 OG001650

Title

Denominators

Categories

Title	Measurements
	OG0003.425(3.028 to 3.823) OG0013.540(3.147 to 3.934)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANOVA	Fixed effects for treatment and pooled center			Least Square (LS) Mean Difference	-0.115			2-Sided	95	-0.505	0.274				Yes	Non-Inferiority or Equivalence	In order to establish noninferiority for the primary efficacy variable at one-sided α of 2.5% with 90% power, a total of 1068 patients, 534 per treatment group, is required. This calculation is based on the following assumptions: the noninferiority margin (or delta) = 1.5%, the common SD (standard deviation) of the percent change from baseline in lumbar spine BMD at Month 12 = 4.5%, the 1 year dropout rate = 20%, and the true mean difference μD - μM = 0.5%.

Secondary

Percent Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population

BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.

ITT Population

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to Month 12

ID	Title	Description
OG000	5 mg Risedronate	5 mg risedronate tablet, once daily for 2 years
OG001	150 mg Risedronate	150 mg risedronate taken once a month for 2 years

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population

BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.

ITT

Posted

Least Squares Mean

95% Confidence Interval

g/cm^2

Baseline to Month 12

ID	Title	Description
OG000	5 mg Risedronate	5 mg risedronate tablet, once daily for 2 years
OG001	150 mg Risedronate	150 mg risedronate taken once a month for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Lumbar Spine BMD at Month 24-Endpoint, Endpoint Population (Month 24)

BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 24).

ITT Population

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to Month 24 - Endpoint

ID	Title	Description
OG000	5 mg Risedronate	5 mg risedronate tablet, once daily for 2 years
OG001	150 mg Risedronate	150 mg risedronate taken once a month for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population

BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.

ITT

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to Month 24

ID	Title	Description
OG000	5 mg Risedronate	5 mg risedronate tablet, once daily for 2 years
OG001	150 mg Risedronate	150 mg risedronate taken once a month for 2 years

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population

BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.

ITT

Posted

Least Squares Mean

95% Confidence Interval

g/cm^2

Baseline to Month 24

ID	Title	Description
OG000	5 mg Risedronate	5 mg risedronate tablet, once daily for 2 years
OG001	150 mg Risedronate	150 mg risedronate taken once a month for 2 years

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Urine Type-1 Collagen Cross-linked-N-telopeptide Corrected for Creatinine Clearance (NTX/Cr) at Month 6, ITT Population

Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24. nmol BCE / mmol Creatinine = nanomoles bone collagen equivalents / millimoles Creatinine

ITT

Posted

Least Squares Mean

95% Confidence Interval

nmol BCE / mmol Creatinine

Baseline to Month 6

ID	Title	Description
OG000	5 mg Risedronate	5 mg risedronate tablet, once daily for 2 years
OG001	150 mg Risedronate	150 mg risedronate taken once a month for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Urine NTX/Cr at Month 6, ITT Population

ITT

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to Month 6

ID	Title	Description
OG000	5 mg Risedronate	5 mg risedronate tablet, once daily for 2 years
OG001	150 mg Risedronate	150 mg risedronate taken once a month for 2 years

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Urine NTX/Cr at Month 24, ITT Population

ITT

Posted

Least Squares Mean

95% Confidence Interval

nmol BCE / mmol Creatinine

Baseline to Month 24

ID	Title	Description
OG000	5 mg Risedronate	5 mg risedronate tablet, once daily for 2 years
OG001	150 mg Risedronate	150 mg risedronate taken once a month for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Urine NTX/Cr at Month 24, ITT Population

ITT

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to Month 24

ID	Title	Description
OG000	5 mg Risedronate	5 mg risedronate tablet, once daily for 2 years
OG001	150 mg Risedronate	150 mg risedronate taken once a month for 2 years

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Serum Type-1 Collagen Cross-linked C-telopeptide (CTX) at Month 6, ITT Population

ng / mL = nanograms / milliliter. Assayed by electrochemiluminescent immunoassay.

ITT

Posted

Least Squares Mean

95% Confidence Interval

ng / mL

Baseline to Month 6

ID	Title	Description
OG000	5 mg Risedronate	5 mg risedronate tablet, once daily for 2 years
OG001	150 mg Risedronate	150 mg risedronate taken once a month for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Serum CTX at Month 6, ITT Population

Assayed by electrochemiluminescent immunoassay.

ITT

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to Month 6

ID	Title	Description
OG000	5 mg Risedronate	5 mg risedronate tablet, once daily for 2 years
OG001	150 mg Risedronate	150 mg risedronate taken once a month for 2 years

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Serum CTX at Month 24, ITT Population

Assayed by electrochemiluminescent immunoassay.

ITT

Posted

Least Squares Mean

95% Confidence Interval

ng / mL

Baseline to Month 24

ID	Title	Description
OG000	5 mg Risedronate	5 mg risedronate tablet, once daily for 2 years
OG001	150 mg Risedronate	150 mg risedronate taken once a month for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Serum CTX at Month 24, ITT Population

Assayed by electrochemiluminescent immunoassay.

ITT

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to Month 24

ID	Title	Description
OG000	5 mg Risedronate	5 mg risedronate tablet, once daily for 2 years
OG001	150 mg Risedronate	150 mg risedronate taken once a month for 2 years

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Serum Bone-specific Alkaline Phosphatase (BAP) at Month 6, ITT Population

ug / L = micrograms per liter, Assayed by ELISA (enzyme-linked immunosorbent assay)

ITT

Posted

Least Squares Mean

95% Confidence Interval

ug / L

Baseline to Month 6

ID	Title	Description
OG000	5 mg Risedronate	5 mg risedronate tablet, once daily for 2 years
OG001	150 mg Risedronate	150 mg risedronate taken once a month for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Serum BAP at Month 6, ITT Population

Assayed by ELISA (enzyme-linked immunosorbent assay)

ITT

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to Month 6

ID	Title	Description
OG000	5 mg Risedronate	5 mg risedronate tablet, once daily for 2 years
OG001	150 mg Risedronate	150 mg risedronate taken once a month for 2 years

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Serum BAP at Month 24, ITT Population

Assayed by ELISA (enzyme-linked immunosorbent assay)

ITT

Posted

Least Squares Mean

95% Confidence Interval

ug / L

Baseline to Month 24

ID	Title	Description
OG000	5 mg Risedronate	5 mg risedronate tablet, once daily for 2 years
OG001	150 mg Risedronate	150 mg risedronate taken once a month for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Serum BAP at Month 24, ITT Population

Assayed by ELISA (enzyme-linked immunosorbent assay)

ITT

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to Month 24

ID	Title	Description
OG000	5 mg Risedronate	5 mg risedronate tablet, once daily for 2 years
OG001	150 mg Risedronate	150 mg risedronate taken once a month for 2 years

Units	Counts
Participants	OG000

Secondary

Number of Participants With New Vertebral Fracture at Month 12, ITT Population

At least 1 new fractured vertebra

ITT

Posted

Number

Participants

Baseline to Month 12

ID	Title	Description
OG000	5 mg Risedronate	5 mg risedronate tablet, once daily for 2 years
OG001	150 mg Risedronate	150 mg risedronate taken once a month for 2 years

Units	Counts
Participants	OG000

Secondary

Number of Participants With New Vertebral Fracture at Month 24, ITT Population

At least 1 new fractured vertebra

ITT

Posted

Number

Participants

Baseline to Month 24

ID	Title	Description
OG000	5 mg Risedronate	5 mg risedronate tablet, once daily for 2 years
OG001	150 mg Risedronate	150 mg risedronate taken once a month for 2 years

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Myocardial Ischaemia	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0013 events3 affected650 at risk
Acute Coronary Syndrome	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0013 events2 affected650 at risk
Angina Unstable	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0012 events2 affected650 at risk
Angina Pectoris	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0011 events1 affected650 at risk
Myocardial Infarction	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0011 events1 affected650 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0014 events3 affected650 at risk
Congestive Cardiomyopathy	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0011 events1 affected650 at risk
Hypertrophic Cardiomyopathy	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0011 events1 affected650 at risk
Aortic Valve Incompetence	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events1 affected642 at risk EG0010 events0 affected650 at risk
Cardiac Failure	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Cardiac Arrest	Cardiac disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected642 at risk EG0013 events3 affected650 at risk
Ischaemic Stroke	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Carotid Artery Stenosis	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Vertebrobasilar Insufficiency	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Loss of Consciousness	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Syncope	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Transient Ischaemic Attack	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0012 events2 affected650 at risk
Dementia Alzheimer's Type	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Facial Palsy	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Sciatica	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Lumbar Radiculopathy	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Cubital Tunnel Syndrome	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Epilepsy	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Presyncope	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Parkinson's Disease	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0003 events3 affected642 at risk EG0017 events7 affected650 at risk
Benign Neoplasm of Thyroid Gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Thyroid Adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Fibroadenoma of Breast	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Cerebellar Tumor	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Lung Adenocarcinoma Stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Lung Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Colon Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Colorectal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Parathyroid Tumour Benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Acute Myeloid Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Metastases to Lymph Nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Renal Cell Carcinoma Stage Unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected642 at risk EG0010 events0 affected650 at risk
Bronchopneumonia	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0012 events2 affected650 at risk
Pneumonia	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0006 events5 affected642 at risk EG0012 events2 affected650 at risk
Bronchitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected642 at risk EG0010 events0 affected650 at risk
Urinary Tract Infection	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0012 events2 affected650 at risk
Pyelonephritis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Postoperative Abscess	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Diverticulitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Gastroenteritis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Toxoplasmosis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Chronic Sinusitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0012 events1 affected650 at risk
Pharyngolaryngeal abscess	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Filariasis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Staphylococcal Sepsis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Erysipelas	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Lymphangitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Patella Fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0012 events2 affected650 at risk
Femur Fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Fibula Fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Tibia Fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Hip Fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected642 at risk EG0010 events0 affected650 at risk
Hand Fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Humerus Fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Radius Fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Wrist Fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0011 events1 affected650 at risk
Road Traffic Accident	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Head Injury	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Spinal Compression Fracture	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Pancreatitis Acute	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0012 events2 affected650 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events1 affected642 at risk EG0011 events1 affected650 at risk
Erosive Duodenitis	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Gastritis	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Adbominal Pain Upper	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Intestinal Prolapse	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Gastritis Erosive	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Subileus	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Large Intestine Perforation	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Lower Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Umbilical Hernia	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Cholelithiasis	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0002 events2 affected642 at risk EG0014 events4 affected650 at risk
Hepatic Cyst	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Cholangitis	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Bile Duct Stone	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Eosinophilic Fasciitis	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Chondrocalcinosis	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Foot Deformity	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Rheumatoid Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Vaginal Prolapse	Reproductive system and breast disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0012 events2 affected650 at risk
Colpocele	Reproductive system and breast disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Rectocele	Reproductive system and breast disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0011 events1 affected650 at risk
Cystocele	Reproductive system and breast disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Cervical Dysplasia	Reproductive system and breast disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0013 events3 affected650 at risk
Asthmatic Crisis	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0011 events1 affected650 at risk
Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Lung Disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Hypertensive Emergency	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Aortic Dilatation	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Varicose Vein	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0011 events1 affected650 at risk
Cardiovascular Insufficiency	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Bladder Prolapse	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Urethral Stenosis	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Haematuria	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Calculus Urinary	Renal and urinary disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Febrile Neutropenia	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0012 events1 affected650 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0012 events1 affected650 at risk
Chest Pain	General disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Death	General disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Major Depression	Psychiatric disorders	MedDRA (11.0)	Systematic Assessment	EG0000 events0 affected642 at risk EG0011 events1 affected650 at risk
Blindness	Eye disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Cataract	Eye disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Drug Hypersensitivity	Immune system disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Pemphigoid	Skin and subcutaneous tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk
Drug Eruption	Skin and subcutaneous tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0001 events1 affected642 at risk EG0010 events0 affected650 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Influenza	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG00062 events57 affected642 at risk EG001112 events94 affected650 at risk
Nasopharyngitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG00076 events62 affected642 at risk EG00186 events70 affected650 at risk
Urinary Tract Infection	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG00058 events50 affected642 at risk EG00183 events61 affected650 at risk
Bronchitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG00076 events68 affected642 at risk EG00174 events57 affected650 at risk
Diarrrhoea	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG00049 events43 affected642 at risk EG00195 events69 affected650 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG00065 events51 affected642 at risk EG00174 events62 affected650 at risk
Nausea	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG00061 events52 affected642 at risk EG00156 events47 affected650 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG00041 events37 affected642 at risk EG00152 events44 affected650 at risk
Constipation	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG00056 events53 affected642 at risk EG00152 events43 affected650 at risk
Vomiting	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG00036 events32 affected642 at risk EG00141 events36 affected650 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG00081 events68 affected642 at risk EG00176 events65 affected650 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG00087 events80 affected642 at risk EG00173 events65 affected650 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG00037 events35 affected642 at risk EG00150 events45 affected650 at risk
Headache	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG00051 events38 affected642 at risk EG00137 events35 affected650 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG00057 events45 affected642 at risk EG00166 events57 affected650 at risk
Hypertension	Vascular disorders	MedDRA (11.0)	Systematic Assessment	EG00053 events49 affected642 at risk EG00155 events52 affected650 at risk
Gastroenteritis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG00024 events21 affected642 at risk EG00125 events24 affected650 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG00012 events11 affected642 at risk EG00124 events18 affected650 at risk
Pneumonia	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG00010 events7 affected642 at risk EG00113 events13 affected650 at risk
Tooth Infection	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG00014 events13 affected642 at risk EG00116 events11 affected650 at risk
Cystitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG00022 events19 affected642 at risk EG00111 events10 affected650 at risk
Sinusitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG00015 events15 affected642 at risk EG00110 events10 affected650 at risk
Pharyngitis	Infections and infestations	MedDRA (11.0)	Systematic Assessment	EG00015 events14 affected642 at risk EG00110 events9 affected650 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG00036 events32 affected642 at risk EG00148 events31 affected650 at risk
Gastritis	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG00021 events19 affected642 at risk EG00126 events24 affected650 at risk
Abdominal Distention	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG00018 events16 affected642 at risk EG00124 events19 affected650 at risk
Flatulence	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG00019 events19 affected642 at risk EG00121 events18 affected650 at risk
Hyperchlorhydria	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG0004 events4 affected642 at risk EG00118 events18 affected650 at risk
Gastroesophageal Reflux Disease	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG00014 events13 affected642 at risk EG00111 events11 affected650 at risk
Hiatus Hernia	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG00020 events20 affected642 at risk EG0018 events8 affected650 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG00015 events14 affected642 at risk EG0017 events7 affected650 at risk
Dry Mouth	Gastrointestinal disorders	MedDRA (11.0)	Systematic Assessment	EG00013 events13 affected642 at risk EG0013 events3 affected650 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG00028 events24 affected642 at risk EG00131 events29 affected650 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG00015 events14 affected642 at risk EG00123 events22 affected650 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG00021 events20 affected642 at risk EG00122 events20 affected650 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG00013 events12 affected642 at risk EG00119 events17 affected650 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG00017 events16 affected642 at risk EG00116 events16 affected650 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG00020 events19 affected642 at risk EG00115 events15 affected650 at risk
Muscle Contracture	Musculoskeletal and connective tissue disorders	MedDRA (11.0)	Systematic Assessment	EG00014 events14 affected642 at risk EG0016 events6 affected650 at risk
Dizziness	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG00020 events17 affected642 at risk EG00127 events26 affected650 at risk
Sciatica	Nervous system disorders	MedDRA (11.0)	Systematic Assessment	EG00012 events11 affected642 at risk EG00119 events17 affected650 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (11.0)	Systematic Assessment	EG00026 events19 affected642 at risk EG00124 events17 affected650 at risk
Asthenia	General disorders	MedDRA (11.0)	Systematic Assessment	EG00019 events18 affected642 at risk EG00124 events23 affected650 at risk
Chest Pain	General disorders	MedDRA (11.0)	Systematic Assessment	EG00011 events11 affected642 at risk EG00121 events21 affected650 at risk
Oedema Peripheral	General disorders	MedDRA (11.0)	Systematic Assessment	EG00011 events10 affected642 at risk EG00114 events14 affected650 at risk
Pyrexia	General disorders	MedDRA (11.0)	Systematic Assessment	EG0009 events8 affected642 at risk EG00125 events13 affected650 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (11.0)	Systematic Assessment	EG00022 events20 affected642 at risk EG00125 events24 affected650 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (11.0)	Systematic Assessment	EG0007 events7 affected642 at risk EG00116 events14 affected650 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (11.0)	Systematic Assessment	EG00022 events19 affected642 at risk EG00114 events10 affected650 at risk
Depression	Psychiatric disorders	MedDRA (11.0)	Systematic Assessment	EG00019 events19 affected642 at risk EG00121 events20 affected650 at risk
Anxiety	Psychiatric disorders	MedDRA (11.0)	Systematic Assessment	EG00013 events13 affected642 at risk EG00118 events18 affected650 at risk
Insomnia	Psychiatric disorders	MedDRA (11.0)	Systematic Assessment	EG00016 events16 affected642 at risk EG0019 events9 affected650 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA (11.0)	Systematic Assessment	EG00012 events12 affected642 at risk EG00122 events22 affected650 at risk
Cataract	Eye disorders	MedDRA (11.0)	Systematic Assessment	EG00013 events12 affected642 at risk EG00119 events16 affected650 at risk
Conjunctivitis	Eye disorders	MedDRA (11.0)	Systematic Assessment	EG0006 events6 affected642 at risk EG00113 events13 affected650 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (11.0)	Systematic Assessment	EG00011 events9 affected642 at risk EG00119 events17 affected650 at risk

ID	Term
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
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	5 mg Risedronate	5 mg risedronate tablet, once daily for 2 years
BG001	150 mg Risedronate	150 mg risedronate taken once a month for 2 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	5 mg Risedronate	5 mg risedronate tablet, once daily for 2 years			51	642	554	642
EG001	150 mg Risedronate	150 mg risedronate taken once a month for 2 years			77	650	578	650