Efficacy and Safety of Risedronate Therapy Administered 3... | NCT00619957

Name	Class
Sanofi	INDUSTRY

Label	Type	Description	Intervention Names
1	Placebo Comparator	Placebo tablet once a week for 2 years followed by once a week Risedronate for 2 years	Drug: Placebo tablet
Risedronate	Experimental	35 mg risedronate tablet once a week for 2 years followed by open label 35 mg risedronate once a week for 2 years	Drug: Risedronate

Name	Type	Description	Arm Group Labels	Other Names
Placebo tablet	Drug	one placebo once a week for two years followed by one 35 mg risedronate once a week for two years	1

Measure	Description	Time Frame
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), 24 Months/Endpoint, ITT Population.	DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Site will perform at screening to determine if scan should be forwarded to central facility for analysis. Mean of 2 scans performed read by central lab to determine entry qualification. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).	Baseline to 24 Months/Endpoint

Measure	Description	Time Frame
Percent Change From Baseline in Lumbar Spine BMD, Month 6, ITT Population.	DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading.DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).	Baseline to Month 6

Name	Affiliation	Role
Dietrich Wenderoth, MD	Procter and Gamble	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Palm Desert	California	92260	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
22750403	Derived	Boonen S, Lorenc RS, Wenderoth D, Stoner KJ, Eusebio R, Orwoll ES. Evidence for safety and efficacy of risedronate in men with osteoporosis over 4 years of treatment: Results from the 2-year, open-label, extension study of a 2-year, randomized, double-blind, placebo-controlled study. Bone. 2012 Sep;51(3):383-8. doi: 10.1016/j.bone.2012.06.016. Epub 2012 Jun 30.

ID	Title	Description
FG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
FG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week 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), 24 Months/Endpoint, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Site will perform at screening to determine if scan should be forwarded to central facility for analysis. Mean of 2 scans performed read by central lab to determine entry qualification. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).

ITT Population, LOCF (Last Observation Carried Forward)

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to 24 Months/Endpoint

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG00087 OG001188

Title

Denominators

Categories

Title	Measurements
	OG0001.22(0.23 to 2.21) OG0015.75(5.00 to 6.50)

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	A total of 210 patients will be randomized to 35 mg once a week risedronate and placebo groups in 2:1 ratio. Sample size will allow detection of a difference of at least 3% in lumbar spine BMD percent change from Baseline at 24 months between risedronate and placebo with at least 90% power. This calculation is based on the assumptions that the common within-group standard deviation (SD) would be below 5%, and the dropout rate within 2 years is about 35%.	ANOVA	Fixed effects for treatment and pooled center.	<0.0001		Least Square (LS) Mean Difference	4.53			2-Sided	95	3.46	5.60				No	Superiority or Other

Secondary

Percent Change From Baseline in Lumbar Spine BMD, Month 6, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading.DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).

ITT Population

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to Month 6

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

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

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).

ITT Population

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to Month 12

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

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

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Mean of 2 scans performed. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522).

ITT Population

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to Month 24

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Total Proximal Femur BMD, Month 6, ITT Population.

ITT Population

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to Month 6

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Total Proximal Femur BMD, Month 12, ITT Population.

ITT Population

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to Month 12

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Total Proximal Femur BMD, Month 24, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031).

ITT Population

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to Month 24

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Total Proximal Femur BMD, 24 Months/Endpoint, ITT Population.

ITT Population, LOCF (Last Observation Carried Forward)

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to 24 Months/Endpoint

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Femoral Neck BMD, Month 6, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic Reference BMD = (0.836 x BMD[lunar]) - 0.008

ITT Population

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to Month 6

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Femoral Neck BMD, Month 12, ITT Population.

ITT Population

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to Month 12

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Femoral Neck BMD, Month 24, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD[lunar]) - 0.008

ITT Population

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to Month 24

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Femoral Neck BMD, 24 Months/Endpoint, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD[lunar]) - 0.008

ITT Population, LOCF (Last Observation Carried Forward)

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to 24 Months/Endpoint

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Femoral Trochanter BMD, Month 6, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.

ITT Population

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to Month 6

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Femoral Trochanter BMD, Month 12, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.

ITT Population

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to Month 12

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Femoral Trochanter BMD, Month 24, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.

ITT Population

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to Month 24

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in Femoral Trochanter BMD, 24 Months/Endpoint, ITT Population.

DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.

ITT Population, LOCF (Last Observation Carried Forward)

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to 24 Months/Endpoint

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in CTx (Type I Collagen C-telopeptide), Month 3, ITT Population.

ITT Population

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to Month 3

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in CTx, Month 6, ITT Population.

ITT Population

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to Month 6

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in CTx, Month 12, ITT Population.

ITT Population

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to Month 12

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in CTx, Month 24, ITT Population.

ITT Population

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to Month 24

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in CTx, 24 Months/Endpoint, ITT Population.

ITT Population, LOCF (Last Observation Carried Forward)

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to 24 Months/Endpoint

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in NTx/Cr (Type I Collagen N-telopeptide/Creatinine), Month 3, ITT Population.

ITT Population

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to Month 3

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in NTx/Cr, Month 6, ITT Population.

ITT Population

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to Month 6

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in NTx/Cr, Month 12, ITT Population.

ITT Population

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to Month 12

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in NTx/Cr, Month 24, ITT Population.

ITT Population

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to Month 24

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in NTx/Cr, 24 Months/Endpoint, ITT Population.

ITT Population, LOCF (Last Observation Carried Forward)

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to 24 Months/Endpoint

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in BAP (Bone-specific Alkaline Phosphatase), Month 3, ITT Population.

ITT Population

Posted

Least Squares Mean

95% Confidence Interval

percent

Baseline to Month 3

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in BAP, Month 6, ITT Population.

ITT Population

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to Month 6

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in BAP, Month 12, ITT Population.

ITT Population

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to Month 12

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in BAP, Month 24, ITT Population.

ITT Population

Posted

Least Squares Mean

95% Confidence Interval

percent

Baseline to Month 24

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

Percent Change From Baseline in BAP, 24 Months/Endpoint, ITT Population.

ITT Population, LOCF (Last Observation Carried Forward)

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline to 24 Months/Endpoint

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Body Height, Month 12, ITT Population.

ITT Population

Posted

Least Squares Mean

95% Confidence Interval

millimeters

Baseline to Month 12

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Body Height, Month 24, ITT Population.

ITT Population

Posted

Least Squares Mean

95% Confidence Interval

millimeters

Baseline to Month 24

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Body Height, 24 Months/Endpoint, ITT Population.

ITT Population, LOCF (Last Observation Carried Forward)

Posted

Least Squares Mean

95% Confidence Interval

millimeters

Baseline to 24 Months/Endpoint

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

Percent of Responders Lumbar Spine BMD, Month 24, ITT Population

responder = positive change (>0) in lumbar spine BMD from Baseline to Month 24

ITT Population

Posted

Number

Percentage of Participants

Baseline to Month 24

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

Cumulative Incidence of Fractures, 12 Months, ITT Population

Kaplan-Meier Cumulative Incidence, fractures / 100 patients / year

ITT Population

Posted

Number

Fractures / 100 patients / year

Baseline to Month 12

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Secondary

Cumulative Incidence of Fractures, 24 Months, ITT Population

Kaplan-Meier Cumulative Incidence, fractures / 100 patients / 2 years

ITT Population

Posted

Number

Fractures / 100 patients / 2 years

Baseline to Month 24

ID	Title	Description
OG000	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
OG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute Sinusitis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected191 at risk EG0020 events0 affected67 at risk EG0030 events0 affected151 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0020 events0 affected67 at risk EG003
Anal Haemorrhage	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0020 events0 affected67 at risk EG003
Angina Pectoris	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0002 events1 affected93 at risk EG0010 events0 affected191 at risk EG0021 events1 affected67 at risk EG003
Aortic Aneurysm	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected191 at risk EG0020 events0 affected67 at risk EG003
Appendicitis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected93 at risk EG0011 events1 affected191 at risk EG0020 events0 affected67 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected191 at risk EG0020 events0 affected67 at risk EG003
Arteritis	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected191 at risk EG0020 events0 affected67 at risk EG003
Atherosclerosis Obliterans	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected191 at risk EG0020 events0 affected67 at risk EG003
Atrial Fibrillation	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected93 at risk EG0011 events1 affected191 at risk EG0022 events2 affected67 at risk EG003
Atrioventricular Block	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0021 events1 affected67 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0020 events0 affected67 at risk EG003
Bile Duct Stone	Hepatobiliary disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected191 at risk EG0020 events0 affected67 at risk EG003
Bronchioloalveolar Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0020 events0 affected67 at risk EG003
Bronchitis Acute	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected191 at risk EG0020 events0 affected67 at risk EG003
Burns Third Degree	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0021 events1 affected67 at risk EG003
Cataract	Eye disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0021 events1 affected67 at risk EG003
Cerebrovascular Accident	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected191 at risk EG0020 events0 affected67 at risk EG003
Chest Pain	General disorders	MedDRA (9.1)	Systematic Assessment	EG0002 events2 affected93 at risk EG0010 events0 affected191 at risk EG0020 events0 affected67 at risk EG003
Chronic Lymphocytic Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0020 events0 affected67 at risk EG003
Chronic Obstructive Airways Disease Exacerbated	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected191 at risk EG0020 events0 affected67 at risk EG003
Coronary Artery Disease	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected93 at risk EG0012 events2 affected191 at risk EG0020 events0 affected67 at risk EG003
Coronary Artery Stenosis	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected191 at risk EG0020 events0 affected67 at risk EG003
Deep Vein Thrombosis	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected191 at risk EG0020 events0 affected67 at risk EG003
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected191 at risk EG0020 events0 affected67 at risk EG003
Diverticulitis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0020 events0 affected67 at risk EG003
Diverticulum Intestinal	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected191 at risk EG0020 events0 affected67 at risk EG003
Duodenitis	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0020 events0 affected67 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0012 events1 affected191 at risk EG0020 events0 affected67 at risk EG003
Embolism	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected191 at risk EG0020 events0 affected67 at risk EG003
Epilepsy	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0020 events0 affected67 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected191 at risk EG0020 events0 affected67 at risk EG003
Femoral Neck Fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected191 at risk EG0020 events0 affected67 at risk EG003
Femur Fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0020 events0 affected67 at risk EG003
Forearm Fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0020 events0 affected67 at risk EG003
Gastric Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected191 at risk EG0020 events0 affected67 at risk EG003
Gastric Ulcer	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected191 at risk EG0020 events0 affected67 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected191 at risk EG0020 events0 affected67 at risk EG003
Gastritis Atrophic	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected191 at risk EG0020 events0 affected67 at risk EG003
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected191 at risk EG0022 events2 affected67 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected191 at risk EG0020 events0 affected67 at risk EG003
Haemorrhage	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected191 at risk EG0020 events0 affected67 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0020 events0 affected67 at risk EG003
Hiatus Hernia	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected191 at risk EG0020 events0 affected67 at risk EG003
Hypochromic Anaemia	Blood and lymphatic system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected191 at risk EG0020 events0 affected67 at risk EG003
Inguinal Hernia	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0012 events2 affected191 at risk EG0021 events1 affected67 at risk EG003
Intervertebral Disc Compression	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0021 events1 affected67 at risk EG003
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected191 at risk EG0020 events0 affected67 at risk EG003
Iron Deficiency Anaemia	Blood and lymphatic system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected191 at risk EG0020 events0 affected67 at risk EG003
Ischaemic Stroke	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected191 at risk EG0020 events0 affected67 at risk EG003
Localized Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected191 at risk EG0020 events0 affected67 at risk EG003
Lung Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected93 at risk EG0011 events1 affected191 at risk EG0020 events0 affected67 at risk EG003
Malignant Melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0020 events0 affected67 at risk EG003
Mitral Valve Incompetence	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected191 at risk EG0020 events0 affected67 at risk EG003
Myocardial Infarction	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0005 events3 affected93 at risk EG0011 events1 affected191 at risk EG0021 events1 affected67 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0020 events0 affected67 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected191 at risk EG0020 events0 affected67 at risk EG003
Pancreatitis Acute	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected191 at risk EG0020 events0 affected67 at risk EG003
Pancreatitis Chronic	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected191 at risk EG0020 events0 affected67 at risk EG003
Pneumonia	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected191 at risk EG0020 events0 affected67 at risk EG003
Post Laminectomy Syndrome	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0021 events1 affected67 at risk EG003
Post Procedural Haemorrhage	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected191 at risk EG0020 events0 affected67 at risk EG003
Prostate Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected93 at risk EG0012 events2 affected191 at risk EG0020 events0 affected67 at risk EG003
Prostate Examination Abnormal	Investigations	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0020 events0 affected67 at risk EG003
Prostatic Adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0021 events1 affected67 at risk EG003
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0002 events2 affected93 at risk EG0011 events1 affected191 at risk EG0020 events0 affected67 at risk EG003
Renal Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected93 at risk EG0011 events1 affected191 at risk EG0020 events0 affected67 at risk EG003
Retroperitoneal Abscess	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected191 at risk EG0020 events0 affected67 at risk EG003
Road Traffic Accident	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0020 events0 affected67 at risk EG003
Shock	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected191 at risk EG0020 events0 affected67 at risk EG003
Small Cell Lung Cancer, Stage Unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected191 at risk EG0020 events0 affected67 at risk EG003
Spondylolisthesis	Congenital, familial and genetic disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0020 events0 affected67 at risk EG003
Sudden Cardiac Death	General disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0011 events1 affected191 at risk EG0020 events0 affected67 at risk EG003
Tonsillitis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0020 events0 affected67 at risk EG003
Ventricular Arrhythmia	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0020 events0 affected67 at risk EG003
Vitamin B12 Deficiency	Metabolism and nutrition disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected93 at risk EG0010 events0 affected191 at risk EG0020 events0 affected67 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal Pain	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0003 events3 affected93 at risk EG0014 events4 affected191 at risk EG0020 events0 affected67 at risk EG0030 events0 affected151 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0022 events2 affected67 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0022 events2 affected67 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0008 events8 affected93 at risk EG00113 events11 affected191 at risk EG0022 events2 affected67 at risk EG003
Atrial Fibrillation	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0003 events3 affected93 at risk EG0012 events2 affected191 at risk EG0025 events4 affected67 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0002 events2 affected93 at risk EG00114 events13 affected191 at risk EG0023 events3 affected67 at risk EG003
Benign Prostatic Hyperplasia	Reproductive system and breast disorders	MedDRA (9.1)	Systematic Assessment	EG0003 events3 affected93 at risk EG0019 events9 affected191 at risk EG0023 events3 affected67 at risk EG003
Chest Pain	General disorders	MedDRA (9.1)	Systematic Assessment	EG0004 events4 affected93 at risk EG0015 events4 affected191 at risk EG0020 events0 affected67 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0005 events5 affected93 at risk EG00117 events16 affected191 at risk EG0020 events0 affected67 at risk EG003
Coronary Artery Disease	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0022 events2 affected67 at risk EG003
Depression	Psychiatric disorders	MedDRA (9.1)	Systematic Assessment	EG0004 events4 affected93 at risk EG0012 events2 affected191 at risk EG0020 events0 affected67 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0005 events4 affected93 at risk EG0016 events5 affected191 at risk EG0020 events0 affected67 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0022 events2 affected67 at risk EG003
Gastritis Erosive	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0022 events2 affected67 at risk EG003
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0022 events2 affected67 at risk EG003
Haematoma	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0003 events3 affected93 at risk EG0011 events1 affected191 at risk EG0020 events0 affected67 at risk EG003
Headache	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG00110 events10 affected191 at risk EG0020 events0 affected67 at risk EG003
Herpes Zoster	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0022 events2 affected67 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0023 events3 affected67 at risk EG003
Hypertension	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0004 events4 affected93 at risk EG0015 events5 affected191 at risk EG0021 events1 affected67 at risk EG003
Hypoacusis	Ear and labyrinth disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0022 events2 affected67 at risk EG003
Influenza	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0005 events5 affected93 at risk EG00111 events11 affected191 at risk EG0021 events1 affected67 at risk EG003
Inguinal Hernia	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0022 events2 affected67 at risk EG003
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0022 events2 affected67 at risk EG003
Myocardial Infarction	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0005 events3 affected93 at risk EG0011 events1 affected191 at risk EG0020 events0 affected67 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0005 events5 affected93 at risk EG00113 events11 affected191 at risk EG0022 events2 affected67 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 events1 affected93 at risk EG0017 events6 affected191 at risk EG0020 events0 affected67 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0016 events5 affected191 at risk EG0020 events0 affected67 at risk EG003
Oedema Peripheral	General disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0022 events2 affected67 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0022 events2 affected67 at risk EG003
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0004 events3 affected93 at risk EG0019 events9 affected191 at risk EG0020 events0 affected67 at risk EG003
Pharyngitis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0003 events3 affected93 at risk EG0012 events2 affected191 at risk EG0020 events0 affected67 at risk EG003
Pneumonia	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0022 events2 affected67 at risk EG003
Prostate Examination Abnormal	Investigations	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0022 events2 affected67 at risk EG003
Thoracic Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0024 events3 affected67 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0003 events3 affected93 at risk EG0018 events7 affected191 at risk EG0022 events2 affected67 at risk EG003
Urinary Retention	Renal and urinary disorders	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0022 events2 affected67 at risk EG003
Urinary Tract Infection	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 events0 affected93 at risk EG0010 events0 affected191 at risk EG0022 events2 affected67 at risk EG003

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	Placebo	Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
BG001	Risedronate	35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
BG002	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo Year 2	Placebo tablet once weekly Years 1 & 2	15	93	66	93
EG001	Risedronate Year 2	Risedronate 35 mg tablet once weekly Years 1 & 2	29	191	134	191
EG002	Placebo-Risedronate Year 4	Placebo once weekly Years 1 & 2 followed by risedronate 35 mg once weekly Years 3 & 4	8	67	46	67
EG003	Risedronate Year 4	Risedronate 35 mg tablet once weekly Years 1 thru 4	21	151	97	151