Assess the Safety, Efficacy, and Pharmacokinetics of Imme... | NCT00577720

NCT00577720

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
35 mg IRBB	Active Comparator	35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks	Drug: risedronate
35 mg DRFB	Experimental	35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks	Drug: risedronate
50 mg DRFB	Experimental	50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks	Drug: risedronate
50 mg DRBB	Experimental	50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks	Drug: risedronate

Name	Type	Description	Arm Group Labels	Other Names
risedronate	Drug	35mg immediate release risedronate tablet before breakfast, once a week for 13 weeks	35 mg IRBB

Outcomes Module

Measure	Description	Time Frame
Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population		Baseline and Week 13

Secondary Outcomes

Measure	Description	Time Frame
Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population		Baseline and Week 13
Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population		Baseline and Week 13

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Lu A Sun, MD, PhD	Procter and Gamble	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Facility		Costa Mesa	California	92626	United States
Research Facility

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	35 mg IRBB (Immediate Release Before Breakfast)	35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
FG001	35 mg DRFB (Delayed Release Following Breakfast)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	35 mg IRBB (Immediate Release Before Breakfast)	35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
BG001	35 mg DRFB (Delayed Release Following Breakfast)	35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
BG002	50 mg DRFB	50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
BG003	50 mg DRBB (Delayed Release Before Breakfast)	50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00037 BG00136 BG00236 BG00372 BG004181

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00061.1± 6.2 BG00158.9± 6.7 BG00260.0± 6.1 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00037 BG00136 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00013 BG0019 BG002

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

Asian (Oriental)

Title	Measurements
	BG0006 BG0016 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00037 BG00136 BG002

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 in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population

ITT Population

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline and Week 13

ID	Title	Description
OG000	35 mg IRBB (Immediate Release Before Breakfast)	35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
OG001	35 mg DRFB (Delayed Release Following Breakfast)	35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
OG002	50 mg DRFB	50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
OG003	50 mg DRBB (Delayed Release Before Breakfast)	50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks

Units	Counts
Participants	OG00034 OG00135 OG00235 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-43.20(-55.83 to -30.58) OG001-62.08(-73.59 to -50.56) OG002-65.11(-77.70 to -52.52) OG003

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	For power calculations, assumed that variability in test treatment groups is no more than 50% higher than reference group. If true ratio of CTX is 0.65, the power to detect this departure from a ratio of 1.0 in the primary analysis is 0.88.					Ratio (LS Mean 35 mg DRFB/35 mg IRBB)	1.437			2-Sided	90	1.091	1.964				No	Superiority or Other
OG000

Secondary

Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population

ITT Population

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline and Week 13

ID	Title	Description
OG000	35 mg IRBB (Immediate Release Before Breakfast)	35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
OG001	35 mg DRFB (Delayed Release Following Breakfast)	35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
OG002	50 mg DRFB	50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
OG003	50 mg DRBB (Delayed Release Before Breakfast)	50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks

Secondary

Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population

ITT Population

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline and Week 13

ID	Title	Description
OG000	35 mg IRBB (Immediate Release Before Breakfast)	35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
OG001	35 mg DRFB (Delayed Release Following Breakfast)	35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
OG002	50 mg DRFB	50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
OG003	50 mg DRBB (Delayed Release Before Breakfast)	50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	35 mg IRBB (Immediate Release Before Breakfast)	35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks	0	37	27	37
EG001	35 mg DRFB (Delayed Release Following Breakfast)	35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks	1	36	19	36
EG002	50 mg DRFB	50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks	0	36	24	36
EG003	50 mg DRBB (Delayed Release Before Breakfast)	50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks	1	72	51	72

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Appendicitis	Infections and infestations	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0011 events1 affected36 at risk EG0020 events0 affected36 at risk EG0030 events0 affected72 at risk
Chest Pain	General disorders	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (9.0)	Systematic Assessment	EG0003 events3 affected37 at risk EG0014 events4 affected36 at risk EG0020 events0 affected36 at risk EG0033 events3 affected72 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA (9.0)	Systematic Assessment	EG0002 events2 affected37 at risk EG0012 events2 affected36 at risk EG0021 events1 affected36 at risk EG003
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0012 events2 affected36 at risk EG0021 events1 affected36 at risk EG003
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA (9.0)	Systematic Assessment	EG0001 events1 affected37 at risk EG0011 events1 affected36 at risk EG0021 events1 affected36 at risk EG003
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Musculoskeletal Stiffness	Musculoskeletal and connective tissue disorders	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0021 events1 affected36 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (9.0)	Systematic Assessment	EG0001 events1 affected37 at risk EG0012 events2 affected36 at risk EG0021 events1 affected36 at risk EG003
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA (9.0)	Systematic Assessment	EG0002 events1 affected37 at risk EG0012 events2 affected36 at risk EG0021 events1 affected36 at risk EG003
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA (9.0)	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Pain in Jaw	Musculoskeletal and connective tissue disorders	MedDRA (9.0)	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0022 events2 affected36 at risk EG003
Groin Pain	Musculoskeletal and connective tissue disorders	MedDRA (9.0)	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0013 events3 affected36 at risk EG0021 events1 affected36 at risk EG003
Abdominal Pain	Gastrointestinal disorders	MedDRA (9.0)	Systematic Assessment	EG0001 events1 affected37 at risk EG0012 events2 affected36 at risk EG0024 events2 affected36 at risk EG003
Abdominal Tenderness	Gastrointestinal disorders	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0021 events1 affected36 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (9.0)	Systematic Assessment	EG0004 events4 affected37 at risk EG0013 events2 affected36 at risk EG0020 events0 affected36 at risk EG003
Eructation	Gastrointestinal disorders	MedDRA (9.0)	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (9.0)	Systematic Assessment	EG0003 events3 affected37 at risk EG0012 events2 affected36 at risk EG0024 events4 affected36 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (9.0)	Systematic Assessment	EG0002 events2 affected37 at risk EG0011 events1 affected36 at risk EG0023 events3 affected36 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA (9.0)	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (9.0)	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected36 at risk EG0026 events6 affected36 at risk EG003
Abdominal Distension	Gastrointestinal disorders	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0021 events1 affected36 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA (9.0)	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (9.0)	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected36 at risk EG0022 events2 affected36 at risk EG003
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Stomach Discomfort	Gastrointestinal disorders	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0021 events1 affected36 at risk EG003
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Headache	Nervous system disorders	MedDRA (9.0)	Systematic Assessment	EG0009 events7 affected37 at risk EG00111 events8 affected36 at risk EG00210 events10 affected36 at risk EG003
Sinus Headache	Nervous system disorders	MedDRA (9.0)	Systematic Assessment	EG0001 events1 affected37 at risk EG0012 events1 affected36 at risk EG0021 events1 affected36 at risk EG003
Somnolence	Nervous system disorders	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Dizziness	Nervous system disorders	MedDRA (9.0)	Systematic Assessment	EG0002 events2 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA (9.0)	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Herpes Zoster	Infections and infestations	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0011 events1 affected36 at risk EG0020 events0 affected36 at risk EG003
Herpes Simplex	Infections and infestations	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (9.0)	Systematic Assessment	EG0001 events1 affected37 at risk EG0011 events1 affected36 at risk EG0020 events0 affected36 at risk EG003
Sinusitis	Infections and infestations	MedDRA (9.0)	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	MedDRA (9.0)	Systematic Assessment	EG0003 events3 affected37 at risk EG0010 events0 affected36 at risk EG0021 events1 affected36 at risk EG003
Gingival Abscess	Infections and infestations	MedDRA (9.0)	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Fungal Skin Infection	Infections and infestations	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Bronchitis	Infections and infestations	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0021 events1 affected36 at risk EG003
Viral Infection	Infections and infestations	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0021 events1 affected36 at risk EG003
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0011 events1 affected36 at risk EG0021 events1 affected36 at risk EG003
Rhinitis Allergic	Respiratory, thoracic and mediastinal disorders	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0011 events1 affected36 at risk EG0020 events0 affected36 at risk EG003
Sinus Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0011 events1 affected36 at risk EG0021 events1 affected36 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Pharyngolaryngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA (9.0)	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected36 at risk EG0021 events1 affected36 at risk EG003
Postnasal Drip	Respiratory, thoracic and mediastinal disorders	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (9.0)	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0011 events1 affected36 at risk EG0020 events0 affected36 at risk EG003
Abnormal Dreams	Psychiatric disorders	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Ventricular Extrasystoles	Cardiac disorders	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0021 events1 affected36 at risk EG003
Ear Pain	Ear and labyrinth disorders	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0021 events1 affected36 at risk EG003
Conjunctival Haemorrhage	Eye disorders	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Asthenia	General disorders	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Fatigue	General disorders	MedDRA (9.0)	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Pain	General disorders	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Arthropod Bite	Injury, poisoning and procedural complications	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0021 events1 affected36 at risk EG003
Arthropod Sting	Injury, poisoning and procedural complications	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0021 events1 affected36 at risk EG003
Soft Tissue Injury	Injury, poisoning and procedural complications	MedDRA (9.0)	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Skin Laceration	Injury, poisoning and procedural complications	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Blood Glucose Increased	Investigations	MedDRA (9.0)	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Blood Cholesterol Increased	Investigations	MedDRA (9.0)	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Alanine Aminotransferase Increased	Investigations	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0021 events1 affected36 at risk EG003
Aspartate Aminotransferase Increased	Investigations	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0021 events1 affected36 at risk EG003
Blood Sodium Decreased	Investigations	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0021 events1 affected36 at risk EG003
Blood Triglycerides Increased	Investigations	MedDRA (9.0)	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Anorexia	Metabolism and nutrition disorders	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA (9.0)	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (9.0)	Systematic Assessment	EG0001 events1 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003
Hypertension	Vascular disorders	MedDRA (9.0)	Systematic Assessment	EG0000 events0 affected37 at risk EG0010 events0 affected36 at risk EG0020 events0 affected36 at risk EG003

ID	Term
D000068296	Risedronic Acid

Ancestor Terms

ID	Term
D004164	Diphosphonates
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Units	Counts
Participants	OG00034 OG00135 OG00235 OG00365