Study of the Effect of Once a Week Risedronate on the Mic... | NCT00386360

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Placebo dose	Drug: Placebo comparator
Risedronate	Experimental	35 mg risedronate, orally, once weekly	Drug: risedronate

Name	Type	Description	Arm Group Labels	Other Names
Placebo comparator	Drug	oral weekly for one year	Placebo
risedronate

Measure	Description	Time Frame
Trabecular Bone Volume to Tissue Volume at Distal Radius, Percent Change From Baseline to Month 12		Baseline and Month 12

Measure	Description	Time Frame
Average Bone Density at Distal Radius, Percent Change From Baseline to Month 12		Baseline and Month 12
Compact Bone Density at Distal Radius, Percent Change From Baseline to Month 12		Baseline and Month 12

Name	Affiliation	Role
Gioacchino D'Alo, MD	P&G Pharmaceuticals, Clinical Development Europe	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Facility		Buenos Aires	Buenos Aires	C1012AAR	Argentina
Research Facility

ID	Title	Description
FG000	Placebo	Placebo, 1 tablet weekly on the same day
FG001	Risedronate	35 mg risedronate tablet, orally, once weekly on the same day

ID	Title	Description
BG000	Placebo	Placebo, 1 tablet weekly on the same day
BG001	Risedronate	35 mg risedronate tablet, orally, once weekly on the same day
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00049 BG001112 BG002161

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

Trabecular Bone Volume to Tissue Volume at Distal Radius, Percent Change From Baseline to Month 12

Primary Efficacy Population - all patients in ITT population who had no major protocol violations and had an evaluable distal radius BV/TV (trabecular bone volume to tissue volume) at baseline and Month 12.

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline and Month 12

ID	Title	Description
OG000	Placebo	Placebo, 1 tablet weekly on the same day
OG001	Risedronate	35 mg risedronate tablet, orally, once weekly on the same day

Units	Counts
Participants	OG00049 OG001110

Title

Denominators

Categories

Title	Measurements
	OG000-1.486(-2.577 to -0.396) OG001-1.255(-2.012 to -0.498)

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	In Laib 1998, the mean and SD of the annual loss in distal radius BV/TV were reported to be 3.5% and 6.4%, respectively. Assuming the treatment difference and SD of the percent change in distal radius BV/TV for this study were the same, it required enrolling 52 patients for placebo and 104 for risedronate to ensure 80% power to achieve 0.05 level of significance. Sample size estimation based on 2-sided 2-sample t-test and assumed effective size of 0.54 and dropout rate of 20%.	ANOVA	LS Means are least squares (adjusted) means from ANOVA model with fixed effects for treatment and pooled center.	0.7096		LS Mean Difference	0.231			2-Sided	95	-0.995	1.458				No

Secondary

Average Bone Density at Distal Radius, Percent Change From Baseline to Month 12

Per Protocol (PP) Population - all patients in ITT population who had no major protocol violations.

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline and Month 12

ID	Title	Description
OG000	Placebo	Placebo, 1 tablet weekly on the same day
OG001	Risedronate	35 mg risedronate tablet, orally, once weekly on the same day

Units	Counts
Participants	OG000

Secondary

Compact Bone Density at Distal Radius, Percent Change From Baseline to Month 12

PP - all patients in ITT population who had no major protocol violations.

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline and Month 12

ID	Title	Description
OG000	Placebo	Placebo, 1 tablet weekly on the same day
OG001	Risedronate	35 mg risedronate tablet, orally, once weekly on the same day

Units	Counts
Participants	OG000

Secondary

Trabecular Bone Density at Distal Radius, Percent Change From Baseline to Month 12

PP - all patients in ITT population who had no major protocol violations.

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline and Month 12

ID	Title	Description
OG000	Placebo	Placebo, 1 tablet weekly on the same day
OG001	Risedronate	35 mg risedronate tablet, orally, once weekly on the same day

Units	Counts
Participants	OG000

Secondary

Average Bone Density at Distal Tibia, Percent Change From Baseline to Month 12

PP - all patients in ITT population who had no major protocol violations.

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline and Month 12

ID	Title	Description
OG000	Placebo	Placebo, 1 tablet weekly on the same day
OG001	Risedronate	35 mg risedronate tablet, orally, once weekly on the same day

Units	Counts
Participants	OG000

Secondary

Compact Bone Density at Distal Tibia, Percent Change From Baseline to Month 12

PP - all patients in ITT population who had no major protocol violations.

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline and Month 12

ID	Title	Description
OG000	Placebo	Placebo, 1 tablet weekly on the same day
OG001	Risedronate	35 mg risedronate tablet, orally, once weekly on the same day

Units	Counts
Participants	OG000

Secondary

Trabecular Bone Density at Distal Tibia, Percent Change From Baseline to Month 12

PP - all patients in ITT population who had no major protocol violations.

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline and Month 12

ID	Title	Description
OG000	Placebo	Placebo, 1 tablet weekly on the same day
OG001	Risedronate	35 mg risedronate tablet, orally, once weekly on the same day

Units	Counts
Participants	OG000

Secondary

Lumbar Spine BMD, Percent Change From Baseline to Month 12

PP - all patients in ITT population who had no major protocol violations.

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline and Month 12

ID	Title	Description
OG000	Placebo	Placebo, 1 tablet weekly on the same day
OG001	Risedronate	35 mg risedronate tablet, orally, once weekly on the same day

Units	Counts
Participants	OG000

Secondary

Total Proximal Femur BMD (Bone Mineral Density), Percent Change From Baseline to Month 12

PP - all patients in ITT population who had no major protocol violations.

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline and Month 12

ID	Title	Description
OG000	Placebo	Placebo, 1 tablet weekly on the same day
OG001	Risedronate	35 mg risedronate tablet, orally, once weekly on the same day

Units	Counts
Participants	OG000

Secondary

Femoral Neck BMD, Percent Change From Baseline to Month 12

PP - all patients in ITT population who had no major protocol violations.

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline and Month 12

ID	Title	Description
OG000	Placebo	Placebo, 1 tablet weekly on the same day
OG001	Risedronate	35 mg risedronate tablet, orally, once weekly on the same day

Units	Counts
Participants	OG000

Secondary

Greater Trochanter BMD, Percent Change From Baseline to Month 12

PP - all patients in ITT population who had no major protocol violations.

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline and Month 12

ID	Title	Description
OG000	Placebo	Placebo, 1 tablet weekly on the same day
OG001	Risedronate	35 mg risedronate tablet, orally, once weekly on the same day

Units	Counts
Participants	OG000

Secondary

Type I Collagen C-Telopeptides, Serum, Percent Change From Baseline to Month 12

ELISA / enzyme-linked immunosorbent assay method by central lab

PP - all patients in ITT population who had no major protocol violations.

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline and Month 12

ID	Title	Description
OG000	Placebo	Placebo, 1 tablet weekly on the same day
OG001	Risedronate	35 mg risedronate tablet, orally, once weekly on the same day

Units	Counts
Participants	OG000

Secondary

Procollagen Type 1 N-Propeptide, Percent Change From Baseline to Month 12

Electrochemiluminescence assay method by central lab

PP - all patients in ITT population who had no major protocol violations.

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline and Month 12

ID	Title	Description
OG000	Placebo	Placebo, 1 tablet weekly on the same day
OG001	Risedronate	35 mg risedronate tablet, orally, once weekly on the same day

Units	Counts
Participants	OG000

Secondary

Height, Percent Change From Baseline to Month 12

PP - all patients in ITT population who had no major protocol violations.

Posted

Least Squares Mean

95% Confidence Interval

Percent Change

Baseline and Month 12

ID	Title	Description
OG000	Placebo	Placebo, 1 tablet weekly on the same day
OG001	Risedronate	35 mg risedronate tablet, orally, once weekly on the same day

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Radius Fracture	Injury, poisoning and procedural complications	MedDRA 9.0	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected110 at risk
Skeletal Injury	Injury, poisoning and procedural complications	MedDRA 9.0	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected110 at risk
Gastrointestinal Disorder	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected110 at risk
Appendicitis	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected110 at risk
Cholera	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk
Vestibuar Neuronitis	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk
Cervical Root Pain	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected110 at risk
Depression	Psychiatric disorders	MedDRA 9.0	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected110 at risk
Panic Reaction	Psychiatric disorders	MedDRA 9.0	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected110 at risk
Urinary Bladder Polyp	Renal and urinary disorders	MedDRA 9.0	Systematic Assessment	EG0000 events0 affected49 at risk EG0011 events1 affected110 at risk
Vertigo Positional	Ear and labyrinth disorders	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk
Ovarian Cyst	Reproductive system and breast disorders	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0005 events5 affected49 at risk EG00111 events10 affected110 at risk
Bronchitis	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0003 events3 affected49 at risk EG0017 events7 affected110 at risk
Gastroenteritis	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0002 events2 affected49 at risk EG0014 events4 affected110 at risk
Influenza	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0004 events4 affected49 at risk EG0014 events4 affected110 at risk
Cholera	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk
Tonsillitis	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk
Vestibular Neuronitis	Infections and infestations	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0014 events4 affected110 at risk
Periodontitis	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0000 events0 affected49 at risk EG0014 events4 affected110 at risk
Constipation	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0013 events3 affected110 at risk
Dental Caries	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0000 events0 affected49 at risk EG0013 events3 affected110 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0000 events0 affected49 at risk EG0014 events3 affected110 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0012 events2 affected110 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0002 events2 affected49 at risk EG0012 events1 affected110 at risk
Gastritis	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0002 events2 affected49 at risk EG0012 events1 affected110 at risk
Glossodynia	Gastrointestinal disorders	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG0002 events2 affected49 at risk EG00111 events8 affected110 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG0005 events5 affected49 at risk EG0014 events3 affected110 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0013 events3 affected110 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG0000 events0 affected49 at risk EG0013 events3 affected110 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG0003 events3 affected49 at risk EG0013 events3 affected110 at risk
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG0002 events2 affected49 at risk EG0012 events2 affected110 at risk
Chondropathy	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected110 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG0002 events1 affected49 at risk EG0011 events1 affected110 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 9.0	Systematic Assessment	EG0000 events0 affected49 at risk EG0014 events4 affected110 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 9.0	Systematic Assessment	EG0000 events0 affected49 at risk EG0013 events3 affected110 at risk
Radius Fracture	Injury, poisoning and procedural complications	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected110 at risk
Back Injury	Injury, poisoning and procedural complications	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk
Joint Sprain	Injury, poisoning and procedural complications	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk
Limb Injury	Injury, poisoning and procedural complications	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk
Hypertension	Vascular disorders	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0015 events5 affected110 at risk
Hot Flush	Vascular disorders	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0013 events3 affected110 at risk
Headache	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0002 events2 affected49 at risk EG0013 events3 affected110 at risk
Cervicobrachial Syndrome	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk
Paraesthesia	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0002 events1 affected49 at risk EG0010 events0 affected110 at risk
Drug Intolerance	General disorders	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk
Irritability	General disorders	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk
Oedema Peripheral	General disorders	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk
Sensation of Foreign Body	General disorders	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk
Temperature Intolerance	General disorders	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk
Ovarian Cyst	Reproductive system and breast disorders	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk
Vulvovaginal Dryness	Reproductive system and breast disorders	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk
Onchoclasis	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 9.0	Systematic Assessment	EG0000 events0 affected49 at risk EG0014 events3 affected110 at risk
Weight Decreased	Investigations	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected110 at risk
Weight Increased	Investigations	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0011 events1 affected110 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk
Angina	Cardiac disorders	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk
Tachycardia	Cardiac disorders	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk
Depression	Psychiatric disorders	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0012 events2 affected110 at risk
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk
Ear Pain	Ear and labyrinth disorders	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk
Vertigo Positional	Ear and labyrinth disorders	MedDRA 9.0	Systematic Assessment	EG0001 events1 affected49 at risk EG0010 events0 affected110 at risk

ID	Term
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	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Placebo, 1 tablet weekly on the same day			5	49	38	49
EG001	Risedronate	35 mg risedronate tablet, orally, once weekly on the same day			7	110	76	110