A Study That Will Compare the Effect of Two Drugs on Part... | NCT00887354

ID	Type	Description	Link
B3D-EW-GHDK	Other Identifier	Eli Lilly and Company

Label	Type	Description	Intervention Names
Teriparatide	Experimental	20 micrograms (mcg) a day by subcutaneous injection throughout study. Placebo oral tablets once a week, to match the active comparator weekly dose, during the double-blind, double-dummy phase only.	Drug: Teriparatide Drug: Placebo Dietary Supplement: Calcium Dietary Supplement: Vitamin D
Risedronate	Active Comparator	35 milligrams (mg) risedronate sodium orally once weekly throughout study. Daily placebo injection, to match the daily experimental drug dose, during the double-blind, double-dummy phase only.	Drug: Risedronate Drug: Placebo Dietary Supplement: Calcium Dietary Supplement: Vitamin D

Name	Type	Description	Arm Group Labels	Other Names
Teriparatide	Drug	Administered subcutaneously	Teriparatide	Forteo

Measure	Description	Time Frame
Change in Lumbar Spine Areal Bone Mineral Density (BMD)	Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No).	Baseline, Week 78

Measure	Description	Time Frame
Change in Lumbar Spine Areal Bone Mineral Density	Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No).	Baseline, Week 26; Baseline, Week 52

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM eastern time (UTC/GMT-5hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		Fort Lauderdale	Florida	33316

ID	Title	Description
FG000	Teriparatide	20 microgram (mcg) a day by subcutaneous (SC) injection throughout study. Calcium: Approximately 500 to 1000 milligram per day (mg/day) administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
FG001

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

Change in Lumbar Spine Areal Bone Mineral Density (BMD)

Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No).

All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.

Posted

Least Squares Mean

Standard Error

gram per square centimeter (g/cm^2)

Baseline, Week 78

ID	Title	Description
OG000	Teriparatide	20 mg per day by SC injection throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
OG001	Risedronate	35 mg risedronate sodium orally once weekly throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.

Units	Counts
Participants	OG00061 OG00166

Title

Denominators

Categories

Title	Measurements
	OG0000.094± 0.0075 OG0010.055± 0.0081

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		Mixed Models Analysis		<.0001		LS Mean	0.040			2-Sided	95	0.025	0.055					Superiority or Other (legacy)

Secondary

Change in Lumbar Spine Areal Bone Mineral Density

All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.

Posted

Least Squares Mean

Standard Error

g/cm^2

Baseline, Week 26; Baseline, Week 52

ID	Title	Description
OG000	Teriparatide	20 mcg a day by SC injection throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
OG001	Risedronate	35 mg risedronate sodium orally once weekly throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.

Units	Counts
Participants

Secondary

Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb

Femoral neck BMD: Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline femoral neck BMD and type of hip fracture (31-A1/31-A2) .

Total hip BMD: Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline total hip BMD, type of hip fracture (31-A1/31-A2) and duration of prior bisphosphonate use.

All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.

Posted

Least Squares Mean

Standard Error

g/cm^2

Baseline, Week 26; Baseline, Week 52; Baseline, Week 78

ID	Title	Description
OG000	Teriparatide	20 mcg a day by SC injection throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
OG001	Risedronate	35 mg risedronate sodium orally once weekly throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.

Secondary

Change From Baseline in Physical Component Summary of the Short Form-36 (SF-36) Questionnaire

SF-36 is a self-reported questionnaire consisting of 36 questions covering 8 health domains. Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The physical component summary (PCS) has been constructed based on the 8 SF-36 domains and consist of the physical functioning, bodily pain, role-physical, and general health scales (range = 0 to 100, with higher scores indicating better health status for functioning). Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for type of hip fracture (31-A1/31-A2) and adequate reduction (Yes/No).

All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline, Week 6; Baseline, Week 12; Baseline, Week 18; Baseline, Week 26

ID	Title	Description
OG000	Teriparatide	20 mcg a day by SC injection throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
OG001	Risedronate	35 mg risedronate sodium orally once weekly throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.

Secondary

Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale

Self-reported hip pain scale in which 0=no pain; 1=pain is slight or intermittent, pain on starting to walk but getting less with normal activity; 2=pain occurs only after some activity, disappears quickly with rest; 3=pain is tolerable, permitting limited activity; 4=pain is severe on attempting to walk, prevents all activity; 5=pain is severe and spontaneous.

All randomized participants receiving at least one dose of study drug and having baseline Charnley's Pain Scale data.

Posted

Number

percentage of participants

Baseline

ID	Title	Description
OG000	Teriparatide	20 mg per day by SC injection throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
OG001	Risedronate	35 mg risedronate sodium orally once weekly throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.

Units	Counts

Secondary

Visual Analog Scale (VAS)

Visual analog pain scale is a measurement instrument to measure the level of hip pain. Scores range from 0 to 100 millimeter (mm) with higher score indicating greater pain. Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for type of fracture (31-A1/31-A2), type of reduction (open/close), use of opioids (Yes/No), use of non-steroidal anti-inflammatory drugs, adequate reduction (Yes/No) and interaction between treatment and adequate reduction.

All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.

Posted

Least Squares Mean

Standard Error

millimeter (mm)

6, 12, 18, and 26 Weeks

ID	Title	Description
OG000	Teriparatide	20 mcg a day by SC injection throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
OG001	Risedronate	35 mg risedronate sodium orally once weekly throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.

Secondary

Timed "Up and Go" Test

Timed "Up and Go" test measures, in seconds, the time taken by an individual to stand up from a standard chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down. Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for age, type of fracture (31-A1/31-A2), type of reduction (open/close), type of walking aid, baseline SF-36 PCS and baseline Charnley's pain score.

All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.

Posted

Least Squares Mean

Standard Error

seconds (sec)

6, 12, 18, and 26 Weeks

ID	Title	Description
OG000	Teriparatide	20 mcg a day by SC injection throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
OG001	Risedronate	35 mg risedronate sodium orally once weekly throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Bradycardia	Cardiac disorders	18.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected110 at risk
Cardiac failure	Cardiac disorders	18.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected110 at risk
Cardiac failure congestive	Cardiac disorders	18.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0012 events2 affected110 at risk
Mitral valve incompetence	Cardiac disorders	18.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected110 at risk
Retinal detachment	Eye disorders	18.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0012 events1 affected110 at risk
Oedema mouth	Gastrointestinal disorders	18.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected110 at risk
Chest pain	General disorders	18.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected110 at risk
Death	General disorders	18.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0011 events1 affected110 at risk
Device breakage	General disorders	18.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected110 at risk
Device failure	General disorders	18.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected110 at risk
Medical device complication	General disorders	18.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected110 at risk
Liver disorder	Hepatobiliary disorders	18.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected110 at risk
Gastroenteritis	Infections and infestations	18.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected110 at risk
Pneumonia	Infections and infestations	18.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0011 events1 affected110 at risk
Postoperative wound infection	Infections and infestations	18.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected110 at risk
Septic shock	Infections and infestations	18.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0011 events1 affected110 at risk
Subcutaneous abscess	Infections and infestations	18.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected110 at risk
Urinary tract infection	Infections and infestations	18.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0012 events2 affected110 at risk
Wound infection staphylococcal	Infections and infestations	18.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected110 at risk
Fall	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0006 events6 affected106 at risk EG0019 events9 affected110 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected110 at risk
Femur fracture	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected110 at risk
Forearm fracture	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected110 at risk
Head injury	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected110 at risk
Hip fracture	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0002 events2 affected106 at risk EG0014 events4 affected110 at risk
Humerus fracture	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0011 events1 affected110 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected110 at risk
Pelvic fracture	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0012 events2 affected110 at risk
Rib fracture	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected110 at risk
Subdural haematoma	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected110 at risk
Dehydration	Metabolism and nutrition disorders	18.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected110 at risk
Hyperglycaemia	Metabolism and nutrition disorders	18.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected110 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	18.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected110 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	18.0	Systematic Assessment	EG0003 events3 affected106 at risk EG0010 events0 affected110 at risk
Back pain	Musculoskeletal and connective tissue disorders	18.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected110 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	18.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected110 at risk
Amnesia	Nervous system disorders	18.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected110 at risk
Cerebral infarction	Nervous system disorders	18.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected110 at risk
Cerebrovascular accident	Nervous system disorders	18.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0012 events2 affected110 at risk
Headache	Nervous system disorders	18.0	Systematic Assessment	EG0002 events1 affected106 at risk EG0010 events0 affected110 at risk
Ischaemic stroke	Nervous system disorders	18.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected110 at risk
Monoplegia	Nervous system disorders	18.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected110 at risk
Speech disorder	Nervous system disorders	18.0	Systematic Assessment	EG0002 events1 affected106 at risk EG0010 events0 affected110 at risk
Syncope	Nervous system disorders	18.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0011 events1 affected110 at risk
Confusional state	Psychiatric disorders	18.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected110 at risk
Delirium	Psychiatric disorders	18.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected110 at risk
Bronchial polyp	Respiratory, thoracic and mediastinal disorders	18.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected110 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	18.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected110 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	18.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0010 events0 affected110 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	18.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected110 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	18.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected110 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	18.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected110 at risk
Aortic stenosis	Vascular disorders	18.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected110 at risk
Orthostatic hypotension	Vascular disorders	18.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected110 at risk
Venous thrombosis	Vascular disorders	18.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected110 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	18.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0012 events2 affected110 at risk
Abdominal pain upper	Gastrointestinal disorders	18.0	Systematic Assessment	EG0003 events3 affected106 at risk EG0011 events1 affected110 at risk
Constipation	Gastrointestinal disorders	18.0	Systematic Assessment	EG0002 events2 affected106 at risk EG0013 events3 affected110 at risk
Diarrhoea	Gastrointestinal disorders	18.0	Systematic Assessment	EG0003 events3 affected106 at risk EG0010 events0 affected110 at risk
Nausea	Gastrointestinal disorders	18.0	Systematic Assessment	EG0006 events2 affected106 at risk EG0010 events0 affected110 at risk
Bronchitis	Infections and infestations	18.0	Systematic Assessment	EG0004 events4 affected106 at risk EG0010 events0 affected110 at risk
Gastroenteritis	Infections and infestations	18.0	Systematic Assessment	EG0002 events2 affected106 at risk EG0010 events0 affected110 at risk
Influenza	Infections and infestations	18.0	Systematic Assessment	EG0002 events2 affected106 at risk EG0011 events1 affected110 at risk
Nasopharyngitis	Infections and infestations	18.0	Systematic Assessment	EG0002 events2 affected106 at risk EG0012 events2 affected110 at risk
Urinary tract infection	Infections and infestations	18.0	Systematic Assessment	EG0007 events7 affected106 at risk EG0017 events4 affected110 at risk
Viral infection	Infections and infestations	18.0	Systematic Assessment	EG0004 events3 affected106 at risk EG0010 events0 affected110 at risk
Fall	Injury, poisoning and procedural complications	18.0	Systematic Assessment	EG0008 events7 affected106 at risk EG0015 events5 affected110 at risk
Blood creatine phosphokinase increased	Investigations	18.0	Systematic Assessment	EG0002 events2 affected106 at risk EG0010 events0 affected110 at risk
Platelet count increased	Investigations	18.0	Systematic Assessment	EG0002 events2 affected106 at risk EG0010 events0 affected110 at risk
Hypercalcaemia	Metabolism and nutrition disorders	18.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0012 events2 affected110 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	18.0	Systematic Assessment	EG00016 events12 affected106 at risk EG0018 events7 affected110 at risk
Back pain	Musculoskeletal and connective tissue disorders	18.0	Systematic Assessment	EG0006 events3 affected106 at risk EG0013 events3 affected110 at risk
Bone pain	Musculoskeletal and connective tissue disorders	18.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0012 events2 affected110 at risk
Groin pain	Musculoskeletal and connective tissue disorders	18.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0012 events2 affected110 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	18.0	Systematic Assessment	EG0002 events2 affected106 at risk EG0011 events1 affected110 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	18.0	Systematic Assessment	EG0002 events2 affected106 at risk EG0012 events2 affected110 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	18.0	Systematic Assessment	EG0007 events3 affected106 at risk EG0013 events2 affected110 at risk
Dizziness	Nervous system disorders	18.0	Systematic Assessment	EG0002 events2 affected106 at risk EG0011 events1 affected110 at risk
Headache	Nervous system disorders	18.0	Systematic Assessment	EG0002 events2 affected106 at risk EG0010 events0 affected110 at risk
Delirium	Psychiatric disorders	18.0	Systematic Assessment	EG0002 events2 affected106 at risk EG0010 events0 affected110 at risk
Depression	Psychiatric disorders	18.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0013 events3 affected110 at risk
Insomnia	Psychiatric disorders	18.0	Systematic Assessment	EG0003 events3 affected106 at risk EG0011 events1 affected110 at risk
Urinary incontinence	Renal and urinary disorders	18.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0012 events2 affected110 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	18.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected23 at risk
Vulval ulceration	Reproductive system and breast disorders	18.0	Systematic Assessment	EG0000 events0 affected106 at risk EG0011 events1 affected87 at risk
Vulvovaginal dryness	Reproductive system and breast disorders	18.0	Systematic Assessment	EG0001 events1 affected81 at risk EG0010 events0 affected110 at risk
Eczema	Skin and subcutaneous tissue disorders	18.0	Systematic Assessment	EG0002 events2 affected106 at risk EG0010 events0 affected110 at risk
Rash	Skin and subcutaneous tissue disorders	18.0	Systematic Assessment	EG0001 events1 affected106 at risk EG0012 events2 affected110 at risk
Hypertension	Vascular disorders	18.0	Systematic Assessment	EG0005 events5 affected106 at risk EG0012 events2 affected110 at risk

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D010281	Parathyroid Hormone
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D004164	Diphosphonates
D063065	Organophosphonates
D009943	Organophosphorus Compounds
D009930	Organic Chemicals
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D008673	Metals, Alkaline Earth
D004602	Elements
D007287	Inorganic Chemicals
D008670	Metals
D001779	Blood Coagulation Factors
D001685	Biological Factors
D012632	Secosteroids
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

ID	Title	Description
BG000	Teriparatide	20 mcg a day by SC injection throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
BG001	Risedronate	35 mg risedronate sodium orally once weekly throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Teriparatide	20 mcg a day by SC injection throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.			21	106	53	106
EG001	Risedronate	35 mg risedronate sodium orally once weekly throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.			27	110	47	110

ID	Term
D019379	Teriparatide
D000068296	Risedronic Acid
D002118	Calcium
D014807	Vitamin D