Evaluation of the Effects of Teriparatide on Skeleton Ima... | NCT00259298

ID	Type	Description	Link
B3D-US-GHCV	Other Identifier	Eli Lilly and Company

Evaluation of the Effects of Teriparatide on Skeleton Ima... | NCT00259298 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Teriparatide	Experimental	Participants receive teriparatide 20 microgram once daily by subcutaneous injection for 18 months followed by 6 months off therapy	Drug: teriparatide

Name	Type	Description	Arm Group Labels	Other Names
teriparatide	Drug	Subcutaneous, 20 microgram (mcg)/day, 18 months	Teriparatide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Whole Skeleton Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) to 18 Months	Skeletal plasma clearance is defined as the volume of plasma cleared of tracer (99m Tc-MDP) by the skeleton per unit time (milliliter/minute). Kbone is the rate constant representing plasma clearance of tracer to bone. The Patlak plot method was used to evaluate whole skeleton 99mTc-MDP skeletal plasma clearance (Kbone).	baseline, 18 months

Secondary Outcomes

Measure	Description	Time Frame
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities	Skeletal plasma clearance is defined as the volume of plasma cleared of tracer (99m Tc-MDP) by the skeleton per unit time (milliliter/minute). Kbone is the rate constant representing plasma clearance of tracer to bone. The Patlak plot method was used to evaluate whole skeleton 99mTc-MDP skeletal plasma clearance (Kbone) and to derive regional values for the skull, mandible, spine, pelvis, and upper and lower extremities.

Contacts/Locations Module

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

Locations

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		London		SE1 9RT

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19929434	Derived	Moore AE, Blake GM, Taylor KA, Rana AE, Wong M, Chen P, Fogelman I. Assessment of regional changes in skeletal metabolism following 3 and 18 months of teriparatide treatment. J Bone Miner Res. 2010 May;25(5):960-7. doi: 10.1359/jbmr.091108.

ID	Title	Description
FG000	Teriparatide	Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00012 subjects
Received at Least 1 Dose of Study Drug		FG00010 subjects
COMPLETED		FG0009 subjects
NOT COMPLETED		FG0003 subjects

Type	Comment	Reasons
Withdrawal by Subject		FG0001 subjects
Physician Decision		FG0002 subjects

Baseline Characteristics Module

ID	Title	Description
BG000	Teriparatide	Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age Continuous			Mean

Outcome Measures Module

Outcome Measures

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

Secondary

Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities

Skeletal plasma clearance is defined as the volume of plasma cleared of tracer (99m Tc-MDP) by the skeleton per unit time (milliliter/minute). Kbone is the rate constant representing plasma clearance of tracer to bone. The Patlak plot method was used to evaluate whole skeleton 99mTc-MDP skeletal plasma clearance (Kbone) and to derive regional values for the skull, mandible, spine, pelvis, and upper and lower extremities.

All participants with a baseline observation and at least 1 post-baseline observation.

Posted

Median

Inter-Quartile Range

percentage of change of plasma clearance

Baseline, 3 months, 18 months, 24 months

ID	Title	Description
OG000	Teriparatide	Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy

Adverse Events Module

Arm/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	Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Chest pain	General disorders	MedDRA 12.0	Systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Arrhythmia	Cardiac disorders	MedDRA 12.0	Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Chief Medical Officer	Eli Lilly and Company	800-545-5979

Condition Browse Module

ID	Term
D010024	Osteoporosis

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases

Intervention Browse Module

ID	Term
D019379	Teriparatide

ID	Term
D010281	Parathyroid Hormone
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

Qualitative Visual Assessment of Diffuse Uptake of 99m Technetium methylene diphosphonate

Presented are data only for participants who received a bone scan at baseline. Initial bone scans for each participant were evaluated by a radiologist for an increase in diffuse uptake in the whole skeleton compared to expected values in a healthy population. Subjective visual assessment categorized results into no increase, possible increase, and definite increase.

Number

participants

Title

Denominators

Categories

no increase

Title	Measurements
	BG00010

possible increase

Title	Measurements
	BG0000

definite increase

Title	Measurements
	BG0000

not assessed

Title	Measurements
	BG0002

Qualitative Visual Score of Focal uptake of 99m Technetium methylene diphosphonate (99m Tc-MDP)

Changes in focal uptake (localized, defined areas of uptake) in the whole skeleton were visually scored. Changes were rated on a scale from 0-4: 0=no clinically significant focal areas of skeletal uptake; 1=focal areas affecting <1% of skeleton; 2=focal areas affecting >=5% of skeleton; 3=focal areas affecting >=20% of skeleton; 4=focal areas affecting >=50% of skeleton.

Mean

Standard Deviation

units on scale

Title

Denominators

Categories

Title	Measurements
	BG0000.7± 0.48

Skeletal plasma clearance of 99m Technetium methylene diphosphonate (99m Tc-MDP)

Median

Inter-Quartile Range

milliliter/minute

Title

Denominators

Categories

whole skeleton

Title	Measurements
	BG00038.30(33.00 to 40.90)

skull

Title	Measurements
	BG0003.07(2.43 to 3.74)

mandible

Title	Measurements
	BG0000.17(0.13 to 0.24)

spine

Title	Measurements
	BG0006.32(4.88 to 7.00)

pelvis

Title	Measurements
	BG0005.92(5.78 to 6.77)

upper extremities

Title	Measurements
	BG0003.70(3.41 to 5.15)

lower extremities

Title	Measurements
	BG0009.12(7.82 to 9.86)

Skeletal uptake of 99m Technetium methylene diphosphonate (99m Tc-MDP)

Skeletal uptake describes the percent uptake of radionuclide tracer by the skeleton. Skeletal uptake is defined as percentage of uptake of 99mTc-MDP 4 hours after injection. This value differs from skeletal plasma clearance measurements because it only quantifies the amount of 99mTc-MDP taken up by bone without consideration of concentration of tracer in the plasma.

Median

Inter-Quartile Range

percentage of uptake

Title

Denominators

Categories

whole skeleton

Title	Measurements
	BG00029.4(27.40 to 31.70)

skull

Title	Measurements
	BG0002.59(1.96 to 2.95)

mandible

Title	Measurements
	BG0000.14(0.12 to 0.19)

spine

Title	Measurements
	BG0004.85(3.87 to 5.68)

pelvis

Title	Measurements
	BG0004.57(4.06 to 5.28)

upper extremities

Title	Measurements
	BG0002.98(2.29 to 3.81)

lower extremities

Title	Measurements
	BG0007.09(6.27 to 8.46)

Title

Denominators

Categories

Whole skeleton, baseline to 3 months, n=10

Title	Measurements
	OG00025.02(14.21 to 30.73)

Whole skeleton, baseline to 24 months, n=9

Title	Measurements
	OG0003.52(-8.27 to 11.93)

Whole skeleton, 3 months to 18 months, n=10

Title	Measurements
	OG00010.44(7.83 to 21.00)

Whole skeleton, 18 months to 24 months, n=9

Title	Measurements
	OG000-22.20(-24.35 to -18.39)

Skull, baseline to 3 months, n=8

Title	Measurements
	OG00072.25(42.19 to 106.56)

Skull, baseline to 18 months, n=8

Title	Measurements
	OG000128.44(97.38 to 162.55)

Skull, baseline to 24 months, n=7

Title	Measurements
	OG00021.20(8.00 to 54.90)

Skull, 3 months to 18 months, n=8

Title	Measurements
	OG00031.01(17.65 to 47.29)

Skull, 18 months to 24 months, n=7

Title	Measurements
	OG000-37.87(-45.64 to -32.14)

Mandible, baseline to 3 months, n=8

Title	Measurements
	OG00065.94(26.56 to 106.76)

Mandible, baseline to 18 months, n=8

Title	Measurements
	OG00060.99(31.25 to 127.78)

Mandible, baseline to 24 months, n=7

Title	Measurements
	OG00021.05(-6.90 to 82.35)

Mandible, 3 months to 18 months, n=8

Title	Measurements
	OG0004.55(-3.25 to 15.13)

Mandible, 18 months to 24 months, n=7

Title	Measurements
	OG000-17.39(-25.81 to -10.00)

Spine, baseline to 3 months, n=10

Title	Measurements
	OG00017.31(0.46 to 35.53)

Spine, baseline to 18 months, n=10

Title	Measurements
	OG00033.81(7.53 to 57.99)

Spine, baseline to 24 months, n=9

Title	Measurements
	OG00016.94(-0.14 to 32.99)

Spine, 3 months to 18 months, n=10

Title	Measurements
	OG00014.10(-0.23 to 20.00)

Spine, 18 months to 24 months, n=9

Title	Measurements
	OG000-9.42(-15.31 to 8.31)

Pelvis, baseline to 3 months, n=10

Title	Measurements
	OG00020.26(5.00 to 43.59)

Pelvis, baseline to 18 months, n=10

Title	Measurements
	OG0008.36(4.15 to 28.23)

Pelvis, baseline to 24 months, n=9

Title	Measurements
	OG000-5.58(-14.19 to 10.65)

Pelvis, 3 months to 18 months, n=10

Title	Measurements
	OG000-3.29(-15.75 to 2.15)

Pelvis, 18 months to 24 months, n=9

Title	Measurements
	OG000-13.81(-17.61 to 2.26)

Upper extremities, baseline to 3 months, n=10

Title	Measurements
	OG00042.52(8.92 to 91.09)

Upper extremities, baseline to 18 months, n=10

Title	Measurements
	OG00095.49(62.52 to 146.10)

Upper extremities, baseline to 24 months, n=9

Title	Measurements
	OG00062.76(31.07 to 70.24)

Upper extremities, 3 months to 18 months, n=10

Title	Measurements
	OG00045.84(24.27 to 77.33)

Upper extremities, 18 months to 24 months, n=9

Title	Measurements
	OG000-19.35(-27.59 to 1.18)

Lower extremities, baseline to 3 months, n=10

Title	Measurements
	OG00020.98(3.71 to 50.16)

Lower extremities, baseline to 18 months, n=10

Title	Measurements
	OG00034.88(16.65 to 67.09)

Lower extremities, baseline to 24 months, n=9

Title	Measurements
	OG0007.07(-8.08 to 15.77)

Lower extremities, 3 months to 18 months, n=10

Title	Measurements
	OG00012.72(-12.14 to 24.74)

Lower extremities, 18 months to 24 months, n=9

Title	Measurements
	OG000-20.72(-21.81 to -13.55)

Group IDs	Group Description	Statistical Method	P-Value	P-Value Comment	Confidence Interval %	Tested Non-Inferiority	Non-Inferiority Type
OG000	Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the skull from baseline to 3 months.	Wilcoxon signed rank test	0.0078	p-value is for skull, baseline to 3 months	95	No	Superiority or Other
OG000	Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the skull from baseline to 18 months.	Wilcoxon signed rank test	0.0078	p-value is for skull, baseline to 18 months	95	No	Superiority or Other
OG000	Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the skull from baseline to 24 months.	Wilcoxon signed rank test	0.0313	p-value is for skull, baseline to 24 months	95	No	Superiority or Other
OG000	Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the skull from 3 months to 18 months.	Wilcoxon signed rank test	0.0078	p-value is for skull, 3 months to 18 months	95	No	Superiority or Other
OG000	Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the skull from 18 months to 24 months.	Wilcoxon signed rank test	0.0156	p-value is for skull, 18 months to 24 months	95	No	Superiority or Other
OG000	Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the mandible from baseline to 3 months.	Wilcoxon signed rank test	0.0156	p-value is for mandible, baseline to 3 months	95	No	Superiority or Other
OG000	Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the mandible from baseline to 18 months.	Wilcoxon signed rank test	0.0078	p-value is for mandible, baseline to 18 months	95	No	Superiority or Other
OG000	Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the mandible from baseline to 24 months.	Wilcoxon signed rank test	0.1563	p-value is for mandible, baseline to 24 months	95	No	Superiority or Other
OG000	Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the mandible from 3 months to 18 months.	Wilcoxon signed rank test	0.4375	p-value is for mandible, 3 months to 18 months	95	No	Superiority or Other
OG000	Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the mandible from 18 months to 24 months.	Wilcoxon signed rank test	0.0781	p-value is for mandible, 18 months to 24 months	95	No	Superiority or Other
OG000	Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the spine from baseline to 3 months.	Wilcoxon signed rank test	0.0371	p-value is for spine, baseline to 3 months	95	No	Superiority or Other
OG000	Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the spine from baseline to 18 months.	Wilcoxon signed rank test	0.0137	p-value is for spine, baseline to 18 months	95	No	Superiority or Other
OG000	Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the spine from baseline to 24 months.	Wilcoxon signed rank test	0.0547	p-value is for spine, baseline to 24 months	95	No	Superiority or Other
OG000	Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the spine from 3 months to 18 months.	Wilcoxon signed rank test	0.0488	p-value is for spine, 3 months to 18 months	95	No	Superiority or Other
OG000	Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the spine from 18 months to 24 months.	Wilcoxon signed rank test	0.3594	p-value is for spine, 18 months to 24 months	95	No	Superiority or Other
OG000	Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the pelvis from baseline to 3 months.	Wilcoxon signed rank test	0.0488	p-value is for pelvis, baseline to 3 months	95	No	Superiority or Other
OG000	Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the pelvis from baseline to 18 months.	Wilcoxon signed rank test	0.1055	p-value is for pelvis, baseline to 18 months	95	No	Superiority or Other
OG000	Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the pelvis from baseline to 24 months.	Wilcoxon signed rank test	0.9102	p-value is for pelvis, baseline to 24 months	95	No	Superiority or Other
OG000	Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the pelvis from 3 months to 18 months.	Wilcoxon signed rank test	0.1934	p-value is for pelvis, 3 months to 18 months	95	No	Superiority or Other
OG000	Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the pelvis from 18 months to 24 months.	Wilcoxon signed rank test	0.1641	p-value is for pelvis, 18 months to 24 months	95	No	Superiority or Other
OG000	Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from baseline to 3 months.	Wilcoxon signed rank test	0.0137	p-value is for upper extremities, baseline to 3 months	95	No	Superiority or Other
OG000	Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from baseline to 18 months.	Wilcoxon signed rank test	0.0020	p-value is for upper extremities, baseline to 18 months	95	No	Superiority or Other
OG000	Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from baseline to 24 months.	Wilcoxon signed rank test	0.0039	p-value is for upper extremities, baseline to 24 months	95	No	Superiority or Other
OG000	Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from 3 months to 18 months.	Wilcoxon signed rank test	0.0273	p-value is for upper extremities, 3 months to 18 months	95	No	Superiority or Other
OG000	Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the upper extremities from 18 months to 24 months.	Wilcoxon signed rank test	0.0547	p-value is for upper extremities, 18 months to 24 months	95	No	Superiority or Other
OG000	Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from baseline to 3 months.	Wilcoxon signed rank test	0.0195	p-value is for lower extremities, baseline to 3 months	95	No	Superiority or Other
OG000	Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from baseline to 18 months.	Wilcoxon signed rank test	0.0059	p-value is for lower extremities, baseline to 18 months	95	No	Superiority or Other
OG000	Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from baseline to 24 months.	Wilcoxon signed rank test	0.5703	p-value is for lower extremities, baseline to 24 months	95	No	Superiority or Other
OG000	Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from 3 months to 18 months.	Wilcoxon signed rank test	0.1934	p-value is for lower extremities, 3 months to 18 months	95	No	Superiority or Other
OG000	Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the lower extremities from 18 months to 24 months.	Wilcoxon signed rank test	0.0039	p-value is for lower extremities, 18 months to 24 months	95	No	Superiority or Other
OG000	Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the whole body from baseline to 3 months.	Wilcoxon signed rank test	0.0039	p-value is for whole body, baseline to 3 months	95	No	Superiority or Other
OG000	Tested was the hypothesis that there would be no change in skeletal plasma clearance of 99m Tc-MDP in the whole body from baseline to 24 months.	Wilcoxon signed rank test	0.5703	p-value is for whole body, baseline to 24 months	95	No	Superiority or Other
OG000	Tested was the hypothesis that there would be no increase in skeletal plasma clearance of 99m Tc-MDP in the whole body from 3 months to 18 months.	Wilcoxon signed rank test	0.0273	p-value is for whole body, 3 months to 18 months	95	No	Superiority or Other
OG000	Tested was the hypothesis that there would be no decrease in skeletal plasma clearance of 99m Tc-MDP in the whole body from 18 months to 24 months.	Wilcoxon signed rank test	0.0039	p-value if for whole body, 18 months to 24 months	95	No	Superiority or Other

Secondary

Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities

Skeletal uptake describes the percent uptake of radionuclide tracer by the skeleton when compared to baseline or other post-baseline measures. Skeletal uptake is defined as percentage of uptake of 99mTc-MDP 4 hours after injection. This value differs from skeletal plasma clearance measurements because it only quantifies the amount of 99mTc-MDP taken up by bone without consideration of concentration of tracer in the plasma.

All participants with a baseline observation and at least 1 post-baseline observation.

Posted

Median

Inter-Quartile Range

percentage of change of skeletal uptake

Baseline, 3 months, 18 months, 24 months

ID	Title	Description
OG000	Teriparatide	Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy

Units	Counts
Participants	OG00010

Title

Denominators

Categories

whole skeleton, baseline to 3 months, n=10

Title	Measurements
	OG00015.63(4.93 to 28.89)

whole skeleton, baseline to 18 months, n=10

Title	Measurements
	OG00026.12(11.81 to 37.31)

whole skeleton, baseline to 24 months, n=9

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	Tested was the hypothesis that there would be no increase in skeletal uptake of 99m Tc-MDP in the whole skeleton from baseline to 3 months.	Wilcoxon signed rank test		0.0098	p-value is for whole skeleton, baseline to 3 months						95						No	Superiority or Other
OG000

Secondary

Change in Qualitative Visual Scores of Focal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton

Changes in focal uptake (localized, defined areas of uptake) were visually scored and compared to baseline or other post-baseline assessments. Changes were rated on a scale from 0-4: 0=no clinically significant focal areas of skeletal uptake; 1=focal areas affecting <1% of skeleton; 2=focal areas affecting >=5% of skeleton; 3=focal areas affecting >=20% of skeleton; 4=focal areas affecting >=50% of skeleton.

All participants with a baseline observation and at least 1 post-baseline observation.

Posted

Mean

Standard Deviation

units on a scale

Baseline, 3 months, 18 months, 24 months

ID	Title	Description
OG000	Teriparatide	Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy

Units	Counts
Participants	OG00010

Title

Denominators

Categories

focal change, baseline to 3 months, n=10

Title	Measurements
	OG0000.1± 0.32(0 to 0)

focal change, baseline to 18 months, n=10

Title	Measurements
	OG0000.1± 0.32(0.0 to 0.0)

focal change, baseline to 24 months, n=9

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	Tested was the hypothesis that there would be no increase in focal skeletal uptake of 99m Tc-MDP from baseline to 3 months.	Wilcoxon signed rank test		1.0	p-value is for focal change, baseline to 3 months						95						No	Superiority or Other
OG000	Tested was the hypothesis that there would be no increase in focal skeletal uptake of 99m Tc-MDP from baseline to 18 months.

Secondary

Number of Participants With Changes in Diffuse Uptake of 99m Tc-MDP - Qualitative Visual Assessment in the Whole Skeleton

Changes in diffuse uptake were determined by comparing diffuse uptake to baseline or other post-baseline observations. Diffuse uptake indicates response to therapy (during active treatment, increased diffuse uptake was expected; after the 6-month withdrawal period, decreased diffuse uptake was expected). Qualitative visual scoring of changes in the bone scan images were performed jointly by 3 reviewers who classified changes in the whole skeleton into 4 groups as follows: possible decreased response, no response, possible response, and definite response.

All participants with a baseline observation and at least 1 post-baseline observation.

Posted

Number

participants

baseline, 3 months, 18 months, 24 months

ID	Title	Description
OG000	Teriparatide	Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy

Units	Counts
Participants	OG00010

Title

Denominators

Categories

3 months, no response

Title	Measurements
	OG0002

3 months, possible response

Title	Measurements
	OG0002

3 months, definite response

Primary

Change From Baseline in Whole Skeleton Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) to 18 Months

All participants with a baseline observation and at least 1 post-baseline observation.

Posted

Median

Inter-Quartile Range

percentage of change of plasma clearance

baseline, 18 months

ID	Title	Description
OG000	Teriparatide	Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy

Units	Counts
Participants	OG00010

Title

Denominators

Categories

Title	Measurements
	OG00033.75(29.97 to 50.91)

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	Tested was the hypothesis that there would be no increase in whole skeletal plasma clearance of 99m Tc-MDP from baseline to 18 months.	Wilcoxon signed rank test		0.0020	p-value is for change at 18 months						95						No	Superiority or Other