A Study Using Imaging Technology to Measure Changes in Bone Structure After Treatment With Teriparatide

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT00557310

First received: November 9, 2007

Last updated: October 7, 2011

Last verified: October 2011

History of Changes

Results First Received: October 7, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Osteoporosis, Postmenopausal
Intervention:	Drug: teriparatide

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who completed the 18 month main study had an option to continue treatment for an additional 6 months (Extension Phase).

Reporting Groups

	Description
Teriparatide	20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months

Participant Flow for 2 periods

Period 1: Main Study (0 - 18 Months)

	Teriparatide
STARTED	35
COMPLETED	30 ^[1]
NOT COMPLETED	5
Adverse Event	4
Withdrawal by Subject	1

[1]	One had a metal hip implant, a protocol violation, and was excluded from efficacy analyses.

Period 2: Extension Phase (18 - 24 Months)

	Teriparatide
STARTED	30
COMPLETED	25 ^[1]
NOT COMPLETED	5
Adverse Event	1
Lost to Follow-up	1
Physician Decision	2
Protocol Violation	1

[1]	One had a metal hip implant, a protocol violation, and was excluded from efficacy analyses.

Baseline Characteristics

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Reporting Groups

	Description
Teriparatide	20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months

Baseline Measures

	Teriparatide
Number of Participants [units: participants]	34
Age [units: years] Mean ± Standard Deviation	61.96 ± 8.14
Gender [units: participants]
Female	34
Male	0
Race/Ethnicity, Customized [units: participants]
Caucasian	31
Hispanic	2
West Asian	1
Region of Enrollment [units: participants]
United States	28
Canada	6
Dominant Hand [units: participants]
Left	1
Right	33
Prevalent Fractures ^[1] [units: participants]
None	14
Any vertebral fracture	4
Any non-vertebral fracture	17
Years Postmenopausal [units: years] Mean ± Standard Deviation	16.97 ± 12.10
Prior Bisphosphonate Use [units: participants]
Yes	21
No	13
Lumbar Spine T-Score ^[2] [units: units on a scale] Mean ± Standard Deviation	-2.91 ± 1.04
Femoral Neck T-Score [units: units on a scale] Mean ± Standard Deviation	-2.38 ± 0.67
Total Hip T-Score [units: units on a scale] Mean ± Standard Deviation	-1.80 ± 0.81

[1]	A prevalent fracture is defined as a fracture that a participant already had at the time of study entry. One participant had both a vertebral and non-vertebral fracture and therefore the total number of participants is higher than the baseline population number.
[2]	The T-score is a comparison of a patient's bone mineral density (BMD) to that of the mean BMD for a healthy population of women at peak bone mass (30 years). A normal T-score has a value of -1.0 or higher. Osteoporosis is defined as a T-score of -2.5 or lower, meaning a bone mineral density that is two and a half standard deviations below the mean BMD of a healthy population of women at peak bone mass (30 years).

[1]

A prevalent fracture is defined as a fracture that a participant already had at the time of study entry. One participant had both a vertebral and non-vertebral fracture and therefore the total number of participants is higher than the baseline population number.

[2]

The T-score is a comparison of a patient's bone mineral density (BMD) to that of the mean BMD for a healthy population of women at peak bone mass (30 years). A normal T-score has a value of -1.0 or higher. Osteoporosis is defined as a T-score of -2.5 or lower, meaning a bone mineral density that is two and a half standard deviations below the mean BMD of a healthy population of women at peak bone mass (30 years).

Outcome Measures

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1. Primary:

Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 18 Endpoint [ Time Frame: Baseline, 18 months ]

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2. Secondary:

Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 24 Endpoint [ Time Frame: Baseline, 24 months ]

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3. Secondary:

Percent Change From Baseline in Cortical Thickness (CT) in the Distal Radius at Month 18 and 24 Endpoint [ Time Frame: Baseline, 18, 24 months ]

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4. Secondary:

Percent Change From Baseline in Topological Erosion Index (TEI) in the Distal Radius at Month 18 and 24 Endpoint [ Time Frame: Baseline, 18, 24 months ]

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5. Secondary:

Percent Change From Baseline in Bone Volume (BV)/Total Volume (TV) Ratio in the Distal Radius at Month 18 and 24 Endpoint [ Time Frame: Baseline, 18, 24 months ]

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6. Secondary:

Percent Change From Baseline in Surface-to-Curve Ratio (SCR) at Month 3, 6, 12, 18 and 24 Endpoint [ Time Frame: Baseline, 3, 6, 12, 18, 24 months ]

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7. Secondary:

Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Lumbar Spine at Month 18 Endpoint [ Time Frame: Baseline, 18 months ]

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8. Secondary:

Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Hip at Month 18 Endpoint [ Time Frame: Baseline, 18 months ]

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9. Secondary:

Percent Change From Baseline in the Estimate of Bone Strength of Lumbar Spine at Month 18 Endpoint [ Time Frame: Baseline, 18 months ]

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10. Secondary:

Percent Change From Baseline in the Estimate of Bone Strength of Hip at Month 18 Endpoint [ Time Frame: Baseline, 18 months ]

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Measure Type	Secondary
Measure Title	Percent Change From Baseline in the Estimate of Bone Strength of Hip at Month 18 Endpoint
Measure Description	Finite Element Analysis of computed tomography (CT) data from hip is used to estimate the strength of the proximal femur with a virtual sideways fall. Least squares (LS) mean of the percent change from baseline to 18 months is from an analysis of variance (ANOVA). The model included terms for investigator site and prior bisphosphonate use.
Time Frame	Baseline, 18 months
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who were assigned to treatment, had non-missing baseline and at least one non-missing post-baseline measurement value.

Reporting Groups

	Description
Teriparatide	20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months

Measured Values

	Teriparatide
Number of Participants Analyzed [units: participants]	25
Percent Change From Baseline in the Estimate of Bone Strength of Hip at Month 18 Endpoint [units: % change of Newtons] Least Squares Mean ± Standard Error	2.54 ± 1.18

Statistical Analysis 1 for Percent Change From Baseline in the Estimate of Bone Strength of Hip at Month 18 Endpoint

Groups ^[1]	Teriparatide
Method ^[2]	ANOVA
P Value ^[3]	0.045

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
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[2]	Other relevant information, such as adjustments or degrees of freedom:
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[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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11. Secondary:

Percent Change From Baseline in Areal BMD at the Lumbar Spine at Month 18 and 24 Endpoint [ Time Frame: Baseline, 18, 24 months ]

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12. Secondary:

Percent Change From Baseline in Areal BMD at the Femoral Neck at Month 18 and 24 Endpoint [ Time Frame: Baseline, 18, 24 months ]

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13. Secondary:

Percent Change From Baseline in Areal BMD Responses at Total Hip at Month 18 and 24 Endpoint [ Time Frame: Baseline, 18, 24 months ]

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14. Secondary:

Percent Change From Baseline in Areal BMD at ⅓ Distal Radius at Month 18 and 24 Endpoint [ Time Frame: Baseline, 18, 24 months ]

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15. Secondary:

Percent Change From Baseline in Areal BMD at Ultra-Distal Radius at Month 18 and 24 Endpoint [ Time Frame: Baseline, 18, 24 months ]

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16. Secondary:

Percent Change From Baseline in Serum Procollagen Type I N-Terminal Propeptide (PINP) at Month 3, 6 and 24 Endpoint [ Time Frame: Baseline, 3, 6, 24 months ]

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17. Secondary:

Percent Change From Baseline in Serum Carboxyterminal Cross-Linking Telopeptide of Type I Collagen (CTX) at Month 3, 6 and 24 Endpoint [ Time Frame: Baseline, 3, 6, 24 months ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979

No publications provided

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00557310 History of Changes
Other Study ID Numbers:	11996, B3D-US-GHDJ
Study First Received:	November 9, 2007
Results First Received:	October 7, 2011
Last Updated:	October 7, 2011
Health Authority:	United States: Institutional Review Board Canada: Ethics Review Committee

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