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

NCT ID: NCT00557310

Last Updated: 2011-11-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2011-05-31

Brief Summary

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The purpose of this study is to use imaging technologies to demonstrate the effects of teriparatide on bone structure following 18 to 24 months of therapy in postmenopausal women with osteoporosis.

Detailed Description

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As teriparatide is approved for up to 24 months of treatment in the US, patients will be given the option to continue in a 6-month extension phase upon completion of 18 months of teriparatide treatment. This extension will allow for collection of additional bone quality data. In Canada, the use of teriparatide is currently approved for 18 months. Patients in Canada may be given the opportunity to participate in the 6-month extension phase, contingent upon Health Canada approval of the use of teriparatide treatment for 24 months.

Conditions

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Osteoporosis, Postmenopausal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Teriparatide

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

Group Type EXPERIMENTAL

teriparatide

Intervention Type DRUG

20 mcg teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months

Interventions

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teriparatide

20 mcg teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months

Intervention Type DRUG

Other Intervention Names

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LY333334 FORTEO FORSTEO

Eligibility Criteria

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Inclusion Criteria

* postmenopausal (after the "change of life") women with osteoporosis
* between the ages of 45-85
* have low bone mass as determined by a bone density test
* have at least one prior atraumatic vertebral or nonvertebral fracture(with a T-score of -2.0 or lower at the lumbar spine, total hip, or femoral neck) or, no prior fracture (with a T-score of -3.0 or lower at these same sites)
* could have taken up to 5 years total of certain oral osteoporosis medications such as alendronate, risedronate, or ibandronate

Exclusion Criteria

* have conditions that would affect the bone in the region of the wrist or have had a previous fracture of either wrist which might affect results of study
* have a metal implant or have had a hip replacement in either hip which might affect results of study
* have an increased risk of osteosarcoma; includes Paget's disease of bone, a previous bone tumor, or x-ray treatment to the skeleton
* currently have active or suspected diseases that affect the bone, other than osteoporosis
* have abnormal levels of calcium, parathyroid hormone in blood, or other laboratory values
Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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.

Tucson, Arizona, United States

Site Status

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.

Lakewood, Colorado, United States

Site Status

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.

Omaha, Nebraska, United States

Site Status

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.

Albuquerque, New Mexico, United States

Site Status

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.

Pittsburgh, Pennsylvania, United States

Site Status

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.

Vancouver, British Columbia, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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B3D-US-GHDJ

Identifier Type: OTHER

Identifier Source: secondary_id

11996

Identifier Type: -

Identifier Source: org_study_id