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

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis, Postmenopausal

Intervention: teriparatide (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company

Summary

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.

Clinical Details

Official title: The Effects of Teriparatide on Bone Microarchitecture as Determined by High Resolution Magnetic Resonance Imaging and Digital Topological Analysis

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 18 Endpoint

Secondary outcome:

Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 24 Endpoint

Percent Change From Baseline in Cortical Thickness (CT) in the Distal Radius at Month 18 and 24 Endpoint

Percent Change From Baseline in Topological Erosion Index (TEI) in the Distal Radius at Month 18 and 24 Endpoint

Percent Change From Baseline in Bone Volume (BV)/Total Volume (TV) Ratio in the Distal Radius at Month 18 and 24 Endpoint

Percent Change From Baseline in Surface-to-Curve Ratio (SCR) at Month 3, 6, 12, 18 and 24 Endpoint

Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Lumbar Spine at Month 18 Endpoint

Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Hip at Month 18 Endpoint

Percent Change From Baseline in the Estimate of Bone Strength of Lumbar Spine at Month 18 Endpoint

Percent Change From Baseline in the Estimate of Bone Strength of Hip at Month 18 Endpoint

Percent Change From Baseline in Areal BMD at the Lumbar Spine at Month 18 and 24 Endpoint

Percent Change From Baseline in Areal BMD at the Femoral Neck at Month 18 and 24 Endpoint

Percent Change From Baseline in Areal BMD Responses at Total Hip at Month 18 and 24 Endpoint

Percent Change From Baseline in Areal BMD at ⅓ Distal Radius at Month 18 and 24 Endpoint

Percent Change From Baseline in Areal BMD at Ultra-Distal Radius at Month 18 and 24 Endpoint

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

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

Detailed description: 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.

Eligibility

Minimum age: 45 Years. Maximum age: 85 Years. Gender(s): Female.

Criteria:

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

Locations and 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., Tucson, Arizona 85704, United States

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 V6H 3X8, Canada

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 80227, United States

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 68131, United States

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 87106, United States

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 15213, United States

Additional Information

Lilly Clinical Trial Registry

Starting date: November 2007
Last updated: October 7, 2011

Page last updated: August 20, 2015

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