DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Evaluation of the Effects of Teriparatide on Skeleton Images in Postmenopausal Women With Osteoporosis

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

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, 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 evaluate the effects of teriparatide on skeleton images in postmenopausal women with osteoporosis. Teriparatide is a bone formation agent that stimulates the production of new bone in the skeleton. This process of bone formation can be studied using a technique commonly referred to as a bone scan or nuclear scintigraphy. This trial will test whether bone scans will identify areas of the skeleton that are forming new bone during teriparatide therapy. It also will study what these areas look like after therapy is stopped.

Clinical Details

Official title: The Use of Nuclear Scintigraphy to Evaluate the Anabolic Effects of Teriparatide on the Skeleton in Postmenopausal Women With Osteoporosis

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

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

Secondary outcome:

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

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

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

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

Eligibility

Minimum age: 50 Years. Maximum age: 85 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Ambulatory with osteoporosis

- Hip or spine bone mineral density (BMD) measurement more than 2. 5 standard deviations

below the average bone mass of young healthy women or more than 2. 0 standard deviations in women who have a history of a vertebral or nonvertebral fragility fracture. Exclusion Criteria:

- Diseases of bone other than osteoporosis

- Treatment with estrogens in the 3 months prior to enrollment or for more than 2

months in the past year

- Treatment with oral bisphosphonates in the 3 months prior to enrollment or for more

than 2 months in the past year; treatment with intravenous bisphosphonates in the 12 months prior to enrollment

- Increased risk for the development of osteosarcoma

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, London SE1 9RT, United Kingdom
Additional Information

Lilly Clinical Trial Registry

Starting date: November 2005
Last updated: July 14, 2010

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017