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 ExtremitiesChange 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
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