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

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Teriparatide

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