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

Lilly

Status and phase

Completed

Phase 4

Conditions

Osteoporosis

Treatments

Drug: teriparatide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00259298

B3D-US-GHCV (Other Identifier)

9917

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

Female

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

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