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

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: Female

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.

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

Details

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

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