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

Lilly

Status and phase: Completed; Phase 4

Conditions: Osteoporosis, Postmenopausal

Treatments: Drug: teriparatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00557310

11996

B3D-US-GHDJ (Other Identifier)

Details and patient eligibility

About

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.

Full description

As teriparatide is approved for up to 24 months of treatment in the US, patients will be given the option to continue in a 6-month extension phase upon completion of 18 months of teriparatide treatment. This extension will allow for collection of additional bone quality data. In Canada, the use of teriparatide is currently approved for 18 months. Patients in Canada may be given the opportunity to participate in the 6-month extension phase, contingent upon Health Canada approval of the use of teriparatide treatment for 24 months.

Enrollment: 35 patients

Sex: Female

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Teriparatide

Experimental group

Description:

20 micrograms (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months

Treatment:

Drug: teriparatide