NCT00927186

Effects of Teriparatide or Zoledronic Acid Treatment on Bone in Postmenopausal Osteoporotic Women

Skeletal Histomorphometry in Patients on Teriparatide or Zoledronic Acid Therapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: Female
• Age: 55 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate how teriparatide or zoledronic acid affects the bone of postmenopausal osteoporotic women after 6 months of treatment as determined by a bone biopsy sample taken from the iliac crest (upper part of the pelvis). After completing 12 months of treatment all participants are eligible to participate in an additional 12-month open label extension.

Conditions

• Osteoporosis, Post-menopausal

Interventions

Type	Name	Description
DRUG	Teriparatide	20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
DRUG	Zoledronic Acid	5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-10-01
• Completion: 2012-04-01
• First posted: 2009-06-24
• Last updated: 2013-04-04
• Results posted: 2012-03-02

Locations

12 sites across 2 countries: United States, Canada