CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 69 enrolled
Drug / intervention
Teriparatide +1 moredrug
Likely dose
Teriparatide 20 microgramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00927186
NCT00927186Phase 4Completed

Skeletal Histomorphometry in Patients on Teriparatide or Zoledronic Acid Therapy

Eli Lilly and Company·interventional·Posted Jun 24, 2009·Updated Apr 4, 2013

In Brief

A Phase 4 clinical trial evaluating Teriparatide and Zoledronic Acid for Osteoporosis, Post-menopausal. Completed, enrolled 69 participants across 12 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 24, 2009
Enrollment StartJul 1, 2009
Primary CompletionOct 1, 2010
Study CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.0 years ago

Interventions

Teriparatidedrug

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.

Zoledronic Aciddrug

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.