CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 30 enrolled
Drug / intervention
Teriparatide +2 moredrug
Likely dose
Aspara-CA 600 mgfrom 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/NCT01430104
NCT01430104Phase 4Completed
CompareCT.gov

A Study to Assess the Effects on Serum Calcium When Teriparatide is Used With Active Vitamin D in Osteoporosis Patients

Eli Lilly and Company·interventional·Posted Sep 7, 2011·Updated Jan 14, 2013

In Brief

A Phase 4 clinical trial evaluating Teriparatide, Aspara-CA 600 mg, and 1 other intervention for Osteoporosis. Completed, enrolled 30 participants across 1 site.

Detailed Summary

The purpose of this trial is to assess the effects on serum calcium when teriparatide is used with active vitamin D in osteoporosis patients. This study consists of a Screening Period, a 14-day Lead-in Period, a 28-day Treatment Period, and a 7-day Follow-up Period. Patients will take vitamin D and calcium supplementation from the Lead-in Period throughout the study. During the Treatment Period, daily administration of teriparatide will be added.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoporosis
CountriesJapan
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 7, 2011
Enrollment StartAug 1, 2011
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 14.8 years ago

Interventions

Teriparatidedrug

Administered subcutaneously during the Treatment Period

Aspara-CA 600 mgdrug

Administered orally throughout the study

Alfarol 1.0 µgdrug

Administered orally throughout the study