Who is sponsoring NCT01430104?

NCT01430104 is sponsored by Eli Lilly and Company.

What condition does NCT01430104 study?

NCT01430104 studies Osteoporosis.

What drugs are being tested in NCT01430104?

Interventions: Teriparatide, Aspara-CA 600 mg, Alfarol 1.0 µg.

What is the status of NCT01430104?

NCT01430104 is currently COMPLETED.

Last reviewed 2013-01-07 · How we verify

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

NCT01430104 Phase 4 COMPLETED Results posted

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.

Details

Lead sponsor	Eli Lilly and Company
Phase	Phase 4
Status	COMPLETED
Enrolment	30
Start date	2011-08
Completion	2011-12

Conditions

Osteoporosis

Interventions

Teriparatide
Aspara-CA 600 mg
Alfarol 1.0 µg

Primary outcomes

Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL) — Day 28 (16 and 24 hours postdose)
Total serum calcium concentration adjusted by serum albumin concentration. Corrected calcium (mg/dL) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter \[g/dL\]). Postdose refers to after Teriparatide dose.

Countries

Japan