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A Study of Teriparatide in Japanese Osteoporosis Patients

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoporosis

Intervention: Teriparatide (Drug); Aspara-CA 600 mg (Drug); Alfarol 1.0 µg (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company


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.

Clinical Details

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

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL)

Secondary outcome:

Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL) and 13.5 mg/dL, Respectively at Any Time Postbaseline

Mean Serum Calcium Levels

Change From Baseline in Serum Calcium

Number of Participants With Daily Urine Calcium Excreted Over 0.3 Grams Per Day (g/Day) at Any Time Postbaseline

Mean Daily Urine Calcium Excreted

Change From Baseline in Daily Urine Calcium Excreted

Concentrations of Serum 25-Hydroxy-Vitamin D

Concentrations of Serum 1,25-Hydroxy-2-Vitamin D3


Minimum age: 55 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Ambulatory Japanese males or postmenopausal females with osteoporosis, as determined

by the Japanese Society for Bone and Mineral Research (JSBMR) diagnostic criteria Exclusion Criteria:

- Prior treatment with parathyroid hormone (PTH) or any PTH analog

- History of metabolic bone disorders other than primary osteoporosis

- Fractures caused by diseases other than osteoporosis

- Abnormal thyroid function

- Hyperparathyroidism or hypoparathyroidism

- Severe or chronically disabling conditions other than osteoporosis

- Currently has or has a history of spruce, inflammatory bowel disease, or

malabsorption syndrome

- Currently has, or a has a history of, nephrolithiasis or urolithiasis in the 2 years

prior to screening

- Clinically significant abnormal laboratory values or electrocardiogram

- Treatment with oral bisphosphonates at any time in the 3 months prior to enrollment,

treatment with any bisphosphonate for more than 60 days in the 6 months prior to enrollment, or with intravenous bisphosphonates at any time in the 24 months prior to enrollment; or in case of oral bisphosphonates administered once a week, the equivalent as the above

- Treatment with injectable calcitonin in the 3 months prior to enrollment

- Treatment with raloxifene hydrochloride for more than 3 months in the 6 months prior

to enrollment

- Treatment with systemic corticosteroids, except for orally inhaled or nasally inhaled

corticosteroids, in doses <= 800 micrograms per day (µg/day) beclomethasone dipropionate or equivalent in the 3 months prior to screening, or for more than 30 days in the 12 months prior to enrollment

- Treatment with anticonvulsants, except for benzodiazepines, in the 6 months prior to


- Prior treatment with strontiumranate or denosumab (anti-RANKL antibody)

- Prior external beam radiation therapy involving the skeleton

- Current or a history of malignant neoplasm in the 5 years prior to screening, with

the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that had been definitively treated

Locations and Contacts

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Tokyo, Japan
Additional Information

Starting date: August 2011
Last updated: January 7, 2013

Page last updated: August 20, 2015

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