A Study of Teriparatide in Japanese Osteoporosis Patients

NCT ID: NCT01430104

Last Updated: 2013-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2011-12-31

Brief 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.

Conditions

Osteoporosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Teriparatide + Aspara-CA + Alfarol

Aspara-CA 600 milligrams (mg) and Alfarol 1.0 microgram (µg) administered orally once daily throughout the study. Teriparatide 20 µg administered subcutaneously once daily for 28 days during the Treatment Period.

Group Type: EXPERIMENTAL

Teriparatide

Intervention Type: DRUG

Administered subcutaneously during the Treatment Period

Aspara-CA 600 mg

Intervention Type: DRUG

Administered orally throughout the study

Alfarol 1.0 µg

Intervention Type: DRUG

Administered orally throughout the study

Interventions

Teriparatide

Administered subcutaneously during the Treatment Period

Intervention Type: DRUG

Aspara-CA 600 mg

Administered orally throughout the study

Intervention Type: DRUG

Alfarol 1.0 µg

Administered orally throughout the study

Intervention Type: DRUG

Other Intervention Names

LY333334; Forteo; Forsteo

Eligibility Criteria

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 enrollment
• 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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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

Countries

Japan

Other Identifiers

B3D-JE-GHDT

Identifier Type: OTHER

Identifier Source: secondary_id

14454

Identifier Type: -

Identifier Source: org_study_id