A Study of Teriparatide in Japanese Osteoporosis Patients

Lilly

Status and phase: Completed; Phase 4

Conditions: Osteoporosis

Treatments: Drug: Teriparatide; Drug: Alfarol 1.0 µg; Drug: Aspara-CA 600 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01430104

14454

B3D-JE-GHDT (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Teriparatide + Aspara-CA + Alfarol

Experimental group

Description:

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.

Treatment:

Drug: Alfarol 1.0 µg

Drug: Aspara-CA 600 mg

Drug: Teriparatide