Overview

A Study of Teriparatide in Japanese Osteoporosis Patients

Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
Teriparatide
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