Status:
COMPLETED
A Study of Teriparatide in Japanese Osteoporosis Patients
Lead Sponsor:
Eli Lilly and Company
Conditions:
Osteoporosis
Eligibility:
All Genders
55+ years
Phase:
PHASE4
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-...
Eligibility Criteria
Inclusion
- Ambulatory Japanese males or postmenopausal females with osteoporosis, as determined by the Japanese Society for Bone and Mineral Research (JSBMR) diagnostic criteria
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01430104
Start Date
August 1 2011
End Date
December 1 2011
Last Update
January 14 2013
Active Locations (1)
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1
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