A Study of Teriparatide in Japanese Osteoporosis Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01430104
• Date of registration: 06/09/2011
• Primary sponsor: Eli Lilly and Company
• Public title: A Study of Teriparatide in Japanese Osteoporosis Patients
• Scientific title: A Study to Assess the Effects on Serum Calcium When Teriparatide is Used With Active Vitamin D in Osteoporosis Patients
• Date of first enrolment: August 2011
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01430104
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Japan

Contacts

• Name: 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)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion 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 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



Age minimum: 55 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Osteoporosis

Intervention(s)

Drug: Alfarol 1.0 ug

Drug: Aspara-CA 600 mg

Drug: Teriparatide

Primary Outcome(s)

Proportion of participants with serum calcium level over 11.0 mg/dL [Time Frame: Up to 24 hours post dose at Day 28]

Secondary Outcome(s)

Change from baseline in daily urine calcium excreted [Time Frame: baseline, Day 1, Day 7, Day 14, Day 28]

Change from baseline in serum calcium [Time Frame: baseline , Day 1, Day 7, Day 14, Day 28]

Concentrations of Serum 25-(OH)-vitamin D and 1, 25-(OH)2- vitamin D3 [Time Frame: predose on Day 1 and Day 8 and Day 15 and Day 29]

Mean daily urine calcium excreted [Time Frame: baseline and Day 1 and Day 7 and Day 14 and Day 28]

Mean serum calcium levels [Time Frame: baseline and Day 1 and Day 7 and Day 14 and Day 28]

Proportion of participants with daily urine calcium excreted over 0.3 g/day [Time Frame: baseline up to Day 28]

Proportion of participants with serum calcium level over 11.0 mg/dL and 13.5 mg/dL, respectively [Time Frame: baseline up to Day 28]

Secondary ID(s)

14454

B3D-JE-GHDT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors