A Study of Teriparatide in Japanese Osteoporosis Patients
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Teriparatide; Aspara-CA 600 mg; Alfarol 1.0 µg
Intervention description: Administered subcutaneously during the Treatment Period; Administered orally throughout the study; Administered orally throughout the study
Intervention MeSH terms: Teriparatide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: No

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.
    

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