Clinical trial NCT01430104: A Study of Teriparatide in Japanese Osteoporosis Patients
Official title: A Study to Assess the Effects on Serum Calcium When Teriparatide is Used With Active Vitamin D in Osteoporosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoporosis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2011-09-07
Enrollment: 30
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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-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

Primary outcomes:
measure: Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL)
timeFrame: Day 28 (16 and 24 hours postdose)
Secondary outcomes:
measure: Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL) and 13.5 mg/dL, Respectively at Any Time Postbaseline
timeFrame: Day 1 up to Day 28 (Teriparatide Treatment Period)
measure: Mean Serum Calcium Levels
timeFrame: Baseline (Day -1 of 14-day Lead-in Period) and Day 1 and Day 7 and Day 14 and Day 28 at 0 hours (h), 2 h, 4 h, 6 h, 16 h, and 24 h postdose (28-day Teriparatide Treatment Period)
measure: Change From Baseline in Serum Calcium
timeFrame: Baseline (Day -1 of the 14-day Lead-in Period), Day 1, Day 7, Day 14, Day 28 at 0 hours (h), 2 h, 4 h, 6 h, 16 h, and 24 h postdose (28-day Teriparatide Treatment Period)
measure: Number of Participants With Daily Urine Calcium Excreted Over 0.3 Grams Per Day (g/Day) at Any Time Postbaseline
timeFrame: Day 1 up to Day 28 (28-day Teriparatide Treatment Period)
measure: Mean Daily Urine Calcium Excreted
timeFrame: Day 1 and Day 7 and Day 14 and Day 28 (28-day Teriparatide Treatment Period)
measure: Change From Baseline in Daily Urine Calcium Excreted
timeFrame: Day 1, Day 7, Day 14, Day 28 (28-day Teriparatide Treatment Period)
measure: Concentrations of Serum 25-Hydroxy-Vitamin D
timeFrame: Day 1 (Predose, 28-day Teriparatide Treatment Period) and Day 8 and Day 15 and Day 29 (Follow-up Period) and Day 35 (Follow-up Period)
measure: Concentrations of Serum 1,25-Hydroxy-2-Vitamin D3
timeFrame: Day 1 (Predose, 28-day Teriparatide Treatment Period) and Day 8 and Day 15 and Day 29 (Follow-up Period) and Day 35 (Follow-up Period)
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
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)
role: STUDY_DIRECTOR
References: