Back to resultsA Study of Teriparatide in Japanese Osteoporosis Patients
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Teriparatide
Aspara-CA 600 mg
Alfarol 1.0 µg
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis
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
Sites / Locations
- 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.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Teriparatide + Aspara-CA + Alfarol
Arm Description
Aspara-CA 600 milligrams (mg) and Alfarol 1.0 microgram (µg) administered orally once daily throughout the study. Teriparatide 20 µg administered subcutaneously once daily for 28 days during the Treatment Period.
Outcomes
Primary Outcome Measures
Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL)
Total serum calcium concentration adjusted by serum albumin concentration. Corrected calcium (mg/dL) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter [g/dL]). Postdose refers to after Teriparatide dose.
Secondary Outcome Measures
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
Total serum calcium concentration adjusted by serum albumin concentration. Corrected calcium (mg/dL) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter [g/dL]). Serum calcium levels presented are for any time postdose on any day during the 28-day Teriparatide Treatment Period.
Mean Serum Calcium Levels
Daily profiles of corrected mean serum calcium levels were determined for each participant. Corrected calcium (milligram per deciliter [mg/dL]) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter [g/dL]). The Least Squares (LS) means were adjusted for Day, Timepoint, Day*Timepoint, and random error. At baseline, participants received only Aspara-CA and Alfarol supplements and the timepoints were based on the times before Aspara-CA and Alfarol administration (predose) and after Aspara-CA and Alfarol administration (postdose). During the 28-day Teriparatide Treatment Period, timepoints were based on before Teriparatide administration (predose) and after Teriparatide administration (postdose).
Change From Baseline in Serum Calcium
Corrected calcium (milligram per deciliter [mg/dL]) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter [g/dL]). The Least Squares (LS) means were controlled for Day, Timepoint, Day*Timepoint, and random error. Postdose refers to after Teriparatide dose.
Number of Participants With Daily Urine Calcium Excreted Over 0.3 Grams Per Day (g/Day) at Any Time Postbaseline
Urine calcium levels presented are for any day during the 28-day Teriparatide Treatment Period.
Mean Daily Urine Calcium Excreted
Change From Baseline in Daily Urine Calcium Excreted
Concentrations of Serum 25-Hydroxy-Vitamin D
Concentrations of Serum 1,25-Hydroxy-2-Vitamin D3
Full Information
NCT ID
NCT01430104
First Posted
September 6, 2011
Last Updated
January 7, 2013
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT01430104
Brief Title
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
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Teriparatide + Aspara-CA + Alfarol
Arm Type
Experimental
Arm Description
Aspara-CA 600 milligrams (mg) and Alfarol 1.0 microgram (µg) administered orally once daily throughout the study. Teriparatide 20 µg administered subcutaneously once daily for 28 days during the Treatment Period.
Intervention Type
Drug
Intervention Name(s)
Teriparatide
Other Intervention Name(s)
LY333334, Forteo, Forsteo
Intervention Description
Administered subcutaneously during the Treatment Period
Intervention Type
Drug
Intervention Name(s)
Aspara-CA 600 mg
Intervention Description
Administered orally throughout the study
Intervention Type
Drug
Intervention Name(s)
Alfarol 1.0 µg
Intervention Description
Administered orally throughout the study
Primary Outcome Measure Information:
Title
Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL)
Description
Total serum calcium concentration adjusted by serum albumin concentration. Corrected calcium (mg/dL) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter [g/dL]). Postdose refers to after Teriparatide dose.
Time Frame
Day 28 (16 and 24 hours postdose)
Secondary Outcome Measure Information:
Title
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
Description
Total serum calcium concentration adjusted by serum albumin concentration. Corrected calcium (mg/dL) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter [g/dL]). Serum calcium levels presented are for any time postdose on any day during the 28-day Teriparatide Treatment Period.
Time Frame
Day 1 up to Day 28 (Teriparatide Treatment Period)
Title
Mean Serum Calcium Levels
Description
Daily profiles of corrected mean serum calcium levels were determined for each participant. Corrected calcium (milligram per deciliter [mg/dL]) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter [g/dL]). The Least Squares (LS) means were adjusted for Day, Timepoint, Day*Timepoint, and random error. At baseline, participants received only Aspara-CA and Alfarol supplements and the timepoints were based on the times before Aspara-CA and Alfarol administration (predose) and after Aspara-CA and Alfarol administration (postdose). During the 28-day Teriparatide Treatment Period, timepoints were based on before Teriparatide administration (predose) and after Teriparatide administration (postdose).
Time Frame
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)
Title
Change From Baseline in Serum Calcium
Description
Corrected calcium (milligram per deciliter [mg/dL]) = total serum calcium concentration (mg/dL) + 4.0 - serum albumin concentration (grams per deciliter [g/dL]). The Least Squares (LS) means were controlled for Day, Timepoint, Day*Timepoint, and random error. Postdose refers to after Teriparatide dose.
Time Frame
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)
Title
Number of Participants With Daily Urine Calcium Excreted Over 0.3 Grams Per Day (g/Day) at Any Time Postbaseline
Description
Urine calcium levels presented are for any day during the 28-day Teriparatide Treatment Period.
Time Frame
Day 1 up to Day 28 (28-day Teriparatide Treatment Period)
Title
Mean Daily Urine Calcium Excreted
Time Frame
Day 1 and Day 7 and Day 14 and Day 28 (28-day Teriparatide Treatment Period)
Title
Change From Baseline in Daily Urine Calcium Excreted
Time Frame
Day 1, Day 7, Day 14, Day 28 (28-day Teriparatide Treatment Period)
Title
Concentrations of Serum 25-Hydroxy-Vitamin D
Time Frame
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)
Title
Concentrations of Serum 1,25-Hydroxy-2-Vitamin D3
Time Frame
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Study of Teriparatide in Japanese Osteoporosis Patients
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