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A Study of Teriparatide in Japanese Osteoporosis Patients

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ClinicalTrials.gov Identifier: NCT01430104
Recruitment Status : Completed
First Posted : September 7, 2011
Results First Posted : December 28, 2012
Last Update Posted : January 14, 2013
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE September 6, 2011
First Posted Date  ICMJE September 7, 2011
Results First Submitted Date  ICMJE November 27, 2012
Results First Posted Date  ICMJE December 28, 2012
Last Update Posted Date January 14, 2013
Study Start Date  ICMJE August 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2012)
Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL) [ Time Frame: Day 28 (16 and 24 hours postdose) ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 6, 2011)
Proportion of participants with serum calcium level over 11.0 mg/dL [ Time Frame: Up to 24 hours post dose at Day 28 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2012)
  • 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 [ Time Frame: Day 1 up to Day 28 (Teriparatide Treatment Period) ]
    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 [ 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) ]
    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 [ 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) ]
    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 [ Time Frame: Day 1 up to Day 28 (28-day Teriparatide Treatment Period) ]
    Urine calcium levels presented are for any day during the 28-day Teriparatide Treatment Period.
  • Mean Daily Urine Calcium Excreted [ Time Frame: Day 1 and Day 7 and Day 14 and Day 28 (28-day Teriparatide Treatment Period) ]
  • Change From Baseline in Daily Urine Calcium Excreted [ Time Frame: Day 1, Day 7, Day 14, Day 28 (28-day Teriparatide Treatment Period) ]
  • 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) ]
  • 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) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2011)
  • 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 ]
  • Mean serum calcium levels [ Time Frame: baseline and Day 1 and Day 7 and Day 14 and Day 28 ]
  • Change From Baseline in Serum Calcium [ Time Frame: baseline , Day 1, Day 7, Day 14, Day 28 ]
  • Proportion of participants with daily urine calcium excreted over 0.3 g/day [ Time Frame: baseline up to Day 28 ]
  • Mean Daily Urine Calcium Excreted [ Time Frame: baseline and Day 1 and Day 7 and Day 14 and Day 28 ]
  • Change From Baseline in Daily Urine Calcium Excreted [ 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Teriparatide in Japanese Osteoporosis Patients
Official Title  ICMJE A Study to Assess the Effects on Serum Calcium When Teriparatide is Used With Active Vitamin D in Osteoporosis Patients
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoporosis
Intervention  ICMJE
  • Drug: Teriparatide
    Administered subcutaneously during the Treatment Period
    Other Names:
    • LY333334
    • Forteo
    • Forsteo
  • Drug: Aspara-CA 600 mg
    Administered orally throughout the study
  • Drug: Alfarol 1.0 µg
    Administered orally throughout the study
Study Arms  ICMJE Experimental: Teriparatide + Aspara-CA + Alfarol
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.
Interventions:
  • Drug: Teriparatide
  • Drug: Aspara-CA 600 mg
  • Drug: Alfarol 1.0 µg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 6, 2011)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01430104
Other Study ID Numbers  ICMJE 14454
B3D-JE-GHDT ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: 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) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP