A Study of Teriparatide in Japanese Osteoporosis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01430104
First received: September 6, 2011
Last updated: January 7, 2013
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Osteoporosis
Drug: Teriparatide
Drug: Aspara-CA 600 mg
Drug: Alfarol 1.0 µg
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study to Assess the Effects on Serum Calcium When Teriparatide is Used With Active Vitamin D in Osteoporosis Patients

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL) [ Time Frame: Day 28 (16 and 24 hours postdose) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Day 1 up to Day 28 (Teriparatide Treatment Period) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: No ]
  • Change From Baseline in Daily Urine Calcium Excreted [ Time Frame: Day 1, Day 7, Day 14, Day 28 (28-day Teriparatide Treatment Period) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: August 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01430104

Locations
Japan
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.
Tokyo, Japan
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01430104     History of Changes
Other Study ID Numbers: 14454, B3D-JE-GHDT
Study First Received: September 6, 2011
Results First Received: November 27, 2012
Last Updated: January 7, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Teriparatide
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014