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Trial · Interventional

CompletedPhase 4Results postedRegistry data

A Study of Teriparatide in Japanese Osteoporosis Patients

NCTNCT01430104 (opens ClinicalTrials.gov in a new tab)Other id14454Other idB3D-JE-GHDT
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
30 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Japan

Start
Aug 2011
Primary completion
Dec 2011
Completion
Dec 2011
First posted
7 Sept 2011 (estimated)
Last update posted
14 Jan 2013 (estimated)
Conditions
Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20112012
  1. Ph 4

    A Study of Teriparatide in Japanese Osteoporosis Patients

    NCT01430104

    Aug 2011 to Dec 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TeriparatideDrug
  • Aspara-CA 600 mgDrug
  • Alfarol 1.0 µgDrug

Arms1

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL)

    Time frame · Day 28 (16 and 24 hours postdose)

    Registry 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.

Secondary outcomes(8)

  1. 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)

    Registry 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.

  2. 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)

    Registry 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).

  3. 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)

    Registry 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.

  4. 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)

    Registry description

    Urine calcium levels presented are for any day during the 28-day Teriparatide Treatment Period.

  5. Mean Daily Urine Calcium Excreted

    Time frame · Day 1 and Day 7 and Day 14 and Day 28 (28-day Teriparatide Treatment Period)

  6. Change From Baseline in Daily Urine Calcium Excreted

    Time frame · Day 1, Day 7, Day 14, Day 28 (28-day Teriparatide Treatment Period)

  7. 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)

  8. 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)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Day 28 (16 and 24 hours postdose)

Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL)

GroupValue (participants)Spread
600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide00
Secondary and other outcome results(7)
Secondary outcomeNumber· Day 1 up to Day 28 (Teriparatide Treatment Period)

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

GroupValue (participants)
600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide0
Secondary outcomeLeast squares mean· 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)

Mean Serum Calcium Levels

GroupValue (mg/dL)
600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide9.00
Secondary outcomeLeast squares mean· 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)

Change From Baseline in Serum Calcium

GroupValue (mg/dL)
600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide-0.255
Secondary outcomeNumber· Day 1 up to Day 28 (28-day Teriparatide Treatment Period)

Number of Participants With Daily Urine Calcium Excreted Over 0.3 Grams Per Day (g/Day) at Any Time Postbaseline

GroupValue (participants)
600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide0
Secondary outcomeMean· Day 1 and Day 7 and Day 14 and Day 28 (28-day Teriparatide Treatment Period)

Mean Daily Urine Calcium Excreted

GroupValue (grams per day (g/day))Spread
600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide0.130.05
Secondary outcomeMean· Day 1, Day 7, Day 14, Day 28 (28-day Teriparatide Treatment Period)

Change From Baseline in Daily Urine Calcium Excreted

GroupValue (grams per day (g/day))Spread
600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide0.010.02
Secondary outcomeMean· 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 25-Hydroxy-Vitamin D

GroupValue (nanogram per milliliter (ng/mL))Spread
600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide23.05.4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
600 mg Aspara-CA + 1 µg Alfarol + 20 µg TeriparatideAspara-CA (600 milligrams \[mg\]) and Alfarol (1.0 microgram \[µg\]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period and the 7-day Follow-up Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.–0 / 295 / 29

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 55 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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