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OsteoporosisPhase 4NCT01430104

A Study of Teriparatide in Japanese Osteoporosis Patients

A Phase 4 study testing Teriparatide, Aspara-CA 600 mg and Alfarol 1.0 µg in people with Osteoporosis, run by Eli Lilly and Company at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Osteoporosis
What is being tested?
Teriparatide, Aspara-CA 600 mg and Alfarol 1.0 µg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteJapan
Study dates
Aug 2011to Dec 2011
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ambulatory Japanese males or postmenopausal females with osteoporosis, as determined by the Japanese Society for Bone and Mineral Research (JSBMR) diagnostic criteria

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • 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

Other trials in Japan

About this study

Official title: A Study to Assess the Effects on Serum Calcium When Teriparatide is Used With Active Vitamin D in Osteoporosis Patients

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.

Conditions
Osteoporosis
Being tested
Teriparatide, Aspara-CA 600 mg, Alfarol 1.0 µg
Medical subject headings
Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TeriparatideDrug

    Also called LY333334, Forteo, Forsteo

    Administered subcutaneously during the Treatment Period

  • Aspara-CA 600 mgDrug

    Administered orally throughout the study

  • Alfarol 1.0 µgDrug

    Administered orally throughout the study

Study groups in NCT01430104
Study groupRoleWhat they receive
Teriparatide + Aspara-CA + AlfarolExperimentalAspara-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.
Receives: Drug: Teriparatide; Drug: Aspara-CA 600 mg; Drug: Alfarol 1.0 µg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 28 (16 and 24 hours postdose)

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

    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.

    Measured: Day 1 up to Day 28 (Teriparatide Treatment Period)

  2. 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).

    Measured: 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)

  3. 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.

    Measured: 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)

  4. 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.

    Measured: Day 1 up to Day 28 (28-day Teriparatide Treatment Period)

  5. Mean Daily Urine Calcium Excreted

    Measured: 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

    Measured: Day 1, Day 7, Day 14, Day 28 (28-day Teriparatide Treatment Period)

  7. Concentrations of Serum 25-Hydroxy-Vitamin D

    Measured: 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

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionDec 2011
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01430104
Sponsor's protocol ID
14454
Other IDs
B3D-JE-GHDT
Status last verified
Nov 2012
First submitted
6 Sep 2011
Last updated
14 Jan 2013
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Teriparatide, Aspara-CA 600 mg and Alfarol 1.0 µg in people with Osteoporosis, run by Eli Lilly and Company at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Serum Calcium Level Over 11.0 Milligrams Per Deciliter (mg/dL) (time frame: Day 28 (16 and 24 hours postdose)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01430104.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2013.

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