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Completed

NCT Number: NCT01430104

A Study of Teriparatide in Japanese 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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Teriparatide

Drug

Administered subcutaneously during the Treatment Period

Other names: LY333334, Forteo, Forsteo

Aspara-CA 600 mg

Drug

Administered orally throughout the study

Alfarol 1.0 µg

Drug

Administered orally throughout the study

Primary outcomes

  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)

    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

  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)

    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)

    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)

    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)

    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)

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Sep 7, 2011
Registry last updated
Jan 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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