A Study of Teriparatide in Japanese Osteoporosis Patients

NCT01430104 | Completed Phase 4 Results

• 2 other identifiers: 14454B3D-JE-GHDT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (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.

  Day 28 (16 and 24 hours postdose)

Secondary Outcomes (8)

• 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

  Day 1 up to Day 28 (Teriparatide Treatment Period)

• Mean Serum Calcium Levels

  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)

• Change From Baseline in Serum Calcium

  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)

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

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

• Mean Daily Urine Calcium Excreted

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

Study Arms (1)

Teriparatide + Aspara-CA + Alfarol

EXPERIMENTAL

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; Drug: Aspara-CA 600 mg; Drug: Alfarol 1.0 µg

Interventions

Teriparatide DRUG

Administered subcutaneously during the Treatment Period

Also known as: LY333334, Forteo, Forsteo

Teriparatide + Aspara-CA + Alfarol

Aspara-CA 600 mg DRUG

Administered orally throughout the study

Teriparatide + Aspara-CA + Alfarol

Alfarol 1.0 µg DRUG

Administered orally throughout the study

Teriparatide + Aspara-CA + Alfarol

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2011
• First Posted: September 7, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 14, 2013
• Results First Posted: December 28, 2012

Record last verified: 2012-11

Locations

JP (1)