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Phase 3 Clinical Trial of Teriparatide in Japan

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Teriparatide
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Japanese patients diagnosed with osteoporosis
  • Aged 55 or older
  • Patients who are at high risk for fracture

Exclusion Criteria:

  • History of metabolic bone disorders other than primary osteoporosis
  • History of malignant neoplasm in the 5 years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated.
  • Severe or chronically disabling conditions other than osteoporosis

Sites / Locations

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Teriparatide

Placebo

Arm Description

20 micrograms for 104 weeks

Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks

Outcomes

Primary Outcome Measures

Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4)
Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.

Secondary Outcome Measures

Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4)
Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.
Percent Change in Bone Mineral Density (BMD) at Total Hip
Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.
Percent Change in Bone Mineral Density (BMD) at Femoral Neck
Percent change in bone mineral density at femoral neck from baseline to the last measurement point.
Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP)
Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.
Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP)
Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.
Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX)
Percent change in serum type I collagen crosslinked C-telopeptide (CTX) from baseline to the individual visits and last measurement point.
Vertebral Fractures by Central X-ray Assessment
Number of vertebral fractures observed from Visit 1 (study entry) through Visit 19 (Week 52). All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment. Number of subjects with fractures and number of fractured vertebra(e) were counted.
Fractures by Investigators Assessment
Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment. Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident. Fractures were assessed to be "fragility" if they occurred without trauma.
Back Pain Severity
Severity of back pain at baseline, individual visits and the last measurement point. Back pain was measured on a scale of 1 (none) to 4 (severe).
Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) During Open Label Phases at 76 Weeks and 104 Weeks
Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.
Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) During Open Label Phases at 76 Weeks and 104 Weeks
Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.
Percent Change in Bone Mineral Density (BMD) at Total Hip During Open Label Phases at 76 Weeks and 104 Weeks
Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.
Percent Change in Bone Mineral Density (BMD) at Femoral Neck During Open Label Phases at 76 Weeks and 104 Weeks
Percent change in bone mineral density at femoral neck from baseline to the last measurement point.
Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) During Open Label Phases at 76 Weeks and 104 Weeks
Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.
Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) During Open Label Phases at 76 Weeks and 104 Weeks
Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.
Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) During Open Label Phases at 76 Weeks and 104 Weeks
Percent change in serum type I collagen crosslinked C-telepeptide (CTX) from baseline to the individual visits and last measurement point.
Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks
Number of vertebral fractures observed from Visit 1 (study entry) through 104 weeks. All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment. Number of subjects with fractures and number of fractured vertebra(e) were counted.
Fractures by Investigators Assessment During Entire Study Period of 104 Weeks
Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment. Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident. Fractures were assessed to be "fragility" if they occurred without trauma.
Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks
Severity of back pain at 76 weeks and 104 weeks. Back pain was measured on a scale of 1 (none) to 4 (severe).

Full Information

First Posted
February 7, 2007
Last Updated
September 14, 2010
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00433160
Brief Title
Phase 3 Clinical Trial of Teriparatide in Japan
Official Title
Efficacy and Safety of LY333334 in Japanese Patients With Osteoporosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company

4. Oversight

5. Study Description

Brief Summary
To evaluate the efficacy of teriparatide based on measurements of bone mineral density at lumbar spine

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Teriparatide
Arm Type
Experimental
Arm Description
20 micrograms for 104 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
Intervention Type
Drug
Intervention Name(s)
Teriparatide
Other Intervention Name(s)
LY333334, Forteo, Forsteo
Intervention Description
daily, subcutaneous
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
daily, subcutaneous
Primary Outcome Measure Information:
Title
Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4)
Description
Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.
Time Frame
Baseline to 52 weeks
Secondary Outcome Measure Information:
Title
Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4)
Description
Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.
Time Frame
Baseline to 52 Weeks
Title
Percent Change in Bone Mineral Density (BMD) at Total Hip
Description
Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.
Time Frame
Baseline to 52 Weeks
Title
Percent Change in Bone Mineral Density (BMD) at Femoral Neck
Description
Percent change in bone mineral density at femoral neck from baseline to the last measurement point.
Time Frame
Baseline to 52 Weeks
Title
Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP)
Description
Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.
Time Frame
Baseline to Weeks 4, 12, 24, and 52
Title
Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP)
Description
Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.
Time Frame
Baseline to Weeks 4, 12, 24, 52
Title
Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX)
Description
Percent change in serum type I collagen crosslinked C-telopeptide (CTX) from baseline to the individual visits and last measurement point.
Time Frame
Baseline to Weeks 4, 12, 24, 52
Title
Vertebral Fractures by Central X-ray Assessment
Description
Number of vertebral fractures observed from Visit 1 (study entry) through Visit 19 (Week 52). All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment. Number of subjects with fractures and number of fractured vertebra(e) were counted.
Time Frame
Baseline through 52 weeks
Title
Fractures by Investigators Assessment
Description
Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment. Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident. Fractures were assessed to be "fragility" if they occurred without trauma.
Time Frame
Baseline through 52 Weeks
Title
Back Pain Severity
Description
Severity of back pain at baseline, individual visits and the last measurement point. Back pain was measured on a scale of 1 (none) to 4 (severe).
Time Frame
Baseline, Weeks 12, 24, 36, 52
Title
Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) During Open Label Phases at 76 Weeks and 104 Weeks
Description
Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.
Time Frame
Baseline, 76 Weeks, 104 Weeks
Title
Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) During Open Label Phases at 76 Weeks and 104 Weeks
Description
Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.
Time Frame
Baseline, 76 Weeks, 104 Weeks
Title
Percent Change in Bone Mineral Density (BMD) at Total Hip During Open Label Phases at 76 Weeks and 104 Weeks
Description
Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.
Time Frame
Baseline, 76 Weeks, 104 Weeks
Title
Percent Change in Bone Mineral Density (BMD) at Femoral Neck During Open Label Phases at 76 Weeks and 104 Weeks
Description
Percent change in bone mineral density at femoral neck from baseline to the last measurement point.
Time Frame
Baseline, 76 Weeks, 104 Weeks
Title
Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP) During Open Label Phases at 76 Weeks and 104 Weeks
Description
Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.
Time Frame
Baseline, 76 Weeks, 104 Weeks
Title
Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) During Open Label Phases at 76 Weeks and 104 Weeks
Description
Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.
Time Frame
Baseline, 76 Weeks, 104 Weeks
Title
Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX) During Open Label Phases at 76 Weeks and 104 Weeks
Description
Percent change in serum type I collagen crosslinked C-telepeptide (CTX) from baseline to the individual visits and last measurement point.
Time Frame
Baseline, 76 Weeks, 104 Weeks
Title
Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks
Description
Number of vertebral fractures observed from Visit 1 (study entry) through 104 weeks. All new or worsened vertebral fractures were defined as a deterioration of at least one grade in a semiquantitative score by X-ray assessment. Number of subjects with fractures and number of fractured vertebra(e) were counted.
Time Frame
Baseline through 104 Weeks
Title
Fractures by Investigators Assessment During Entire Study Period of 104 Weeks
Description
Vertebral and nonvertebral fractures assessed by the investigator or subinvestigator after starting the study treatment. Traumatic fractures were those caused by falling from above standing height or a high velocity (car) accident. Fractures were assessed to be "fragility" if they occurred without trauma.
Time Frame
Baseline Through 104 Weeks
Title
Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks
Description
Severity of back pain at 76 weeks and 104 weeks. Back pain was measured on a scale of 1 (none) to 4 (severe).
Time Frame
Baseline, 76 Weeks, 104 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Japanese patients diagnosed with osteoporosis Aged 55 or older Patients who are at high risk for fracture Exclusion Criteria: History of metabolic bone disorders other than primary osteoporosis History of malignant neoplasm in the 5 years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. Severe or chronically disabling conditions other than osteoporosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Aichi
ZIP/Postal Code
454-0933
Country
Japan
Facility Name
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.
City
Fukuoka
ZIP/Postal Code
811-2101
Country
Japan
Facility Name
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.
City
Hokkaido
ZIP/Postal Code
070-0034
Country
Japan
Facility Name
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.
City
Hyogo
ZIP/Postal Code
655-0853
Country
Japan
Facility Name
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.
City
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
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.
City
Kagoshima
ZIP/Postal Code
890-0014
Country
Japan
Facility Name
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.
City
Kanagawa
ZIP/Postal Code
231-0023
Country
Japan
Facility Name
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.
City
Nagano
ZIP/Postal Code
386-0493
Country
Japan
Facility Name
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.
City
Nagasaki
ZIP/Postal Code
854-0083
Country
Japan
Facility Name
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.
City
Oita
ZIP/Postal Code
879-7125
Country
Japan
Facility Name
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.
City
Osaka
ZIP/Postal Code
555-0032
Country
Japan
Facility Name
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.
City
Saitama
ZIP/Postal Code
358-0007
Country
Japan
Facility Name
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.
City
Shimane
ZIP/Postal Code
693-0021
Country
Japan
Facility Name
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.
City
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
Facility Name
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.
City
Tokyo
ZIP/Postal Code
163-0202
Country
Japan
Facility Name
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.
City
Tottori
ZIP/Postal Code
683-0853
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
20580870
Citation
Miyauchi A, Matsumoto T, Sugimoto T, Tsujimoto M, Warner MR, Nakamura T. Effects of teriparatide on bone mineral density and bone turnover markers in Japanese subjects with osteoporosis at high risk of fracture in a 24-month clinical study: 12-month, randomized, placebo-controlled, double-blind and 12-month open-label phases. Bone. 2010 Sep;47(3):493-502. doi: 10.1016/j.bone.2010.05.022. Epub 2010 May 24.
Results Reference
result
PubMed Identifier
26185429
Citation
Yamamoto T, Tsujimoto M, Sowa H. Safety of daily teriparatide treatment: a post hoc analysis of a Phase III study to investigate the possible association of teriparatide treatment with calcium homeostasis in patients with serum procollagen type I N-terminal propeptide elevation. Clin Interv Aging. 2015 Jul 6;10:1101-9. doi: 10.2147/CIA.S83549. eCollection 2015.
Results Reference
derived

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Phase 3 Clinical Trial of Teriparatide in Japan

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