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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Phase 3 Clinical Trial of Teriparatide in Japan

NCTNCT00433160 (opens ClinicalTrials.gov in a new tab)Other id10494Other idB3D-JE-GHDB
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
207 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Quadruple masking
Countries
1 country

Japan

Start
Jan 2007
Primary completion
Sept 2008
Completion
Sept 2009
First posted
9 Feb 2007 (estimated)
Last update posted
21 Sept 2010 (estimated)
Conditions
Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2007200820092010
  1. Ph 3

    Phase 3 Clinical Trial of Teriparatide in Japan

    NCT00433160

    Jan 2007 to Sept 2009

Registry summary

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

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

Interventions

  • TeriparatideDrug
  • PlaceboDrug

Arms2

  • Experimental

    Teriparatide

    20 micrograms for 104 weeks

  • Placebo comparator

    Placebo

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4)

    Time frame · Baseline to 52 weeks

    Registry description

    Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.

Secondary outcomes(19)

  1. Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4)

    Time frame · Baseline to 52 Weeks

    Registry description

    Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.

  2. Percent Change in Bone Mineral Density (BMD) at Total Hip

    Time frame · Baseline to 52 Weeks

    Registry description

    Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.

  3. Percent Change in Bone Mineral Density (BMD) at Femoral Neck

    Time frame · Baseline to 52 Weeks

    Registry description

    Percent change in bone mineral density at femoral neck from baseline to the last measurement point.

  4. Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP)

    Time frame · Baseline to Weeks 4, 12, 24, and 52

    Registry description

    Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.

  5. Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP)

    Time frame · Baseline to Weeks 4, 12, 24, 52

    Registry description

    Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.

  6. Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX)

    Time frame · Baseline to Weeks 4, 12, 24, 52

    Registry description

    Percent change in serum type I collagen crosslinked C-telopeptide (CTX) from baseline to the individual visits and last measurement point.

  7. Vertebral Fractures by Central X-ray Assessment

    Time frame · Baseline through 52 weeks

    Registry 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.

  8. Fractures by Investigators Assessment

    Time frame · Baseline through 52 Weeks

    Registry 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.

  9. Back Pain Severity

    Time frame · Baseline, Weeks 12, 24, 36, 52

    Registry 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).

  10. Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4) During Open Label Phases at 76 Weeks and 104 Weeks

    Time frame · Baseline, 76 Weeks, 104 Weeks

    Registry description

    Percent change in bone mineral density (BMD) at lumbar spine (L2-L4) from baseline to the last measurement point.

  11. Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4) During Open Label Phases at 76 Weeks and 104 Weeks

    Time frame · Baseline, 76 Weeks, 104 Weeks

    Registry description

    Percent change in bone mineral density at lumbar spine (L1-L4) from baseline to the last measurement point.

  12. Percent Change in Bone Mineral Density (BMD) at Total Hip During Open Label Phases at 76 Weeks and 104 Weeks

    Time frame · Baseline, 76 Weeks, 104 Weeks

    Registry description

    Percent change in bone mineral density (BMD) at total hip from baseline to the last measurement point.

  13. Percent Change in Bone Mineral Density (BMD) at Femoral Neck During Open Label Phases at 76 Weeks and 104 Weeks

    Time frame · Baseline, 76 Weeks, 104 Weeks

    Registry description

    Percent change in bone mineral density at femoral neck from baseline to the last measurement point.

  14. 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

    Time frame · Baseline, 76 Weeks, 104 Weeks

    Registry description

    Percent change in serum procollagen I N-terminal propeptide (PINP) from baseline to the individual visits and last measurement point.

  15. Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP) During Open Label Phases at 76 Weeks and 104 Weeks

    Time frame · Baseline, 76 Weeks, 104 Weeks

    Registry description

    Percent change in serum bone-specific alkaline phosphatase (BAP) from baseline to the individual visits and last measurement point.

  16. 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

    Time frame · Baseline, 76 Weeks, 104 Weeks

    Registry description

    Percent change in serum type I collagen crosslinked C-telepeptide (CTX) from baseline to the individual visits and last measurement point.

  17. Vertebral Fractures by Central X-ray Assessment During Entire Study Period of 104 Weeks

    Time frame · Baseline through 104 Weeks

    Registry 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.

  18. Fractures by Investigators Assessment During Entire Study Period of 104 Weeks

    Time frame · Baseline Through 104 Weeks

    Registry 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.

  19. Back Pain Severity During Open Label Phases at 76 Weeks and 104 Weeks

    Time frame · Baseline, 76 Weeks, 104 Weeks

    Registry description

    Severity of back pain at 76 weeks and 104 weeks. Back pain was measured on a scale of 1 (none) to 4 (severe).

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 outcomeMean· Baseline to 52 weeks

Percent Change in Bone Mineral Density at Lumbar Spine (L2-L4)

GroupValue (percent change in BMD)Spread
Teriparatide9.825.36
Placebo0.044.34
Secondary and other outcome results(7)
Secondary outcomeMean· Baseline to 52 Weeks

Percent Change in Bone Mineral Density (BMD) at Lumbar Spine (L1-L4)

GroupValue (percent change in BMD)Spread
Teriparatide10.235.74
Placebo0.114.42
Secondary outcomeMean· Baseline to 52 Weeks

Percent Change in Bone Mineral Density (BMD) at Total Hip

GroupValue (percent change in BMD)Spread
Teriparatide2.664.22
Placebo-0.223.38
Secondary outcomeMean· Baseline to 52 Weeks

Percent Change in Bone Mineral Density (BMD) at Femoral Neck

GroupValue (percent change in BMD)Spread
Teriparatide2.246.01
Placebo0.463.89
Secondary outcomeMean· Baseline to Weeks 4, 12, 24, and 52

Percent Change in Biochemical Markers of Bone Metabolism - Serum Procollagen I N-terminal Propeptide (PINP)

GroupValue (percent change in PINP)Spread
Teriparatide90.6749.85
Placebo-9.5814.39
Secondary outcomeMean· Baseline to Weeks 4, 12, 24, 52

Percent Change in Biochemical Markers of Bone Metabolism - Serum Bone-specific Alkaline Phosphatase (BAP)

GroupValue (percent change in BAP)Spread
Teriparatide3.7437.86
Placebo-9.6333.62
Secondary outcomeMean· Baseline to Weeks 4, 12, 24, 52

Percent Change in Biochemical Markers of Bone Metabolism - Serum Type I Collagen Crosslinked C-telopeptide (CTX)

GroupValue (percent change in CTX)Spread
Teriparatide2.7840.73
Placebo-2.0528.17
Secondary outcomeNumber· Baseline through 52 weeks

Vertebral Fractures by Central X-ray Assessment

GroupValue (number of fractures)
Teriparatide7
Placebo5

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Teriparatide (During 52 Weeks)20 micrograms for 104 weeks–7 / 136115 / 136
Placebo (During 52 Weeks)Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks–7 / 6759 / 67
Teriparatide (During 76 Weeks)20 micrograms for 104 weeks–10 / 136123 / 136
Placebo (During 76 Weeks)Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks–9 / 6760 / 67
Teriparatide (During 104 Weeks)20 micrograms for 104 weeks–12 / 136125 / 136
Placebo (During 104 Weeks)Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks–13 / 6764 / 67

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

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2015

6 results

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.

Yamamoto et al. 2015Clinical interventions in agingcited by 2

PMID 26185429PMC4500620DOI 10.2147/cia.s83549PUB-26185429

Free to read · publisher termsCC BY-NC6 results
Read at sourceSee results (6)

Indexing hint: Randomized controlled trial · 2010

16 results

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.

Miyauchi et al. 2010Bonecited by 120

PMID 20580870DOI 10.1016/j.bone.2010.05.022PUB-20580870

Full text at the publisher16 results
Publisher pageSee results (16)

Eligibility

Who could join, as posted.

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

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