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Trial · Interventional

CompletedPhase 3Results postedRegistry data

A Study for Patients With Osteoporosis

NCTNCT00414973 (opens ClinicalTrials.gov in a new tab)Other id10591Other idB3D-MC-GHDG
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Overview

Status
Completed
Phase
Phase 3
Enrollment
364 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
Dec 2006
Primary completion
Jul 2008
Completion
Jul 2008
First posted
22 Dec 2006 (estimated)
Last update posted
28 Oct 2009 (estimated)
Conditions
Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2006200720082009
  1. Ph 3

    A Study for Patients With Osteoporosis

    NCT00414973

    Dec 2006 to Jul 2008

Registry summary

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

The purpose of this study is to compare the effect of injectable teriparatide to intranasal salmon calcitonin on lumbar spine bone mineral density, in the treatment of Chinese patients with established osteoporosis

Interventions

  • TeriparatideDrug
  • Salmon CalcitoninDrug

Arms2

  • Experimental

    A

  • Active comparator

    B

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Postmenopausal Women

    Time frame · Baseline to 24 weeks

    Registry description

    Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.

Secondary outcomes(5)

  1. Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Postmenopausal Women

    Time frame · Baseline to 24 weeks

    Registry description

    Total hip bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.

  2. Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Postmenopausal Women

    Time frame · Baseline to 12 weeks and 24 weeks

    Registry description

    Measures of serum osteocalcin (nanograms per milliliter). Change = Endpoint minus baseline.

  3. Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Men

    Time frame · Baseline to 24 weeks

    Registry description

    Lumbar spine bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.

  4. Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Men

    Time frame · Baseline to 24 weeks

    Registry description

    Total hip bone mineral density (milligrams per square centimeter) was measured by dual energy X-ray absorptiometry (DXA). Change = Endpoint minus baseline.

  5. Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Men

    Time frame · Baseline to 12 weeks and 24 weeks

    Registry description

    Measures of serum osteocalcin (nanograms per milliliter). Change = Endpoint minus baseline.

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 outcomeLeast squares mean· Baseline to 24 weeks

Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Postmenopausal Women

GroupValue (percentage change in lumbar spine BMD)Spread
Teriparatide - Females6.040.48
Calcitonin - Females1.650.65
Secondary and other outcome results(5)
Secondary outcomeLeast squares mean· Baseline to 24 weeks

Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Postmenopausal Women

GroupValue (percentage change in total hip BMD)Spread
Teriparatide - Females-0.530.44
Calcitonin - Females-0.620.59
Secondary outcomeMedian· Baseline to 12 weeks and 24 weeks

Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Postmenopausal Women

GroupValue (percentage change in osteocalcin)Spread
Teriparatide - Females113.8721.46
Calcitonin - Females-7.675.43
Secondary outcomeLeast squares mean· Baseline to 24 weeks

Percentage Change From Baseline to 24 Week Endpoint in Lumbar Spine Bone Mineral Density (BMD), Men

GroupValue (percentage change in lumbar spine BMD)Spread
Teriparatide - Males6.011.20
Calcitonin - Males3.381.77
Secondary outcomeLeast squares mean· Baseline to 24 weeks

Percentage Change From Baseline to 24 Week Endpoint in Total Hip Bone Mineral Density (BMD), Men

GroupValue (percentage change in total hip BMD)Spread
Teriparatide - Males0.371.11
Calcitonin - Males1.341.54
Secondary outcomeMedian· Baseline to 12 weeks and 24 weeks

Percentage Change From Baseline to 12 Weeks and 24 Weeks in Osteocalcin, Men

GroupValue (percentage change in osteocalcin)Spread
Teriparatide - Males107.2714.88
Calcitonin - Males4.3513.48

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Teriparatide - FemalesSubcutaneous, 20 micrograms/day, 24 weeks–8 / ?67 / ?
Calcitonin - FemalesIntranasal, 200 International Units (IU)/day, 24 weeks–1 / ?26 / ?
Teriparatide - MalesSubcutaneous, 20 micrograms/day, 24 weeks–2 / ?7 / ?
Calcitonin - MalesIntranasal, 200 IU/day, 24 weeks–0 / ?0 / ?

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

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 40 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Clinical diagnosis of osteoporosis * No other severe disabling conditions * Should have at least 1 vertebral or non-vertebral prevalent fracture, and bone mineral density T-score should be less than -2.5 * Ambulatory * Men (aged 40 to 85 years) or postmenopausal women (aged 55 to 85 years) Exclusion Criteria: * History of a disease that affects bone metabolism * History of treatment with any drug that may significantly affect bone metabolism * History or presence of liver disease * History or presence of kidney disease * History of excessive alcohol drinking or drug abuse

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