Skip to main content
OpenTrials
Completed

NCT Number: NCT00414973

A Study for Patients With Osteoporosis

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

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., Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Teriparatide

Drug

Subcutaneous, 20 micrograms/day, 24 weeks

Other names: LY333334, Forteo, Forsteo

Salmon Calcitonin

Drug

Intranasal, 200 International Units (IU)/day, 24 weeks

Primary outcomes

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

    Time frame: Baseline to 24 weeks

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

Secondary outcomes

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

    Time frame: Baseline to 24 weeks

    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

    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

    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

    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

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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Comparison of Teriparatide and Calcitonin in the Treatment of Men and Postmenopausal Women With Osteoporosis

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Dec 22, 2006
Registry last updated
Oct 28, 2009

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.