Loading clinical trials...

A Study Using Imaging Technology to Measure Changes in Bone Structure After Treatment With Teriparatide | Clinical Trials | Clareo Health

COMPLETEDPHASE4

A Study Using Imaging Technology to Measure Changes in Bone Structure After Treatment With Teriparatide

The Effects of Teriparatide on Bone Microarchitecture as Determined by High Resolution Magnetic Resonance Imaging and Digital Topological Analysis

NCT00557310•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The purpose of this study is to use imaging technologies to demonstrate the effects of teriparatide on bone structure following 18 to 24 months of therapy in postmenopausal women with osteoporosis.

Detailed Description

As teriparatide is approved for up to 24 months of treatment in the US, patients will be given the option to continue in a 6-month extension phase upon completion of 18 months of teriparatide treatment. This extension will allow for collection of additional bone quality data. In Canada, the use of teriparatide is currently approved for 18 months. Patients in Canada may be given the opportunity to participate in the 6-month extension phase, contingent upon Health Canada approval of the use of teriparatide treatment for 24 months.

Eligibility

Age

45 - 85 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•postmenopausal (after the "change of life") women with osteoporosis
•between the ages of 45-85
•have low bone mass as determined by a bone density test
•have at least one prior atraumatic vertebral or nonvertebral fracture(with a T-score of -2.0 or lower at the lumbar spine, total hip, or femoral neck) or, no prior fracture (with a T-score of -3.0 or lower at these same sites)
•could have taken up to 5 years total of certain oral osteoporosis medications such as alendronate, risedronate, or ibandronate

Exclusion Criteria

•have conditions that would affect the bone in the region of the wrist or have had a previous fracture of either wrist which might affect results of study
•have a metal implant or have had a hip replacement in either hip which might affect results of study
•have an increased risk of osteosarcoma; includes Paget's disease of bone, a previous bone tumor, or x-ray treatment to the skeleton
•currently have active or suspected diseases that affect the bone, other than osteoporosis
•have abnormal levels of calcium, parathyroid hormone in blood, or other laboratory values

Locations (6)

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.

Tucson, Arizona, United States

Lakewood, Colorado, United States

Omaha, Nebraska, United States

Albuquerque, New Mexico, United States

Pittsburgh, Pennsylvania, United States

Vancouver, British Columbia, Canada

Key Dates

Start Date

November 1, 2007

Primary Completion Date

October 1, 2010

Completion Date

May 1, 2011

Last Updated

November 11, 2011

Enrollment

ACTUAL participants

Conditions

Osteoporosis, Postmenopausal

Interventions

teriparatide

DRUG

Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)

NCT05575167

Osteoporosis, Postmenopausal

View study

RECRUITINGNA

Vascular Function, Sarcopenia and Pain in Postmenopausal Osteoporosis

NCT05228262

Osteoporosis, Postmenopausal

View study

WITHDRAWNPHASE4

Effect of Mechanical Loading With PTH on Cortical Bone

NCT03232476

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 11, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study Using Imaging Technology to Measure Changes in Bone Structure After Treatment With Teriparatide

Inclusion Criteria

Exclusion Criteria

Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)

Vascular Function, Sarcopenia and Pain in Postmenopausal Osteoporosis

Effect of Mechanical Loading With PTH on Cortical Bone

A Comparison Study With Alendronate and Raloxifene in Postmenopausal Women With Osteoporosis (0217-189)

A Study to Evaluate Alendronate Sodium /Vitamin D3 Combination Tablets(FOSAMAX PLUS) Versus Calcitriol in the Treatment of Osteoporosis in Postmenopausal Women in China (MK-0217A-264)

Efficacy and Safety of MW031 in PMO Subjects