2-Year Therapy With Teriparatide vs 1-yr Therapy Followed by 1-Year of Raloxifene or Calcium/Vit D in Severe Postmenopausal Osteoporosis

July 12, 2007 updated by: Eli Lilly and Company

Comparison of a 2-Year Therapy of Teriparatide Alone and Its Sequential Use for 1 Year, With or Without Raloxifene HCl, in the Treatment of Severe Postmenopausal Osteoporosis

The primary purpose of the study is to compare 3 different osteoporosis therapies following one year of teriparatide.In the first year,all eligible patients received open-label teriparatide 20 micrograms/day.After 1 year, patients are randomly assigned to one of 3 possible follow-up treatment regimens for the second 12 months: continuation of teriparatide, switch to raloxifene, or no pharmacological treatment(other than the calcium and vitamin D supplements that everyone receives). Patients are stratified into 3 subsets: (a) patients who have never received any anti-osteoporosis treatment before; (b) patients who received prior antiresorptive treatment successfully; (c) patients who failed to respond adequately to prior antiresorptive drugs (such as bisphosphonates or raloxifene) in the past. These latter patients are not randomized at month 12 but will continue treatment with teriparatide 20 micrograms/day throughout the second year.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

810

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Pyrmont, Germany, D-31812
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Ambulatory women greater or equal to 55 years, at least 2 years postmenopausal.
  • Lumbar spine or total hip or femoral neck bone mineral density measurement must be at least 2.5 standard deviations (SD) below the average bone mass for young women (T-score -2.5 or less).
  • Presence of at least one known and documented preexisting clinical fragility fracture, in the past 3 years.

Patients may be included in substudy 2 if they meet any one of the following additional criteria - Patients who have sustained at least one new fragility fracture (vertebral or nonvertebral), despite prescription of antiresorptive therapy* during the 12 months prior to the last new fracture or patients who, after a minimum of two years after initiating antiresorptive therapy*, either have a lumbar spine, femoral neck, or total hip BMD of at least - 3SD below the average bone mass for young women (T-score -3 or less), or who show a decrease of at least 3.5% in BMD at any one of these sites.

*Antiresorptive therapy includes all bisphosphonates, raloxifene, ERT/HRT, calcitonin, and vitamin D metabolites.

Exclusion Criteria:

For substudy 1 patients only:

  • current or history of vaginal bleeding or spotting of unknown cause in the 1 year prior to study start
  • currently suspected or history of venous thrombotic events (VTE), including lower extremity thrombosis, and other major venous thromboses, or high risk of developing VTE as assessment by the investigator.

Treatment with

  • Vitamin D >50,000 IU/week or with any dose of calcitriol or vitamin D analogs or agonists in the 6 months prior to visit 2
  • Fluorides in the 12 months prior to visit 2.
  • Systemic corticosteroids (other than for replacement therapy) in the 1 month prior to visit 2.(Ophthalmic, otic topical, orally inhaled, nasally inhaled, or intra-articular corticosteroid therapy may be used without these restrictions.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Lumbar spine BMD after 24 months.

Secondary Outcome Measures

Outcome Measure
Hip and femoral neck BMD at 24 months.
Comparison of randomized groups, and descriptive analysis of group receiving open-label treatment with teriparatide for 2 years due to prior antiresorptive treatment failure.
Change in itudinal fracture pattern from 3-year pre-study period to end of the study in all patients who receive teriparatide for 2 years.
Change in back pain after 1, 6, 12, and 24 mths.
Safety of teriparatide.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Chair: 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), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Study Completion

November 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

July 16, 2007

Last Update Submitted That Met QC Criteria

July 12, 2007

Last Verified

July 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6537
  • B3D-EW-GHCA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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