Sequential Use of Teriparatide and Raloxifene HCl in the Treatment of Postmenopausal Women With Osteoporosis

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00035256
First received: May 2, 2002
Last updated: May 11, 2007
Last verified: May 2007
  Purpose

The purpose of this study is to determine whether the increase in spine bone mineral density that has been generally observed in previous clinical studies involving the study drug can be maintained or even increased if followed with raloxifene HCl. All qualifying study participants will receive the study drug followed by treatment with raloxifene HCl or placebo. All study participants will receive raloxifene HCl in the third phase of the study.


Condition Intervention Phase
Osteoporosis, Postmenopausal
Drug: teriparatide
Drug: raloxifene HCl
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Sequential Use of Teriparatide and Raloxifene HCl in the Treatment of Postmenopausal Women With Osteoporosis

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • The study is designed to compare the effect of 1 year of raloxifene treatment with the effect of placebo on maintaining teriparatide-induced increases in spine and hip BMD.

Secondary Outcome Measures:
  • An open-label treatment phase will extend the study for 1 year beyond the primary endpoint. During this final year of the study all patients will receive raloxifene.
  • The purpose of lengthening is to assess the differences in response to raloxifene when it is administered immediately following versus 1 year after(with and without a washout period) withdrawal from teriparatide.

Estimated Enrollment: 330
Study Start Date: October 2001
Study Completion Date: July 2005
  Eligibility

Ages Eligible for Study:   55 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be diagnosed with osteoporosis
  • Must be female, age 55 through 80
  • Must be at least 5 years postmenopausal
  • Must be free of other severe or chronically disabling conditions
  • Must be able to properly use injection device.

Exclusion Criteria:

  • Must not have bone diseases other than osteoporosis
  • Must not have history of certain cancers
  • Must not have certain medical diseases (inflammatory bowel disease, malabsorption syndrome, kidney or bladder stones, venous thrombi or emboli, recent vaginal bleeding due to unknown causes)
  • Must not have treatment with particular medications (warfarin, estrogens, androgens, steroids, calcitonins, fluorides, biphosphonates)
  • Must not have known allergy to the study agent or raloxifene HCl
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035256

Locations
United States, Illinois
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Maywood, Illinois, United States
United States, Oregon
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Portland, Oregon, United States
Canada, Ontario
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Kitchener, Ontario, Canada
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
London, Ontario, Canada
Canada, Quebec
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Sainte -Foy, Quebec, Canada
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00035256     History of Changes
Other Study ID Numbers: 5490, B3D-MC-GHBQ
Study First Received: May 2, 2002
Last Updated: May 11, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Teriparatide
Raloxifene
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Selective Estrogen Receptor Modulators

ClinicalTrials.gov processed this record on August 01, 2014