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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191425
First received: September 12, 2005
Last updated: July 12, 2007
Last verified: July 2007
  Purpose

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.


Condition Intervention Phase
Osteoporosis, Postmenopausal
Drug: Teriparatide
Drug: Raloxifene
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Lumbar spine BMD after 24 months.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 810
Study Start Date: August 2002
Estimated Study Completion Date: November 2005
  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.)
  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: NCT00191425

Locations
Germany
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.
Bad Pyrmont, Germany, D-31812
Sponsors and Collaborators
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
  More Information

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00191425     History of Changes
Other Study ID Numbers: 6537, B3D-EW-GHCA
Study First Received: September 12, 2005
Last Updated: July 12, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Greece: National Organization of Medicines
Spain: Spanish Agency of Medicines
Portugal: National Pharmacy and Medicines Institute
Austria: Federal Ministry for Health and Women

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

ClinicalTrials.gov processed this record on October 21, 2014