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

Osteoporosis, Postmenopausal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00191425
• Other study ID #: 6537
• Secondary ID: B3D-EW-GHCA
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: July 12, 2007
• Start date: August 2002
• Est. completion date: November 2005

Study information

• Verified date: July 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyBelgium: Federal Agency for Medicines and Health Products, FAMHPDenmark: Danish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Greece: National Organization of MedicinesSpain: Spanish Agency of MedicinesPortugal: National Pharmacy and Medicines InstituteAustria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 810
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

Drug:
• Teriparatide

• Raloxifene

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lumbar spine BMD after 24 months.
Secondary	Hip and femoral neck BMD at 24 months.
Secondary	Comparison of randomized groups, and descriptive analysis of group receiving open-label treatment with teriparatide for 2 years due to prior antiresorptive treatment failure.
Secondary	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.
Secondary	Change in back pain after 1, 6, 12, and 24 mths.
Secondary	Safety of teriparatide.