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Trial · Interventional

CompletedPhase 4Registry data

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

NCTNCT00191425 (opens ClinicalTrials.gov in a new tab)Other id6537Other idB3D-EW-GHCA

Overview

Status
Completed
Phase
Phase 4
Enrollment
810 participants
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Germany

Start
Aug 2002
Primary completion
Not stated
Completion
Nov 2005
First posted
19 Sept 2005 (estimated)
Last update posted
16 Jul 2007 (estimated)
Conditions
Osteoporosis, Postmenopausal

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20022003200420052006
  1. Ph 4

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

    NCT00191425

    Aug 2002 to Nov 2005

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TeriparatideDrug
  • RaloxifeneDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Lumbar spine BMD after 24 months.

Secondary outcomes(5)
  1. Hip and femoral neck BMD at 24 months.

  2. Comparison of randomized groups, and descriptive analysis of group receiving open-label treatment with teriparatide for 2 years due to prior antiresorptive treatment failure.

  3. 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.

  4. Change in back pain after 1, 6, 12, and 24 mths.

  5. Safety of teriparatide.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2008

7 results

Bone density after teriparatide in patients with or without prior antiresorptive treatment: one-year results from the EUROFORS study.

Minne et al. 2008Current medical research and opinioncited by 25

PMID 18838053DOI 10.1185/03007990802466595PUB-18838053

Full text at the publisher7 results

Eligibility

Who could join, as posted.

Sex
Female
Age
from 55 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.)

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