Skip to content

Trial · Interventional

CompletedPhase 4Registry data

Combined Administration of Teripapartide and Antiresorptive Agents in Postmenopausal Osteoporosis

Short name Confors

NCTNCT01535027 (opens ClinicalTrials.gov in a new tab)Other idVinforce-003
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
125 participants (actual)
Sponsor
Medical University of Vienna · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Austria

Start
Mar 2006
Primary completion
Dec 2012
Completion
Dec 2012
First posted
17 Feb 2012 (estimated)
Last update posted
3 Jan 2013 (estimated)
Conditions
Osteoporosis

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2006200820102012
  1. Ph 4

    Confors

    NCT01535027

    Mar 2006 to Dec 2012

Registry summary

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

Increased bone formation in the absence of accelerated resorption is resulting in a marked anabolic response to teriparatide (TPTD) during the early phase after treatment initiation. Months later, due to coupling mechanism, the sustained increase of bone formation and ongoing anabolic effects are accompanied by significantly increased bone resorption as well. Antiresorptives influence the balance of bone formation and resorption. Therefore the investigators aim is to investigate the effects of the addition of antiresorptives to the second half of TPTD cycle when resorption is already also markedly elevated.

Interventions

  • teriparatideDrug
  • teriparatide and raloxifeneDrug
  • teriparatide and alendronateDrug

Arms3

  • Active comparator

    Teriparatide

    18 months of daily 20 ug sc. teriparatide monotherapy (TPTD)

  • Active comparator

    Teriparatide and Raloxifene

    9 months teriparatide 20 ug/day sc. monotherapy (TPTD) continued by combination therapy of raloxifene 60 mg/day orally(RAL)and TPTD for another 9 months

  • Active comparator

    Teriparatide and Alendronate

    9 months teriparatide monotherapy 20 ug/day sc.(TPTD) continued by combination therapy of alendronate 70 mg/week orally(ALN)and TPTD for another 9 months

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Differences in changes of areal lumbar spine BMD between the three treatment groups

    Time frame · Evaluation after 9, 12 and 18 months of TPTD

    Registry description

    Primary objective To investigate the changes in lumbar spine BMD of patients among the three treatment groups

Secondary outcomes(1)

  1. Differences in changes of BMDs and markers of bone turnover among the three treatment groups after 18 months TPTD treatment

    Time frame · Evaluation after 9, 12 and 18 months of TPTD treatment

    Registry description

    Secondary objectives * Differences in change of biochemical markers of bone turnover (serum CTX and serum PINP) between treatment groups * Differences in change of the additional DXA results in the hip scan (neck, upper neck, nape, Wards, Troch, shaft, total hip \[g/cm²\]) of patients between treatment groups * To investigate the volumetric changes of vertebral and hip BMD by quantitative computertomography of patients between treatment groups * To investigate safety and tolerability of the treatments

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 · 2014

1 result

Overlapping and continued alendronate or raloxifene administration in patients on teriparatide: effects on areal and volumetric bone mineral density--the CONFORS Study.

Muschitz et al. 2014Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Researchcited by 30

PMID 24619763DOI 10.1002/jbmr.2216PUB-24619763

Full text at the publisher1 result
Publisher pageSee results (1)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 55 Years up to 88 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Ambulatory postmenopausal women at least 55 years of age * Patients with "unsatisfactory clinical response to previous antiresorptive therapy" according to the national reimbursement criteria of Austria (either new clinical or radiographic fragility fracture on ≥ 2 years and/or accelerated bone loss of ≥ 3.5%/year on antiresorptive treatment; discontinuation of oral antiresorptive treatment due to side-effects and substantial risk for osteoporotic fracture defined by a T-Score ≤ -2.5 or ≥ 2 clinical risk factors according to the FRAX™-algorithm)and consequently started with teriparatide treatment * Patients treated with teriparatide (20 ug/day) currently and since 9 months for postmenopausal osteoporosis * Lumbar spine, femoral neck, and total hip evaluable by dual energy x ray absorptiometry (DXA) * Normal or clinically non-significant abnormal laboratory values (as defined by the investigator) * Without language barrier, cooperative, expected to return for all follow-up procedures, and who give informed consent before entering the study and after being informed of the medications and procedures to be used in this study Exclusion Criteria: * History of bone metabolic diseases, Paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis, hyperparathyroidism (uncorrected), and intestinal malabsorption * History of malignant neoplasms in the prior 5 years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. If malignant neoplasm was ever diagnosed, patient must presently be free of disease * History of nephrolithiasis or urolithiasis in the prior 2 years. Patients with any documented history of nephro- or uro-lithiasis must have had an appropriate imaging procedure within the prior 6 months, such as, an intravenous pyleogram (IVP), supine radiograph of the kidney ureter bladder, or renal ultrasound, which must document the absence of stones * Abnormal thyroid function at any time in the prior 6 months. Patients with chronic hypothyreosis and adequate substitution therapy are permitted * Active liver disease (liver enzymes more than three times the upper limit of normal) or clinical jaundice * Significantly impaired renal function. This is defined as serum creatinine \>1.8 mg/dL * Treatment with bone active agent other than teriparatide in the prior 9 months

PepBank is a research reference. Talk to a doctor before you use any peptide.