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Trial · Interventional

CompletedPhase 4Registry data

OPTAMISE: Clinical Effectiveness of Teriparatide After Alendronate or Risedronate Therapy in Osteoporotic Postmenopausal Women

NCTNCT00130403 (opens ClinicalTrials.gov in a new tab)Other idHMR4003B_4034Other idEudraCT # :2004-002317-37

This trial does not test a peptide that PepBank tracks.

  • Names Teriparatide (PTH 1-34), does not test it. It appears in the title.

Overview

Status
Completed
Phase
Phase 4
Enrollment
290 participants (actual)
Sponsor
Sanofi · Industry
Design
Not randomized · Open label (no masking)
Countries
7 countries

United States, Australia, Belgium, Canada, France, Netherlands, United Kingdom

Start
Mar 2004
Primary completion
Not stated
Completion
Mar 2007
First posted
15 Aug 2005 (estimated)
Last update posted
11 Jan 2011 (estimated)
Conditions
Osteoporosis, Postmenopausal

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20042005200620072008
  1. Ph 4

    OPTAMISE: Clinical Effectiveness of Teriparatide After Alendronate or Risedronate Therapy in Osteoporotic Postmenopausal Women

    NCT00130403

    Mar 2004 to Mar 2007

Registry summary

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

To determine how prior therapy with alendronate or risedronate in postmenopausal women with osteoporosis influences the clinical effectiveness of teriparatide; The primary objective of the study is to compare the teriparatide (human, recombinant PTH\[1-34\])-associated change from baseline in a marker of bone formation, N-terminal propeptide of type I collagen (P1NP), between subjects previously treated with risedronate and those previously treated with alendronate.

Interventions

  • risedronate sodiumDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Compare the PTH-associated change from baseline at Month 3 of procollagen peptide P1NP, in subjects previously treated with Risedronate or Alendronate

    Time frame · at Month 3

Secondary outcomes(3)
  1. Compare changes from baseline for subjects previously treated with Risedronate or Alendronate for: P1NP & other biomarkers including bone-specific alkaline phosphatase, osteocalcin, serum CTX, urine NTX

    Time frame · at 0.5, 1, 2, 3, 4, 5, 6, & 12 months of treatment

  2. Compare changes from baseline for subjects previously treated with Risedronate or Alendronate for: Lumbar spine & hip BMD measured by DXA

    Time frame · after 6 & 12 months of treatment

  3. Compare changes from baseline for subjects previously treated with Risedronate or Alendronate for: Bone quality parameters captured by central quantitative computed tomography (QCT)

    Time frame · after 12 months of treatment

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: Clinical trial · 2008

6 results

Early responsiveness of women with osteoporosis to teriparatide after therapy with alendronate or risedronate.

Miller et al. 2008The Journal of clinical endocrinology and metabolismcited by 152

PMID 18682511PMC5399468DOI 10.1210/jc.2008-0353PUB-18682511

Rights unknown6 results

Eligibility

Who could join, as posted.

Sex
Female
Age
from 55 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
ELIGIBILITY CRITERIA include: * Post-menopausal women who have used risedronate or alendronate continuously for at least 24 mos prior to enrollment * Dosing regimens allowable are continuous (ie, uninterrupted) daily or weekly formulations of risedronate (5 mg once daily \[OD\] or 35 or 30 mg once a week \[OAW\]) or alendronate (10 mg OD or 70 mg OAW), for a minimum of 24 months prior to enrollment into study * Lumbar spine or total hip BMD T-score 1ess than or equal to -2.0 and \>/= 1 prevalent osteoporotic fracture, or lumbar spine or total hip BMD T-score less than or equal to -2.5 with or without and \>/= 1 prevalent osteoporotic fracture. The qualifying values must be documented prior to enrollment * Vitamin D (25-hydroxyvitamin D) between 16 ng/ml and 80 ng/ml * Urine NTX \<50 nmol/mmol creatinine (to assure treatment compliance and bone turnover is in the pre-menopausal range) EXCLUSION CRITERIA include: * Impaired renal function, demonstrated by creatinine clearance \< 30 ml/min * Any condition or disease that may interfere with the evaluation of at least 2 lumbar vertebrae (not necessarily contiguous), determined in a screening radiograph by a radiologist at the central facility (eg, confluent aortic calcifications, severe osteoarthritis, spinal fusion, lumbar spine fractures) * Depot injection vitamin D \>10,000 IU in the past 9 months prior to starting the investigational product * Treatment with antiresorptive agents other than risedronate, alendronate, and hormone replacement therapy within the last 36 months before study entry (ie, ibandronate, pamidronate, etidronate, raloxifene, clodronate, or zoledronate) * Use of combination alendronate and risedronate, either simultaneously or sequentially, within 60 months prior to enrollment, or use of any anti-resorptive agent in combination with risedronate or alendronate

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