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

NCT00130403 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2011-01-11

No results posted yet for this study

Summary

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.

Conditions

  • Osteoporosis, Postmenopausal

Interventions

DRUG

risedronate sodium

Sponsors & Collaborators

  • Procter and Gamble

    collaborator INDUSTRY

  • Sanofi

    lead INDUSTRY

Principal Investigators

  • Suzanne Meeves, PharmD, MBA · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Completion
2007-03-31

Countries

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

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00130403 on ClinicalTrials.gov