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

Phase 4

Completed

• Conditions: Osteoporosis, Postmenopausal

• Registration Number: NCT00130403
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

All subjects will be treated with teriparatide (human, recombinant PTH\[1-34\])(human, recombinant PTH\[1-34\]), 20 microgram subcutaneously daily for 12 months. Subjects will consist of 290 postmenopausal women previously treated with either risedronate or alendronate for at least 24 months. An approximately equal number of subjects will have been previously treated with risedronate and alendronate, and the subjects will be balanced with regard to duration of previous treatment.

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2005-08-12
• Study First Submitted QC: 2005-08-12
• Study First Posted: 2005-08-15
• Study Completion: 2007-03
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-10
• Last Update Posted: 2011-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 290

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Compare changes from baseline for subjects previously treated with Risedronate or Alendronate for: Bone quality parameters captured by central quantitative computed tomography (QCT)	after 12 months of treatment
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	at 0.5, 1, 2, 3, 4, 5, 6, & 12 months of treatment
Compare changes from baseline for subjects previously treated with Risedronate or Alendronate for: Lumbar spine & hip BMD measured by DXA	after 6 & 12 months of treatment

Trial Locations

Locations (7)

sanofi-aventis, Australia; 🇦🇺 Cove, New South Wales, Australia

sanofi-aventis, Canada; 🇨🇦 Laval, Quebec, Canada

sanofi-aventis, Belgium; 🇧🇪 Diegem, Belgium

sanofi-aventis, US; 🇺🇸 Bridgewater, New Jersey, United States

sanofi-aventis, Netherlands; 🇳🇱 Gouda, Netherlands

sanofi-aventi, UK; 🇬🇧 Guildford, Surrey, United Kingdom

sanofi-aventis, France; 🇫🇷 Paris, France