NCT00130403

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
290

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2004

Typical duration for phase_4

Geographic Reach
7 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

January 11, 2011

Status Verified

January 1, 2011

First QC Date

August 12, 2005

Last Update Submit

January 10, 2011

Conditions

Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

  • 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

Interventions

risedronate sodiumDRUG

Eligibility Criteria

Age55 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

sanofi-aventis, US

Bridgewater, New Jersey, 08807, United States

Location

sanofi-aventis, Australia

Cove, New South Wales, Australia

Location

sanofi-aventis, Belgium

Diegem, Belgium

Location

sanofi-aventis, Canada

Laval, Quebec, Canada

Location

sanofi-aventis, France

Paris, France

Location

sanofi-aventis, Netherlands

Gouda, Netherlands

Location

sanofi-aventi, UK

Guildford, Surrey, United Kingdom

Location

Related Publications (1)

  • Miller PD, Delmas PD, Lindsay R, Watts NB, Luckey M, Adachi J, Saag K, Greenspan SL, Seeman E, Boonen S, Meeves S, Lang TF, Bilezikian JP; Open-label Study to Determine How Prior Therapy with Alendronate or Risedronate in Postmenopausal Women with Osteoporosis Influences the Clinical Effectiveness of Teriparatide Investigators. Early responsiveness of women with osteoporosis to teriparatide after therapy with alendronate or risedronate. J Clin Endocrinol Metab. 2008 Oct;93(10):3785-93. doi: 10.1210/jc.2008-0353. Epub 2008 Aug 5.

    PMID: 18682511DERIVED

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Suzanne Meeves, PharmD, MBA

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 12, 2005

First Posted

August 15, 2005

Study Start

March 1, 2004

Study Completion

March 1, 2007

Last Updated

January 11, 2011

Record last verified: 2011-01

Locations

NL(1)GB(1)US(1)AU(1)CA(1)BE(1)FR(1)