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Bisphosphonate Action on the Appendicular Skeleton: Evidence for Differential Effects

NCT00666627 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 410

Last updated 2018-03-06

No results posted yet for this study

Summary

A study to determine if the three licensed bisphosphonates (alendronate, ibandronate and risedronate):a) affect the peripheral skeleton differently, as assessed by quantitative ultrasound of bone (QUS), peripheral quantitative computed tomography (pQCT) and dual-energy x-ray absorptiometry (DXA)? b) have different effects on bone cells and their activity as assessed by flow cytometry and biochemical markers of bone cell activity? The aim of the study is to compare the effects of three licensed bisphosphonates on bone quantity and quality. There has been no such study before. Most of the measures of bone quantity and quality used in this protocol have not been studied with any of these three agents. The novelty of the study necessitates the establishment of reference ranges and this explains the need for the inclusion of a group of young women.

Conditions

  • Post-menopausal Osteoporosis

Interventions

DRUG

Ibandronate

once monthly

DRUG

Risedronate

Risedronate 35mg once weekly

DRUG

Alendronate

Alendronate 70mg once weekly

Sponsors & Collaborators

  • Procter and Gamble

    collaborator INDUSTRY

  • University of Sheffield

    collaborator OTHER

  • Sheffield Teaching Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Eugene McCloskey, Dr · University of Sheffield

  • Rosemary Hannon, Dr · University of Sheffield

  • Angela Rogers, Dr · University of Sheffield

  • Margaret Paggiosi, Dr · University of Sheffield

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2012-09-30
Completion
2014-12-31

Countries

  • United Kingdom

Study Locations

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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 NCT00666627 on ClinicalTrials.gov