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| Sponsor: | Sheffield Teaching Hospitals NHS Foundation Trust |
|---|---|
| Collaborators: |
Procter and Gamble University of Sheffield |
| Information provided by: | Sheffield Teaching Hospitals NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT00666627 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Post-menopausal Osteoporosis |
Drug: Ibandronate Drug: Risedronate Drug: Alendronate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A 2-year Randomised Parallel Group Trial of Alendronate, Ibandronate and Risedronate for Postmenopausal Osteoporosis in Secondary Care. |
| Estimated Enrollment: | 410 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Ibandronate
|
Drug: Ibandronate
once monthly
Other Name: Bonviva
|
|
Active Comparator: 2
Risedronate
|
Drug: Risedronate
Risedronate 35mg once weekly
Other Name: Actonel
|
|
Active Comparator: 3
Alendronate 70mg once weekly
|
Drug: Alendronate
Alendronate 70mg once weekly
Other Name: Fosamax
|
|
No Intervention: 4
Young women control group
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 35 Years to 85 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
BMD T-score (at the lumbar spine or total hip) of less than or equal to
Exclusion Criteria:
use any of the following medications within 12 months of starting study drug
Contacts and Locations| United Kingdom | |
| Bone Biomedical Research Unit, Centre for Biomedical Research, Northern General Hospital | |
| Sheffield, South Yorkshire, United Kingdom, S5 7AU | |
| Study Director: | Eugene McCloskey, Dr | University of Sheffield |
| Study Director: | Rosemary Hannon, Dr | University of Sheffield |
| Study Director: | Angela Rogers, Dr | University of Sheffield |
| Study Director: | Margaret Paggiosi, Dr | University of Sheffield |
More Information
| Responsible Party: | Professor Richard Eastell, University of Sheffield |
| ClinicalTrials.gov Identifier: | NCT00666627 History of Changes |
| Other Study ID Numbers: | STH 14463 |
| Study First Received: | April 23, 2008 |
| Last Updated: | May 6, 2011 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Osteoporosis Post-menopausal osteoporosis Bisphosphonates |
Alendronate Ibandronate Risedronate |
|
Osteoporosis Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Risedronic acid Ibandronic acid Diphosphonates Alendronate |
Etidronic Acid Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Therapeutic Uses |