Resolution of Effect of Bisphosphonates on Bone in Postmenopausal Osteoporosis
|ClinicalTrials.gov Identifier: NCT01406613|
Recruitment Status : Unknown
Verified June 2012 by Sheffield Teaching Hospitals NHS Foundation Trust.
Recruitment status was: Enrolling by invitation
First Posted : August 1, 2011
Last Update Posted : June 15, 2012
This is a 2year observational study that will recruit patients who have previously completed a randomised, open label, parallel, single centre study (TRIO Study) of three bisphosphonates: alendronate, ibandronate and risedronate. These drugs are the most commonly used group of treatments for postmenopausal osteoporosis in the UK. However, the length of time for which these treatments continue to work after they are stopped has not been fully elucidated. Without this information it is unclear as to how long doctors should treat and whether it would be good practice to give drug 'holidays'.
The investigators plan to compare the effects on bone quantity and quality of stopping these licensed bisphosphonates in patients who have taken the medication for a duration of two years. The investigators aim to recruit up to 100 postmenopausal and up to 100 premenopausal (reference range) subjects. Measurements collected at the final visit of the previous study will be used for 'baseline' values for this study.
The postmenopausal group will have an initial study visit to secure informed consent, and then further study visits at 24, 48, 72 and 96 weeks after stopping medication. Visit procedures will include:
Blood and urine samples for measurements of bone biomarkers Bone Mineral Density of the spine, hip, whole body, forearm Dual-emission X-ray absorptiometry (DXA), and heel dual X-ray and Laser (DXL) Quantitative Ultrasound of Bone (QUS) Vertebral Fracture Assessment (VFA).
The premenopausal group will have one study visit, 96 weeks after completing the previous study. Visit procedures will include:
Blood and urine samples for measurements of bone biomarkers Bone Mineral Density of the spine and hip (DXA)
A subgroup of 50 premenopausal women will also have the following measurements:
Bone Mineral Density of the whole body, forearm (DXA), and heel (DXL) Quantitative Ultrasound of Bone (QUS).
|Condition or disease||Intervention/treatment|
|Postmenopausal Osteoporosis||Other: Observation|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||A 2-year Observational Study of Bone Density and Bone Turnover After Prior Treatment With Alendronate, Ibandronate and Risedronate for Postmenopausal Osteoporosis in Secondary Care|
|Study Start Date :||March 2010|
|Estimated Primary Completion Date :||August 2014|
|Estimated Study Completion Date :||August 2014|
Particpants of previous TRIO study
All participants to this study are being observed as a follow up to a previous study which involved 4 arms. All participants to this follow up study will be subject to identical study procedures.
In this study we will examine the changes in bone density by DXA and QUS and bone turnover after stopping Bisphosphonate treatment. As we wish to measure the speed of offset of effects of treatment we have scheduled visits at 24 week intervals in order to fully assess this effect.
A venous blood sample will be collected from each participant at each visit to analyse biochemical bone markers, and basic biochemistry analysis for eligibility screening.
Two urine samples will be collected from each participant at each study visit, one collected on the morning prior to the study visit and a second sample on the morning of the study visit.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01406613
|Sheffield Teaching Hospitals NHS Foundation Trust|
|Sheffield, South Yorks, United Kingdom, S5 7AU|
|Principal Investigator:||Richard Eastell, Professor||University of Sheffield|