Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational
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 Secon
Brief Summary:
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