Resolution of Effect of Bisphosphonates on Bone in Postmenopausal Osteoporosis
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First Received Date ICMJE | July 29, 2011 | ||||
Last Updated Date | June 14, 2012 | ||||
Start Date ICMJE | March 2010 | ||||
Estimated Primary Completion Date | August 2014 (final data collection date for primary outcome measure) | ||||
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Original Primary Outcome Measures ICMJE | |||||
Change History | Complete list of historical versions of study NCT01406613 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Resolution of Effect of Bisphosphonates on Bone in Postmenopausal Osteoporosis | ||||
Official Title ICMJE | 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 | ||||
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 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). |
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Detailed Description | The current study is an observational study aiming to compare the effects of stopping medication on bone quantity and quality, in patients who have previously taken bisphosphonate drugs for a duration of two years. This study will recruit participants who have previously completed the TRIO study. The TRIO study aimed to compare the effects of three licensed bisphosphonates on bone quantity and quality. Participants in the treatment group of the TRIO study were randomised to treatment with one of three licensed bisphosphonates (alendronate, ibandronate and risedronate) for a duration of two years. Measurements taken at the final TRIO study visit will be used as 'baseline' values for this study. The postmenopausal group will have an informed consent visit, followed by further study visits at 24, 48, 72 and 96 weeks after stopping medication. Study visit procedures for the postmenopausal group will include: Blood and urine samples for measurements of bone biomarkers at 24, 48, 72 and 96 weeks off treatment. This study will recruit participants who have previously completed the TRIO study. The TRIO study aimed to compare the effects of three licensed bisphosphonates on bone quantity and quality. Participants in the treatment group of the TRIO study were randomised to treatment with one of three licensed bisphosphonates (alendronate, ibandronate and risedronate) for a duration of two years. Measurements taken at the final TRIO study visit will be used as 'baseline' values for this study. The postmenopausal group will have an informed consent visit, followed by further study visits at 24, 48, 72 and 96 weeks after stopping medication. Study visit procedures for the postmenopausal group will include: Blood and urine samples for measurements of bone biomarkers at 24, 48, 72 and 96 weeks off treatment Height and weight at 48 and 96 weeks off treatment. Bone Mineral Density of the whole body, spine, hip, forearm (DXA) and heel (DXL) at 48 and 96 weeks off treatment Vertebral Fracture Assessment (VFA) at 48 and 96 weeks off treatment. Quantitative Ultrasound of Bone (QUS) of the heel at 48 and 96 weeks off treatment. Participants will be given a diary at their first study visit, to record any newly prescribed medications, hospitalisations, etc. The diary will be reviewed at each study visit to record any adverse events or concomitant medications. Participants will also be asked to complete the standard Metabolic Bone Centre questionnaire at their first and final study visit, so that any changes in lifestyle can be captured. We will maintain the patients on treatment with calcium and vitamin D supplements throughout the study as this would be consistent with standard clinical practice. The TRIO study recruited a group of premenopausal women in order to collect data to act as a reference range for the physical measurements and also to act as internal controls for the study. This study plans to recruit these control participants to continue to act as a reference range in this study. The premenopausal group will have a single study visit, scheduled 96 weeks after completing the TRIO study. Study visit procedures for the premenopausal (reference) group will include: Blood and urine samples for measurements of bone biomarkers Urine based pregnancy test Height and weight Bone Mineral Density of the hip and spine (DXA). A subgroup of 50 premenopausal (reference) women will also have the following: Bone Mineral Density of the whole body, forearm (DXA) and heel (DXL) Quantitative Ultrasound of Bone (QUS) of the heel Participants will be asked to complete the standard Metabolic Bone Centre questionnaire, so that any changes in lifestyle can be captured. Participants will also be asked about any hospitalisations, newly prescribed medications, etc to capture any adverse events and concomitant medications. |
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Study Type ICMJE | Observational | ||||
Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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Biospecimen | Retention: Samples With DNA Description: 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. |
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Sampling Method | Non-Probability Sample | ||||
Study Population | Participants of previous TRIO study - women who either received treatment with alendronate, ibandronate and risedronate for postmenopausal osteoporosis in secondary care. Control premenopausal women will also be recruited. |
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Condition ICMJE | Postmenopausal Osteoporosis | ||||
Intervention ICMJE | Other: Observation
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. |
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Study Group/Cohort (s) | 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.
Intervention: Other: Observation |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Enrolling by invitation | ||||
Estimated Enrollment ICMJE | 200 | ||||
Estimated Completion Date | August 2014 | ||||
Estimated Primary Completion Date | August 2014 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria: Inclusion Criteria for postmenopausal women
Inclusion Criteria for premenopausal women
Exclusion Criteria: Exclusion Criteria for postmenopausal women:
Exclusion Criteria for premenopausal women:
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Gender | Female | ||||
Ages | up to 87 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United Kingdom | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01406613 | ||||
Other Study ID Numbers ICMJE | STH15387 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Sheffield Teaching Hospitals NHS Foundation Trust | ||||
Study Sponsor ICMJE | Sheffield Teaching Hospitals NHS Foundation Trust | ||||
Collaborators ICMJE | Academic Unit of Bone Metabolism | ||||
Investigators ICMJE |
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Information Provided By | Sheffield Teaching Hospitals NHS Foundation Trust | ||||
Verification Date | June 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |