Postmenopausal Osteoporosis Clinical Trial
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
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).
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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