Postmenopausal OsteoporosisNCT01406613
Resolution of Effect of Bisphosphonates on Bone in Postmenopausal Osteoporosis
An observational study of Postmenopausal Osteoporosis, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 87 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- Observation
- How many people
- 86 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2010to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 87 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- female be at least 7 years postmenopausal but less than 87 years of age
- be ambulatory
- be able and willing to participate in the study and provide written informed consent.
- have taken a bisphosphonate for 2 years as a participant in the TRIO study and be compliant > 80%
- have a Bone Mineral Density (BMD) T score > -2.5 at the femoral neck
- be able and willing to participate in the study and provide written informed consent
Show all 9Show fewer
- have previously taken part as premenopausal controls in the TRIO study
- be in good general health as determined by past medical and physical history
- be bisphosphonate naive; premenopausal women.
Who cannot join
- An incident vertebral fracture or more than 5%/year bone loss at the spine or hip during the 2-year TRIO study
- Evidence of a clinically significant organic disease which could prevent the patient from completing the study, including diabetes
- Abuse of alcohol or use of illicit drugs or who consumed more than 4 units of any alcoholic beverage one day prior to the visit (i.e. subjects who might be binge drinkers)
- A history of cancer within the past 5 years excluding skin cancer non melanomas
- A history of ongoing conditions or diseases known to cause abnormalities of calcium metabolism or skeletal health (secondary osteoporosis)
- Chronic renal disease (as defined by a creatinine clearance of ≤ 30ml/min)
Show all 29Show fewer
- Acute or chronic hepatic disease
- Malabsorption syndromes
- Hyperthyroidism as manifested by Thyrotrophin-stimulating hormone (TSH) outside the lower limit of the normal range
- Hyperparathyroidism
- Hypocalcemia or hypercalcemia
- Osteomalacia
- Cushing's syndrome
- Current use of glucocorticoid therapy
- A serum calcium less than 2.2 mmol/l and a Parathyroid hormone (PTH) above 75ng/l
- A history of any known condition that would interfere with the assessment of Dual-emission X-ray absorptiometry (DXA) at either lumbar spine or femoral neck
- Markedly abnormal clinical laboratory parameters that are assessed as clinically significant by the principal investigator
- Require, in the opinion of the consulting physician, continuation of bisphosphonate therapy.
- Are pregnant or nursing (lactating)
- Use of any hormonal forms of contraception/ therapy within the past 2 years that would, in the opinion of the consulting physician, affect bone metabolism.
- Use of anabolic agents such as steroids or PTH, or any bisphosphonate within the past 2 years.
- Have any history of cancer within the past 5 years. Relatively benign skin malignancies, such as basal cell carcinoma or squamous cell carcinoma, are not an exclusion if the patient has been in remission for at least 6 months prior to enrolment.
- Have any chronic disease (HIV or AIDs, clinically significant renal or cardiovascular disease, hyperthyroidism, diabetes, hyperlipidemia) or menstrual cycle irregularity (by history)).
- Have any metabolic bone disease, such as osteoporosis, Paget 's disease, osteogenesis imperfecta, or serious illness affecting normal bone homeostasis (by history and physical exam if required)
- Significant use of any medications known to affect bone metabolism (such as Phenytoin or other anticonvulsants, Selective Estrogen Receptor Modulators (SERMs), heparin or systemic glucocorticosteroids) within the past 2 years.
- Have suffered a fracture within the last 12 months
- Have anorexia nervosa, suspected bulimia (by history or physical) or obvious malnutrition
- Have a history of alcoholism, or who have consumed more than 4 units of any alcoholic beverage one day prior to the visit (i.e., subjects who might be binge drinkers)
- Have previously participated in active therapy clinical trials within the last 3 months
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorks, S5 7AU
About this study
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.
Read more
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).
Read the 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.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- Observation
- Keywords
- Observational, Bone Density, alendronate, ibandronate, risedronate, postmenopausal, osteoporosis
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observation |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startMar 2010
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield
- Responsible party
- Sponsor
- Investigators
- Richard Eastell, Professor, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406613
- Sponsor's protocol ID
- STH15387
- Status last verified
- Feb 2019
- First submitted
- 29 Jul 2011
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01406613
- Acronym / sponsor ID
- STH15387
- Conditions
- Postmenopausal Osteoporosis
- Keywords
- Observational, Bone Density, alendronate, ibandronate, risedronate, postmenopausal, osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Sheffield
- Study start
- Mar 2010 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 1 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Particpants of previous TRIO study | – | Other: ObservationAll 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. |
Who may qualify
- Ages
- Up to 87 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- female be at least 7 years postmenopausal but less than 87 years of age
- be ambulatory
- be able and willing to participate in the study and provide written informed consent.
- have taken a bisphosphonate for 2 years as a participant in the TRIO study and be compliant > 80%
- have a Bone Mineral Density (BMD) T score > -2.5 at the femoral neck
Key exclusion criteria (29 listed)
- An incident vertebral fracture or more than 5%/year bone loss at the spine or hip during the 2-year TRIO study
- Evidence of a clinically significant organic disease which could prevent the patient from completing the study, including diabetes
- Abuse of alcohol or use of illicit drugs or who consumed more than 4 units of any alcoholic beverage one day prior to the visit (i.e. subjects who might be binge drinkers)
- A history of cancer within the past 5 years excluding skin cancer non melanomas
- A history of ongoing conditions or diseases known to cause abnormalities of calcium metabolism or skeletal health (secondary osteoporosis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationIn 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. | Other | Particpants of previous TRIO study |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Eastell, Professor principal investigator
University of Sheffield
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postmenopausal Osteoporosis, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.