OsteoporosisNCT04931602
Determining Feasibility of a Model of Care for Secondary Fracture Prevention
An observational study of Osteoporosis, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Osteoporosis is a disorder of low bone mass and micro-architectural deterioration resulting in decreased mechanical strength and increased susceptibility to fractures even after minimal trauma. Read more about this study
- Who is it for?
- Ages 30 to 100 years
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Biochemical markers i.e. Serum Ca, PTH, CTX, Albumin, Phosphate, Vitamin D and Bone mineral density Scan
- How many people
- 172 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2021to 1 Jul 2023
- 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 30 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting with low trauma hip fractures at the out-patients or at emergency department
Who may be able to join
- All women ≥50 years with low trauma hip fracture
- All post-menopausal women ( less than 50 years) with low trauma hip fracture
- Men ≥50 years with low trauma hip fracture
Who cannot join
- Patients with high impact hip fracture including after road traffic accident
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan University
Karachi, Sindh, 74800
Sibtain Ahmed, 02134861951, sibtain.ahmed@aku.edu
About this study
Official title: Determining Feasibility of a Model of Care for Secondary Fracture Prevention for Implementation in Health Care System in Pakistan After Hip Fracture: a Clinical Outcome Study
Osteoporosis is a disorder of low bone mass and micro-architectural deterioration resulting in decreased mechanical strength and increased susceptibility to fractures even after minimal trauma. These 'minimal trauma fractures' (also known as 'osteoporotic', 'low trauma' or 'fragility' fractures) are the hallmark of a chronic and disabling disease that affects both men and women worldwide. On statistical grounds, more than 50 % of postmenopausal women and 30 % of men over the age of 60 years will suffer at least one minimal trauma fracture during their remaining lifetime. Any osteoporotic fracture predisposes to further fractures, significant morbidity and premature death. Thus, following a first minimal trauma fracture both men and women have a two- to threefold increased risk of subsequent fracture.
This study aims to determine feasibility of evaluating different models of care through a structured multidisciplinary path tailored to identify, assess and treat hip fracture patients in an effective timely manner that are at high risk of subsequent fracture (Type A model) and to compare its effectiveness and feasibility with a type B, C \& D model as proposed by Ganda et al at the Aga Khan University, with collaboration of the departments of Orthopaedics, Chemical Pathology, Family Medicine and Internal Medicine.
Read the detailed description
With the severity of implications associated with fragility fractures, prevention of a secondary fracture has become a primary focus from a patient care and societal standpoint worldwide. However, this area has been so far neglected in Pakistan. A fracture requires that two conditions occur simultaneously: week bones and a fall or stress on week bones and a co-management approach is required to address both issues.
The investigators propose to determine feasibility of evaluating different models of care through a structured multidisciplinary path tailored to identify, assess and treat hip fracture patients in an effective timely manner that are at high risk of subsequent fracture (Type A model) and to compare its effectiveness and feasibility with a type B, C \& D model as proposed by Ganda et al. Based on this study the investigators will propose a model of care for SFP for application at national level in private and public sector. The long-term plan is to develop a national fragility fracture network in preventing and managing fragility fractures and to promote research aimed at better treatments of osteoporosis, sarcopenia and fracture in line with global CtA from FFN. This information will also help us in applying clinical practice guidelines for osteoporosis and driving policy change for our country which is currently non-existent and is likely to be a step towards the achievement of Sustainable Development Goals (SDG) (i.e. ensure healthy lives and promote wellbeing for all at all ages) and in line with WHO decade of healthy ageing 2021-23.
Specific Aims:
This study is primarily aimed at comparison of the feasibility and effectiveness of models of care (Type A, B, C \& D) for hip fracture patients. The Specific, Measurable, Achievable, Realistic, and Time-defined (SMART) goals of this project are formulated around the 5IQ approach delineated by the Royal Osteoporosis society based on the following 6 parameters.
- Identification: systematic screening of high-risk individuals
II. Investigation: undertaking of relevant investigations to delineate the cause of low bone mass
III. Information: educating patients on falls prevention and fracture risk
IV. Initiation: provision of pharmacological, lifestyle, dietary, conservative management approach and falls prevention interventions according to the model of care adopted
- Integration: promotion of integration between primary and secondary care
VI. Quality: Ensuring professional development, audit, and peer-review activities
Type A model: Intensive service with all routine interventions:
Participants will be followed-up at bone, endocrine and rheumatology clinic after discharge depending upon availability of the consultant. Multifaceted risk-factor assessment for identifying patients at risk will be conducted including formal future fracture risk assessment/life style/medication review and fall risk assessment.
Comprehensive laboratory designed package including calcium (Ca), albumin (ALB), phosphate (P), bone alkaline phosphatase (BAP), C terminal peptide of type 1 collagen (CTx), vitamin D (25OHD) and intact parathyroid hormone (iPTH) will be performed at first clinic visit for all patients between 6-8 weeks post fracture. Screening for secondary causes of osteoporosis will be conducted for those identified in need. BMD testing as per guidelines for patients with fragility fractures will be conducted at clinic visit and recorded with risk assessment form.
Type B model: All intervention except treatment initiation-the responsibility of participants general practitioner for prevention of secondary fracture Those included in this intervention arm, will be identified and risk assessment will be performed at hospital admission. Recommendations for the treatment will be made to be initiated by the patient's general physician. Participants will be followed at 6 months on telephone, and a questionnaire related to treatment compliance \&/or non-compliance will be filled by the coordinator.
Type C model: Health education only provided at the time of admission with handover to family physician for follow-up. Participants will be given an appointment to follow-up at community health center of Aga Khan University.
Type D model: Health Education provided. There is no physician contact with the participant's general practitioner for prevention of secondary fracture. Education material for the patient have been prepared and will be provided to the participant along with counselling by the nurse at the time of discharge.
- Conditions
- Osteoporosis
- Being tested
- Biochemical markers i.e. Serum Ca, PTH, CTX, Albumin, Phosphate, Vitamin D and Bone mineral density Scan
- Keywords
- Hip fractures, fracture, prevention
- Medical subject headings
- Osteoporosis, Hip Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biochemical markers i.e. Serum Ca, PTH, CTX, Albumin, Phosphate, Vitamin D and Bone mineral density ScanDiagnostic test
investigations for secondary causes of osteoporosis
| Study group | Role | What they receive |
|---|---|---|
| Model A | Patients will be followed-up at bone, endocrine and rheumatology clinic after discharge depending upon availability of the consultant. Multifaceted risk-factor assessment for identifying patients at risk will be conducted including formal future fracture risk assessment/life style/medication review and fall risk assessment.
Comprehensive laboratory designed package including calcium (Ca), albumin (ALB), phosphate (P), bone alkaline phosphatase (BAP), C terminal peptide of type 1 collagen (CTx), vitamin D (25OHD) and intact parathyroid hormone (iPTH) will be performed at first clinic visit for all patients between 6-8 weeks post fracture. Screening for secondary causes of osteoporosis will be conducted for those identified in need. BMD testing as per guidelines for patients with fragility fractures will be conducted at clinic visit and recorded with risk assessment form (12). Receives: Diagnostic Test: Biochemical markers i.e. Serum Ca, PTH, CTX, Albumin, Phosphate, Vitamin D and Bone mineral density Scan | |
| Model B | All routine intervention except treatment initiation-the responsibility of patient's general practitioner for prevention of secondary fracture. Those included in this intervention arm, will be identified and risk assessment will be performed at hospital admission. Recommendations for the treatment will be made to be initiated by the patient's general physician. Patients will be followed at 6 months on telephone, and a questionnaire related to treatment compliance \&/or non-compliance will be filled by the coordinator. Receives: Diagnostic Test: Biochemical markers i.e. Serum Ca, PTH, CTX, Albumin, Phosphate, Vitamin D and Bone mineral density Scan | |
| Model C | Health education only provided at the time of admission with handover to family physician for follow-up. Patients will be given an appointment to follow-up at community health center of Aga Khan University Receives: Diagnostic Test: Biochemical markers i.e. Serum Ca, PTH, CTX, Albumin, Phosphate, Vitamin D and Bone mineral density Scan | |
| Model D | Health Education provided. There is no physician contact with the person's general practitioner for prevention of secondary fracture. Education material for the patient have been prepared and will be provided to patient along with counselling by the nurse at the time of discharge Receives: Diagnostic Test: Biochemical markers i.e. Serum Ca, PTH, CTX, Albumin, Phosphate, Vitamin D and Bone mineral density Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Secondary fracture prevention of hip
Rate of Secondary fracture of hip (occurrence of hip fracture (n) if any during the follow up will be noted)
Measured: 1 year of follow-up
Total Secondary fracture prevention
Rate of total fracture (occurrence of fracture (n), if any, during the follow up will be noted)
Measured: 1 year of follow-up
Secondary outcomes (4)
Effectiveness of the models of care- Follow up plan
On a Likert's scale of 1 to 5, rating will be recorded from the participants for: The plan for follow-up was explained to the participant clearly
Measured: 1 year of follow-up
Effectiveness of the models of care- Care provided post fracture
On a Likert's scale of 1 to 5, rating will be recorded from the participants for: Participant is satisfied with the care provided post fracture.
Measured: 1 year of follow-up
Effectiveness of the models of care- Adequacy of information provided
On a Likert's scale of 1 to 5, rating will be recorded from the participants for: right amount of information was given to the participant for secondary fracture prevention
Measured: 1 year of follow-up
Effectiveness of the models of care- Communication
On a Likert's scale of 1 to 5, rating will be recorded from the participants for: The plan for managements for secondary fracture prevention was communicated adequately
Measured: 1 year of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start1 Jul 2021
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibtain Ahmed, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931602
- Sponsor's protocol ID
- 2020-3409-14191
- Status last verified
- Apr 2022
- First submitted
- 9 Jun 2021
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Feasibility of a Model of Care for Secondary Fracture Prevention for Implementation in Health Care System in Pakistan After Hip Fracture: a Clinical Outcome Study
- ClinicalTrials.gov ID
- NCT04931602
- Acronym / sponsor ID
- 2020-3409-14191
- Conditions
- Osteoporosis
- Keywords
- Hip fractures, fracture, prevention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 18 Jun 2021 (actual)
- 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.
Osteoporosis is a disorder of low bone mass and micro-architectural deterioration resulting in decreased mechanical strength and increased susceptibility to fractures even after minimal trauma. These 'minimal trauma fractures' (also known as 'osteoporotic', 'low trauma' or 'fragility' fractures) are the hallmark of a chronic and disabling disease that affects both men and women worldwide. On statistical grounds, more than 50 % of postmenopausal women and 30 % of men over the age of 60 years will suffer at least one minimal trauma fracture during their remaining lifetime. Any osteoporotic fracture predisposes to further fractures, significant morbidity and premature death. Thus, following a first minimal trauma fracture both men and women have a two- to threefold increased risk of subsequent fracture.
This study aims to determine feasibility of evaluating different models of care through a structured multidisciplinary path tailored to identify, assess and treat hip fracture patients in an effective timely manner that are at high risk of subsequent fracture (Type A model) and to compare its effectiveness and feasibility with a type B, C \& D model as proposed by Ganda et al at the Aga Khan University, with collaboration of the departments of Orthopaedics, Chemical Pathology, Family Medicine and Internal Medicine.
Detailed description
With the severity of implications associated with fragility fractures, prevention of a secondary fracture has become a primary focus from a patient care and societal standpoint worldwide. However, this area has been so far neglected in Pakistan. A fracture requires that two conditions occur simultaneously: week bones and a fall or stress on week bones and a co-management approach is required to address both issues.
The investigators propose to determine feasibility of evaluating different models of care through a structured multidisciplinary path tailored to identify, assess and treat hip fracture patients in an effective timely manner that are at high risk of subsequent fracture (Type A model) and to compare its effectiveness and feasibility with a type B, C \& D model as proposed by Ganda et al. Based on this study the investigators will propose a model of care for SFP for application at national level in private and public sector. The long-term plan is to develop a national fragility fracture network in preventing and managing fragility fractures and to promote research aimed at better treatments of osteoporosis, sarcopenia and fracture in line with global CtA from FFN. This information will also help us in applying clinical practice guidelines for osteoporosis and driving policy change for our country which is currently non-existent and is likely to be a step towards the achievement of Sustainable Development Goals (SDG) (i.e. ensure healthy lives and promote wellbeing for all at all ages) and in line with WHO decade of healthy ageing 2021-23.
Specific Aims:
This study is primarily aimed at comparison of the feasibility and effectiveness of models of care (Type A, B, C \& D) for hip fracture patients. The Specific, Measurable, Achievable, Realistic, and Time-defined (SMART) goals of this project are formulated around the 5IQ approach delineated by the Royal Osteoporosis society based on the following 6 parameters.
- Identification: systematic screening of high-risk individuals
II. Investigation: undertaking of relevant investigations to delineate the cause of low bone mass
III. Information: educating patients on falls prevention and fracture risk
IV. Initiation: provision of pharmacological, lifestyle, dietary, conservative management approach and falls prevention interventions according to the model of care adopted
- Integration: promotion of integration between primary and secondary care
VI. Quality: Ensuring professional development, audit, and peer-review activities
Type A model: Intensive service with all routine interventions:
Participants will be followed-up at bone, endocrine and rheumatology clinic after discharge depending upon availability of the consultant. Multifaceted risk-factor assessment for identifying patients at risk will be conducted including formal future fracture risk assessment/life style/medication review and fall risk assessment.
Comprehensive laboratory designed package including calcium (Ca), albumin (ALB), phosphate (P), bone alkaline phosphatase (BAP), C terminal peptide of type 1 collagen (CTx), vitamin D (25OHD) and intact parathyroid hormone (iPTH) will be performed at first clinic visit for all patients between 6-8 weeks post fracture. Screening for secondary causes of osteoporosis will be conducted for those identified in need. BMD testing as per guidelines for patients with fragility fractures will be conducted at clinic visit and recorded with risk assessment form.
Type B model: All intervention except treatment initiation-the responsibility of participants general practitioner for prevention of secondary fracture Those included in this intervention arm, will be identified and risk assessment will be performed at hospital admission. Recommendations for the treatment will be made to be initiated by the patient's general physician. Participants will be followed at 6 months on telephone, and a questionnaire related to treatment compliance \&/or non-compliance will be filled by the coordinator.
Type C model: Health education only provided at the time of admission with handover to family physician for follow-up. Participants will be given an appointment to follow-up at community health center of Aga Khan University.
Type D model: Health Education provided. There is no physician contact with the participant's general practitioner for prevention of secondary fracture. Education material for the patient have been prepared and will be provided to the participant along with counselling by the nurse at the time of discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Model A | – | Diagnostic Test: Biochemical markers i.e. Serum Ca, PTH, CTX, Albumin, Phosphate, Vitamin D and Bone mineral density ScanPatients will be followed-up at bone, endocrine and rheumatology clinic after discharge depending upon availability of the consultant. Multifaceted risk-factor assessment for identifying patients at risk will be conducted including formal future fracture risk assessment/life style/medication review and fall risk assessment. Comprehensive laboratory designed package including calcium (Ca), albumin (ALB), phosphate (P), bone alkaline phosphatase (BAP), C terminal peptide of type 1 collagen (CTx), vitamin D (25OHD) and intact parathyroid hormone (iPTH) will be performed at first clinic visit for all patients between 6-8 weeks post fracture. Screening for secondary causes of osteoporosis will be conducted for those identified in need. BMD testing as per guidelines for patients with fragility fractures will be conducted at clinic visit and recorded with risk assessment form (12). |
| Model B | – | Diagnostic Test: Biochemical markers i.e. Serum Ca, PTH, CTX, Albumin, Phosphate, Vitamin D and Bone mineral density ScanAll routine intervention except treatment initiation-the responsibility of patient's general practitioner for prevention of secondary fracture. Those included in this intervention arm, will be identified and risk assessment will be performed at hospital admission. Recommendations for the treatment will be made to be initiated by the patient's general physician. Patients will be followed at 6 months on telephone, and a questionnaire related to treatment compliance \&/or non-compliance will be filled by the coordinator. |
| Model C | – | Diagnostic Test: Biochemical markers i.e. Serum Ca, PTH, CTX, Albumin, Phosphate, Vitamin D and Bone mineral density ScanHealth education only provided at the time of admission with handover to family physician for follow-up. Patients will be given an appointment to follow-up at community health center of Aga Khan University |
| Model D | – | Diagnostic Test: Biochemical markers i.e. Serum Ca, PTH, CTX, Albumin, Phosphate, Vitamin D and Bone mineral density ScanHealth Education provided. There is no physician contact with the person's general practitioner for prevention of secondary fracture. Education material for the patient have been prepared and will be provided to patient along with counselling by the nurse at the time of discharge |
Who may qualify
- Ages
- 30 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with low trauma hip fractures at the out-patients or at emergency department
Key inclusion criteria (3 listed)
- All women ≥50 years with low trauma hip fracture
- All post-menopausal women ( less than 50 years) with low trauma hip fracture
- Men ≥50 years with low trauma hip fracture
Key exclusion criteria (1 listed)
- Patients with high impact hip fracture including after road traffic accident
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 |
|---|---|---|
| Biochemical markers i.e. Serum Ca, PTH, CTX, Albumin, Phosphate, Vitamin D and Bone mineral density Scaninvestigations for secondary causes of osteoporosis | Diagnostic test | Model A, Model B, Model C, Model D |
Primary outcome
Secondary fracture prevention of hip
Time frame: 1 year of follow-up
Rate of Secondary fracture of hip (occurrence of hip fracture (n) if any during the follow up will be noted)
Total Secondary fracture prevention
Time frame: 1 year of follow-up
Rate of total fracture (occurrence of fracture (n), if any, during the follow up will be noted)
4 secondary outcomes
Effectiveness of the models of care- Follow up plan
Time frame: 1 year of follow-up
Effectiveness of the models of care- Care provided post fracture
Time frame: 1 year of follow-up
Effectiveness of the models of care- Adequacy of information provided
Time frame: 1 year of follow-up
Effectiveness of the models of care- Communication
Time frame: 1 year of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Osteoporosis
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis
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.
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 Osteoporosis, run by Aga Khan University at 1 site in Pakistan.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Apr 2022. 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sibtain Ahmed (+922134861951 ext. 1951, sibtain.ahmed@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Secondary fracture prevention of hip (time frame: 1 year of follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 19 Apr 2022.