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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • Aga Khan University

    Karachi, Sindh, 74800

    Sibtain Ahmed, 02134861951, sibtain.ahmed@aku.edu

    Recruiting

Other trials in Pakistan

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.

  1. 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

  1. 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 groups in NCT04931602
Study groupRoleWhat they receive
Model APatients 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 BAll 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 CHealth 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 DHealth 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.

  1. 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

  2. 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)
  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted18 Jun 2021
  2. Study start1 Jul 2021
  3. Primary completion1 Jul 2023 (estimated)
  4. Study completion1 Jul 2023 (estimated)

Resources

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)
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

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.

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Clinical Trial NCT04931602 | AzTrials