Determining Feasibility of a Model of Care for Secondary Fracture Prevention

NCT ID: NCT04931602

Last Updated: 2022-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 172 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2023-07-01

Brief 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. 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.

I. 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

V. 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

Biochemical markers i.e. Serum Ca, PTH, CTX, Albumin, Phosphate, Vitamin D and Bone mineral density Scan

Intervention Type: DIAGNOSTIC_TEST

investigations for secondary causes of osteoporosis

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.

Biochemical markers i.e. Serum Ca, PTH, CTX, Albumin, Phosphate, Vitamin D and Bone mineral density Scan

Intervention Type: DIAGNOSTIC_TEST

investigations for secondary causes of osteoporosis

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

Biochemical markers i.e. Serum Ca, PTH, CTX, Albumin, Phosphate, Vitamin D and Bone mineral density Scan

Intervention Type: DIAGNOSTIC_TEST

investigations for secondary causes of osteoporosis

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

Biochemical markers i.e. Serum Ca, PTH, CTX, Albumin, Phosphate, Vitamin D and Bone mineral density Scan

Intervention Type: DIAGNOSTIC_TEST

investigations for secondary causes of osteoporosis

Interventions

Biochemical markers i.e. Serum Ca, PTH, CTX, Albumin, Phosphate, Vitamin D and Bone mineral density Scan

investigations for secondary causes of osteoporosis

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Patients with high impact hip fracture including after road traffic accident

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aga Khan University

OTHER

Sponsor Role: lead

Responsible Party

Sibtain Ahmed

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aga Khan University

Karachi, Sindh, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Sibtain Ahmed

Role: CONTACT

sibtain.ahmed@aku.edu

+922134861951 ext. 1951

Facility Contacts

Sibtain Ahmed

Role: primary

sibtain.ahmed@aku.edu

02134861951

Other Identifiers

2020-3409-14191

Identifier Type: -

Identifier Source: org_study_id