Determining Feasibility of a Model of Care for Secondary Fracture Prevention

NCT04931602 | Unknown DMC

• 1 other identifier: 2020-3409-14191
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis

Keywords

Hip fractures; fracture; prevention

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  1 year of follow-up

Secondary Outcomes (4)

• Effectiveness of the models of care- Follow up plan

  1 year of follow-up

• Effectiveness of the models of care- Care provided post fracture

  1 year of follow-up

• Effectiveness of the models of care- Adequacy of information provided

  1 year of follow-up

• Effectiveness of the models of care- Communication

  1 year of follow-up

Study Arms (4)

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).

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.

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

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

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

Interventions

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

investigations for secondary causes of osteoporosis

Model A; Model B; Model C; Model D

Eligibility Criteria

• Age: 30 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients presenting with low trauma hip fractures at the out-patients or at emergency department

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

RECRUITING

MeSH Terms

Conditions

Osteoporosis; Hip Fractures; Fractures, Bone

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Femoral Fractures; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Central Study Contacts

Sibtain Ahmed

CONTACT

+922134861951; sibtain.ahmed@aku.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 18, 2021
• Study Start: July 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: April 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)