Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04931602 |
| Other study ID # |
2020-3409-14191 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2021 |
| Est. completion date |
July 1, 2023 |
Study information
| Verified date |
April 2022 |
| Source |
Aga Khan University |
| Contact |
Sibtain Ahmed |
| Phone |
+922134861951 |
| Email |
sibtain.ahmed[@]aku.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
