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Clinical Trials/CTRI/2024/03/064702
CTRI/2024/03/064702Not yet recruitingNot Applicable

Assessment of risk of osteoporotic fractures based on fracture risk assessment tool: A cross-sectional study

Rohilkhand medical college and hospital1 site in 1 country170 target enrollmentStarted: April 2, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
170
Locations
1
Primary Endpoint
To determine risk of osteoporotic fractures based on fracture risk assessment tool with and without BMD.

Study Overview

Brief Summary

Osteoporosis is a systemic skeletal disorder which is nicknamed "silent thief" due to the asymptomatic nature of the disorder until it causes an osteoporotic facture 7. Osteoporotic fractures are one of the major causes of death in elderly men and women across the world 7. Fragility fractures associated with osteoporosis are common and cause significant costs, morbidity, and mortality 7. Neck of femur fractures are the major cause of morbidity and mortality, although reliable epidemiological data are lacking hospital data suggest that neck of femur fractures are common in India Calcium and vitamin D nutrition plays an important role in determining bone health. Vitamin D Deficiency (VDD) in adults can precipitate or exacerbate osteopenia and osteoporosis and increase the risk of fractures, but question is how to detect and treat such cases and how to predict cases, for treatment or preventive measures, with good and cost-effective manner, especially in the rural population of country like INDIA where patients cannot afford “DEXA SCANS” for economic and availability reasons. The WHO introduced Fracture Risk Assessment Tool (FRAX) in 2008 for use of estimating the 10-year probability of osteoporotic fractures (neck of femur, spine, distal end radius, forearm) in untreated patients with osteopenia. FRAX calculates fracture probability of individuals from age, body mass index and risk factors comprising prior fragility fracture, parental history of neck of femur fracture, current tobacco smoking, Overuse of long term oral glucocorticoids, rheumatoid arthritis, other causes of secondary osteoporosis, and alcohol consumption with information on BMD 7. Therapeutic interventions are recommended if the 10-year risk of fractures is more than 20% for major osteoporotic fractures (MOF) and more than 3% for neck of femur fractures. The aim of my study is to determine if FRAX calculations with BMD and without BMD would produce comparable predictions for the 10 year probability of osteoporotic fractures. Being a silent disease osteoporosis is affecting millions of population and leading to osteoporotic fractures. As there are very few studies done in the western Uttar Pradesh region, this study will be in novel cause and will be beneficial study in prevention and treatment of population in and around this region.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
40.00 Year(s) to 90.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Age between 40 to 90 years.
  • Both genders included Primary osteoporosis.
  • Patient willing for study.

Exclusion Criteria

  • Patients on anti-resorptive treatment.
  • Bone metastasis and other secondary osteoporosis patients.

Outcomes

Primary Outcomes

To determine risk of osteoporotic fractures based on fracture risk assessment tool with and without BMD.

Time Frame: 1 year

Secondary Outcomes

  • To compare the values & risk of osteoporotic fractures using fracture risk assessment tool with & without bone mineral density.(1 year)

Investigators

Sponsor
Rohilkhand medical college and hospital
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Ishank Singh

Rohilkhand medical college and hospital

Study Sites (1)

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