Prevalence of osteoporosis in Indian patients undergoing elective arthroplasty and spinal procedures
| ISRCTN | ISRCTN14543098 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14543098 |
| Secondary identifying numbers | ostivia/01 |
- Submission date
- 14/06/2021
- Registration date
- 19/06/2021
- Last edited
- 02/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
The aim of this study is to assess the prevalence of osteoporosis and/or osteopenia in patients undergoing elective arthroplasty and spinal procedures in India. Osteoporosis is a health condition that weakens bones, making them fragile and more likely to break. The stage before osteoporosis is called osteopenia, when bone density is less than normal. Arthroplasty is a surgical procedure to restore the function of a joint.
Who can participate?
Men aged 60 years and over and women aged 55 years and over undergoing arthroplasty or spinal procedures.
What does the study involve?
Patients undergo a bone scan to see if they are osteoporotic or osteopenic. Their fracture risk is assessed using an online questionnaire.
What are the possible benefits and risks of participating?
Checking for osteoporosis in patients undergoing elective arthroplasty and spinal procedures may decrease complications. There is no risk to patients as this is not an interventional study.
Where is the study run from?
Cadila Healthcare (India)
When is the study starting and how long is it expected to run for?
February 2019 to June 2020
Who is funding the study?
Cadila Healthcare (India)
Who is the main contact?
Dr Sujoy Kumar Bhattacharjee
Suyash.Bharat@Zyduscadila.com
Contact information
Public
Sarvodaya Hospital & Research Centre, Sector 8
Faridabad
121006
India
 ORCID ID |
0000-0002-9423-0151 |
|---|---|
| Phone | +91 (0)9999043722 |
| info@drsujoy.com |
Public
Zydus Corporate Park
S G Highway, Near Vaishnodevi Circle
Ahmedabad
382481
India
| ORCID ID |
0000-0002-0743-320X |
|---|---|
| Phone | +91 (0)9760267848 |
| suyash.bharat@zyduscadila.com |
Study information
| Study design | Prospective cross-sectional observational open-label multi-centric study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Epidemiological study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please contact Dr Suyash Bharat (+91 (0)9760267848) for a hard copy |
| Scientific title | A prospective multicenter study on the prevalence of osteoporosis in Indian patients undergoing elective arthroplasty and spinal procedures |
| Study acronym | PROPESI |
| Study hypothesis | To determine the preoperative prevalence of osteoporosis and/or osteopenia in Indian patients undergoing prospective elective arthroplasty/spinal procedures and to evaluate overall bone quality in these patients. |
| Ethics approval(s) | Approved 06/07/2019, Sangini Hospital Ethical Committee (Sangini Hospital, First Floor, Santorini Square, B/h Abhishree Complex, Opp. Star Bazar, Nr. Jodhpur Cross Roads, Satellite, Ahmedabad-380015, Gujarat, India; +91 (0)79 40056171; sanginihospitalec@gmail.com), ref: ECR/147/Inst/GJ/2013/RR-16 |
| Condition | Osteoporosis |
| Intervention | This is a prospective, multicenter, cross-sectional study that will include males (≥60 years) females (≥55 years) undergoing arthroplasty or spinal procedures. Bone mineral density (BMD) at the femoral neck and lumbar spine will be measured by dual-energy X-ray absorptiometry (DEXA). The Fracture Risk Assessment Tool (FRAX®) will be used to evaluate fracture risk. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Bone mineral density measured using DEXA scan in patients undergoing orthopedic procedure at baseline |
| Secondary outcome measures | Fracture risk measure using FRAX score at baseline |
| Overall study start date | 01/02/2019 |
| Overall study end date | 01/06/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 140 |
| Total final enrolment | 127 |
| Participant inclusion criteria | 1. Patients giving informed consent to participate in the study 2. Gender - either male or female 3. Age: male ≥60 years and female ≥55 years 4. Patients who are undergoing elective orthopedic and spinal surgical procedures |
| Participant exclusion criteria | 1. Not willing or not able to sign informed consent 2. Patients who underwent spine surgery in the last 2 years 3. Patients on concomitant chemotherapy drugs |
| Recruitment start date | 31/07/2019 |
| Recruitment end date | 01/06/2020 |
Locations
Countries of recruitment
- India
Study participating centres
Opp Edubridge International School
Grant Road (e)
Mumbai
400004
India
Near Saraswati Shishu Mandir
Lucknow
226020
India
Navranpura
Ahmedabad
380009
India
Faridabad
121006
India
Chandigarh
160022
India
751, Behera Sahi Road
Unit 4, Nayapalli
Bhubaneswar
751012
India
Bengaluru
560052
India
Satyamurthy Nagar
T Nagar
Chennai
600017
India
Shivajinagar
Pune
411016
India
401, CD Barfiwala Road
Andheri West
Mumbai
400049
India
Sponsor information
Industry
Zydus Corporate Park
S G Highway, Near Vaishnodevi Circle
Ahmedabad
382481
India
| Phone | +91 (0)9833868511 |
|---|---|
| Jitesh.Bhattacharya@zyduscadila.com | |
| Website | http://www.zyduscadila.com/ |
"ROR" |
https://ror.org/03ktyvw44 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 21/07/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The researchers intend to publish the epidemiological data. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Suyash Bharat (suyash.bharat@zyduscadila.com). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 10/07/2019 | 08/07/2021 | No | No | |
| Results article | 26/07/2022 | 02/08/2022 | Yes | No |
Additional files
- ISRCTN14543098_PROTOCOL_10Jul19.docx
- Uploaded 08/07/2021
Editorial Notes
02/08/2022: Publication reference added.
11/07/2022: The intention to publish date has been changed from 01/09/2021 to 21/07/2022.
08/07/2021: Uploaded protocol 10 July 2019 (not peer reviewed).
17/06/2021: Trial's existence confirmed by Sangini Hospital Ethical Committee.
