RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
BENGALURU, KARNATAKA
ANNEXURE – II
PROFORMA FOR REGISTRATION OF TOPICS FOR DISSERTATION
1 / Name of the Candidate and Address /DR. RAHUL
POST GRADUATE STUDENT,
DEPARTMENT OF MEDICINE,
COMMAND HOSPITAL,BANGALORE, KARNATAKA.
2 / Name of the Institution / COMMAND HOSPITAL,
BANGALORE, KARNATAKA.
3 / Course of Study and Subject / Post-graduate
M.D. MEDICINE
4 / Date of Admission to Course / 01-05-2012
5 / Title of the Topic / EVALUATION OF BONE HEALTH IN RENAL TRANSPLANT RECIPIENTS
6 / BRIEF RESUME OF THE INTENDED WORK:
6.1 Need for the study:
Osteoporosis occurs commonly in chronic renal disease and contributes to post transplant morbidity by increasing the risk of bone fractures. Little is known about the long term outcome of bone status post renal transplantation in Indian population. Therefore, it is proposed to conduct a cross-sectional evaluation of status of bone health in kidney graft patients.
6.2 Review of Literature
Transplantation is an established therapy for end-stage diseases of the kidney, endocrine pancreas, heart, liver, lung, intestines and for many hematological disorders. Current immunosuppressive regimens with glucocorticoids and calcineurin inhibitors produce excellent patient and graft survival rates. This has resulted in both increases in transplant numbers and an increased recognition of previously neglected long-term complications of transplantation such as fractures and osteoporosis (1).
Exposure to corticosteroids varies with the organ transplanted and the number of rejection episodes. High doses are commonly prescribed immediately after transplantation and are weaned rapidly. Doses are increased at the time of rejection episodes. The highest GC-associated rates of bone loss are in the first 3 to 12 months after transplant. Trabecular sites are predominantly affected (2).
Bone loss in transplant recipients is related both to the underlying diseases and to the immunosuppressive therapy resulting in rapid bone loss and increased fracture rates (3).
Patients are particularly at risk, early after transplantation. The loss may be extensive, at an estimated rate of 6.8% during the first year after transplantation. Severe osteoporosis is very common in the patients on dialysis and kidney transplant recipients compared to the healthy population (8, 9).
The frequency of lumbar spine osteoporosis was 5 times and 4 times higher among the patients on dialysis and kidney transplant recipients than the healthy population, respectively. (4, 11, 12). A10% lower femoral neck BMD (5, 8, 10) and a 9% loss in the vertebral BMD (2) was observed in renal graft patients. BMD reduction after transplantation is highest within the first post transplant year (13).The bone health of candidates for organ transplantation should be assessed with bone densitometry of the hip and spine (14).
Bone density refers to the ratio of weight to the volume or area of the bones. The most common method for measuring bone mass is called Dual Energy X-Ray Absorptiometry, or DEXA scan.
The scores for adults are given as T scores. The T score compares to a healthy 25-year old person of the same sex. A T score of 0 to -1 is considered normal, a T score of -1 to -2.5 is considered osteopenic and less than -2.5 is considered osteoporotic. BMD testing is indicated to monitor patient treatments, or if a patient is being considered for pharmacologic therapy (1)
1. EbelingPR2008 Transplantation osteoporosis. In: Rosen CJ, ed. Primer on the metabolic bone diseases and disorders of mineral metabolism. 7th ed. Chap 61.Washington, DC: American Society for Bone Mineral Research; 279–285.
2. Defranco DJ, Lian JB, Glowacki J 1992 Differential effects of glucocorticoid on recruitment and activity of osteoclasts induced by normal and osteocalcin deficient bone implanted in rats. Endocrinology 131:114–121
3. Lacativa PG, de Mendonca LM, de Mattos Patricio Filho PJ, Pimentel JR, da Cruz Goncalves MD, Fleiuss de Farias ML. Risk factors for decreased total body and regional bone mineral density in hemodialysis patients with severe secondary hyperparathyroidism. J Clin Densitom. 2005;8:352-61..
4. Julian BA, Laskow DA, Dubovsky J, Dubovsky EV, Curtis JJ, Quarles LD. Rapid loss of vertebral mineral density after renal transplantation. N Engl J Med. 1991;325:544-50.
5. Almond MK, Kwan JT, Evans K, Cunningham J. Loss of regional bone mineral density in the first 12 months following renal transplantation. Nephron. 1994;66:527.
6. Grotz WH, Mundinger FA, Rasenack J, et al. Bone loss after kidney transplantation: a longitudinal study in 115 graft recipients. Nephrol Dial Transplant. 1995;10:2096-100.
7. Larijani B, Hossein-Nezhad A, Mojtahedi A, et al. data of bone Mineral Density in healthy Bone Mineral Density and Renal Replacement Therapy—Nouri-Majalan et alIranian Journal of Kidney Diseases | Volume 2 | Number 3 | July 2008 159population of Tehran, Iran: a cross sectional study. BMC Musculoskelet Disord. 2005;6:38.
8. Katz IA, Epstein S. Posttransplantation bone disease. JBone Miner Res. 1992;7:123-6.marrow transplantation.Transplantation. 1990;50:881-3.
9. Ugur A, Guvener N, Isiklar I, Turan M, Erdal R, Haberal M. Osteoporosis after renal transplantation: single center experience. Transplantation. 2001;71:645-9.
10. Katz IA, Epstein S. Posttransplantation bone disease. J Bone Miner Res. 1992;7:123-6.
11. Kelly PJ, Atkinson K, Ward RL, Sambrook PN, Biggs JC, Eisman JA. Reduced bone mineral density in men and women with allogeneic bone marrow transplantation.
12. J Clin Endocrinol Metab 94: 1483–1490, 2009
13. Kanis JA, CC Gluer. An update on the diagnosis and assessment of osteoporosis with densitometry. Committee of Scientific Advisors, International Osteoporosis Foundation. Osteoporos Int. 2000;11(3):192-202.
6.3 Aim of the Study:
To determine the status of bone health in kidney graft patients
6.4 Objective of the Study:
Assessment of bone mineral density in renal transplant recipient using a DEXA HOLOGIC scanner and correlation of same with the dose of immunosuppressive agents used in the treatment especially glucocorticoids(GC) and calcineurin inhibitors.
7. / Materials And Methods
(i) Study Design: Cross sectional study.
(ii) Subjects: Post Renal Transplant patients presenting to Nephrology OPD.
(iii) Inclusion Criteria:
· All consecutive patients of Renal Transplant Recipient presenting to nephrology OPD.
· Willingness to participate in the study
(iv) Exclusion Criteria:
o Patients on estrogen replacement therapy
o Patients with secondary osteoporosis due to-
§ Hyperthyroidism
§ Hypogonadism
§ Hyperprolactinemia
§ Cushing’s syndrome
§ Acromegaly
§ Chronic diarrhea
§ Malabsorption syndrome.
(iii) Sample size: A total of 30 patients will be studied.
(v) Methodology:
Subjects will be enrolled after informed written consent.
BMD of first, second, third and fourth lumbar vertebrae, left femoral neck and left forearm will be assessed using dual-energy x-ray absorptiometry (DEXA-Hologic Discovery Scanner) using standard protocol T and Z score will be noted.
Serum bone alkaline phosphatase, serum creatinine, serum albumin, serum calcium, serum phosphorus, creatinine clearance, 25 (OH) D and intact parathyroid hormone levels will be measured as indices of bone formation and resorption.
Detailed clinical status will be assessed.
Cumulative doses of glucocorticoids and other immunosuppressive drugs will be calculated according to records.
(v) Statistical analysis: Univariate linear regression analysis (Pearson co-relation) will be used to identify factors associated with bone loss. The chi-square test will be used to associate differences in dichotomous variables. Multiple regression analysis will be used to assess the co-relations between age, sex, BMI, time since transplantation, cumulative, immunosuppressant dose, and the spinal and femoral BMDs. Results will be expressed as means +/- standard errors.
Values will be given with 95% confidence intervals.
Parameters will be tested using tests of significance. P- Value of < 0.05 will be taken as significant. SPSS 19 will be used for data analysis.
7.1 Does the Study require any investigations or interventions to be conducted on patients or other humans or animals? If so please describe briefly.
Yes.
Serum bone alkaline phosphatase, serum creatinine, serum albumin, serum calcium, serum phosphorus, creatinine clearance, 25(OH) Vitamin D and intact parathyroid hormone levels of the patient will be assessed. BMD of first, second, third and fourth lumbar vertebrae, left femoral neck and left forearm will be assessed using dual-energy x-ray absorptiometry (DEXA-Hologic Discovery Scanner).
7.2 Has ethical clearance been obtained from your institution in case of 7.1?
Yes.
9. / Signature of the Candidate
10. / Remarks of the Guide
11. / Name & Designation
11.1 Guide
11.2 Signature
11.3 Co-Guide (1)
11.4 Signature
11.5 Co-Guide (2)
11.6 Signature
11.7 Head of the Department
11.8 Signature / BRIG. M S PRAKASH
MD,DM (NEPHROLOGY)
CONSULTANT & HOD,
Department of MEDICINE,
AIR FORCE COMMAND HOSPITAL,
BANGALORE.
LT.COL VIMAL UPRETI
MD, DM (ENDOCRINOLOLOGY)
CLASSIFIED SPECIALIST MEDICINE
& ENDOCRINOLOGY
WG CDR S K PATNAIK
MD (PEDIATRICS)
FELLOWSHIP PEDIA. NEPHROLOGY
CLASSIFIED SPL PEDIATRICS
BRIG M S PRAKASH
MD,DM (NEPHROLOGY)
consultaNT, Nephrology
hod, Department of MEDICINE
air force command hospital
12 / 12.1 Remarks of the Principal
12.2 Signature
CERTIFICATE OF ACCEPTANCE BY THE GUIDE
1. I, BRIG M. S. PRAKASH, hereby accept DR. RAHUL as a candidate of MD (MEDICINE) course. The title of his dissertation is as follows:-
EVALUATION OF BONE HEALTH IN RENAL TRANSPLANT RECIPIENTS
2. He will be under my guidance during the period of his study and thesis work.
DATE BRIGADIER (DR) M. S. PRAKASH
MD (MEDICINE), DM (NEPHROLOGY)
CONSULTANT, NEPHROLOGY
HEAD OF THE DEPARTMENT
DEPARTMENT OF MEDICINE
AIR FORCE COMMAND HOSPITAL
BANGALORE 560007
CERTIFICATE FROM ETHICAL COMMITTEE
1. The committee has examined the scope including the aim, objectives, method of data collection & human/animal intervention of the following study to be carried out by DR. RAHUL under the guidance of BRIGADIER (DR) M S PRAKASH, title of which is
EVALUATION OF BONE HEALTH IN RENAL TRANSPLANT RECIPIENTS
2. The committee has no objection for undertaking this study at COMMAND HOSPITAL (AIR FORCE), BANGALORE, 560007.
(MS PRAKASH) (H SAHNI) (SK JHA)
Brig Gp Capt Col
Prof and HOD OIC AFMRC OIC PG CELL
Dept of Medicine Member Secretary Member
Member
(SC DASH) (S KAISTHA) Mrs VASANTHA KISHORE
Col Wg Cdr Counsellor
Prof and HOD Rep of AFWWA E-Support
Dept of Surgery Member Member
Member Secretory
(S CHAUDHARY) (Dr V SINHA)
Sqn Ldr Physiologist
OIC Legal Cell Scientist ‘D’
Member Member
(MK BEDI)
Air Cmde
AOC MTC
Chairman Ethical Commitee
CERTIFICATE FROM HEAD OF THE INSTITUTION
Permission is hereby accorded to the student Dr RAHUL to undergo MD (MEDICINE) course being conducted at COMMAND HOSPITAL (AIR FORCE) BANGALORE affiliated to RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES commencing from May 2012 under the guidance of BRIG M S PRAKASH, HOD, DEPARTMENT OF MEDICINE, COMMAND HOSPITAL (AIRFORCE) BANGALORE 560007.
(R CHATURVEDI)
Air Cmde
Dean/ Commandant
Command Hospital (Air Force)
BANGALORE-560007
EVALUATION OF BONE HEALTH IN RENAL TRANSPLANT RECIPIENTS
BY
DR RAHUL
SYNOPSIS FOR REGISTRATION OF SUBJECT FOR DISSERTATION
TO
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
KARNATAKA, BANGALORE
IN
PARTIAL FULLFILLMENT OF REGULATIONS FOR AWARD
OF
MASTER DEGREE IN MEDICINE
DEPARTMENT OF MEDICINE
COMMAND HOSPITAL (AIR FORCE) BANGALORE 560007
COMMAND HOSPITAL AIR FORCE BANGALORE
INFORMED CONSENT FORM
I confirm that DR RAHUL has explained to me the purpose of the research, the study procedure (Evaluation of Bone health in Renal Transplant recipients) and I am willing to undergo/enroll my relative, in this study. I understand that I/my relative would require undergoing some blood inv and DEXA scan during review in nephrology OPD.
Alternatives to my participation in the study have also been discussed. I have read and understood this consent form. I agree to give my consent to participate/my relative’s participation as a subject in this study.
This consent has been signed by my own free act of will.
……………………… ………………………… ………….. ………….
Patient Name Patient’s Signature Date Time
I acknowledge the receipt of a copy of this consent form (3 pages)
……………………… ………………………… ………… ….……….
Name of Legally Acceptable LAR’s signature Date Time Representative
I have explained to ………………………………………….. the purpose of this research, the risks and the benefits of this study.
……………………… ………………………… ……… ….……….
Investigator’s Name Investigator’s Signature Date Time
……………………… ………………………… ………….. ….……….
Witness Name Witness Signature Date Time
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