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Treatment of Bone Disease in Renal Transplant Recipients

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Posttransplantational bone disease is a mul- tifactorial, complex condition, to which both preexisting renal osteodystrophy and factors emerging after renal transplantation contribute significantly. Among the latter the application of glucocorticoids is considered to play an outstanding pathophysiological role. Posttransplantational bone disease potentially never resolves completely. The two central features of this condition are a rapid and accelerated bone loss as well as a significant elevation of the fracture risk. Therefore, prevention and treatment are mandatory. Vitamin D, the active metabolites and the bisphosphonates are currently the most extensively tested agents for the treatment of renal posttransplantational bone disease. However, the most appropriate therapeutic strategies still need to be determined and it is yet unproven that any medical intervention reduces the fracture risk in renal transplant recipients.
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TREATMENT OF BONE DISEASE IN RENAL TRANSPLANT RECIPIENTS
Editorial
Rev Port Nefrol Hipert 2004; 18 (3) : 137-142
Treatment of bone disease in renal transplant
recipients

Vincent M. Brandenburg, Juergen Floege
Department of Nephrology, University Hospital.
Rheinisch-Westfälische Technische Hochschule (RWTH) Aachen, GERMANY.
ABSTRACT
and the bisphosphonates are currently the most
extensively tested agents for the treatment of
Posttransplantational bone disease is a mul-
renal posttransplantational bone disease. How-
tifactorial, complex condition, to which both pre-
ever, the most appropriate therapeutic strate-
existing renal osteodystrophy and factors emer-
gies still need to be determined and it is yet un-
ging after renal transplantation contribute
proven that any medical intervention reduces the
significantly. Among the latter the application of
fracture risk in renal transplant recipients.
glucocorticoids is considered to play an out-
standing pathophysiological role. Posttrans-
Key-words: Alendronate; bone loss; bone mi-
plantational bone disease potentially never re-
neral density; renal transplantation; treatment;
solves completely. The two central features of
vitamin D.
this condition are a rapid and accelerated bone
loss as well as a significant elevation of the frac-
ture risk. Therefore, prevention and treatment
INTRODUCTION
are mandatory. Vitamin D, the active metabolites
Since the disturbances of bone metabolism
after renal transplantation are complex and
multifactorial the commonly used term “post-
transplantational osteoporosis”1 should be re-
Recebido em: 20/07/2004
placed by a more appropriate nomenclature
Aceite em:
29/07/2004
such as posttransplantational bone disease or
Revista Portuguesa de Nefrologia e Hipertensão
137

Vincent M. Brandenburg, Juergen Floege
posttransplantational osteopathy2. The two out-
studies only exceptionally exceeding 100 pa-
standing sequelae of this condition are a rapid
tients, the study duration rarely exceeded 12
and accelerated bone loss as well as a signifi-
months and only bone mineral density develop-
cant elevation in the fracture risk3-6. While the
ment – not fracture incidence – was the primary
former is pronounced during the first year after
endpoint6. Consequently, the following guidelines
transplantation7 and may result in a bone mi-
for medical intervention in posttransplantational
neral density decrease exceeding 10% within 6
bone disease are a mixture of preliminary con-
months6, the latter is a cumulative problem over
clusions from the therapy data presently avai-
years. Steroid application is the most important
lable in renal transplant recipients6, of opinion-
single contributor in the development of pos-
based recommendations10 and very importantly
ttransplantational bone disease3,6,8. Bone di-
of conclusions by analogy derived from our
sease contributes significantly to increased mor-
therapeutic knowledge concerning bone di-
bidity and may even have some impact on
sease in chronic renal insufficiency10, post-
mortality in renal transplant recipients9. There-
menopausal osteoporosis (www.aace.com),
fore, this issue should be a major focus of the
and glucocorticoid-induced osteoporosis
nephrologist’s care for transplant recipients6.
(www.rheumatology.org). No medication has the
The chance of complete reversibility of os-
official approval for posttransplantational bone
seous disturbances in renal allograft recipients
disease (“off-label use”). Summarizing all these
is limited by 1) incomplete restoration of renal
sources the evidence is currently best for the
function or the development of graft failure and
use of vitamin D, the active vitamin D metabo-
2) by the chronic administration of drugs that
lites, and bisphosphonates6. Other substances
interact negatively with bone metabolism (e.g.
hold promise in special situations but data in
immunosuppressants).
renal transplant recipients are not yet available
[e.g. PTH(1-34) to burst the impasse of ady-
namic bone disease or raloxifene to reduce the
THERAPEUTIC OPTIONS IN
extraordinary cardiovascular risk; see the on-
POSTTRANSPLANTATIONAL BONE
going Raloxifene use for the Heart (RUTH) trial].
DISEASE
Compared to the evidence in case of the
VITAMIN D THERAPY
treatment of postmenopausal osteoporosis, for
which several level 1 recommendations from
The K/DOQI 2003 guidelines explicitly re-
large, randomized, placebo-controlled trials are
commend to orient the therapy of posttrans-
available (“American association of clinical
plantational bone disease towards the guide-
endocrinologists: www.aace.com), the evidence
lines for treatment of bone disease in chronic
for any treatment modality for the accelerated
renal insufficiency10.
posttransplantational bone loss is much less
Oral vitamin D plus calcium is effective in
extensive6. The main reasons for this discre-
the reduction of the postmenopausal oste-
pancy is the generally low power of the avail-
oporotic fracture risk11,12 and vitamin D,
able “bone trials” in renal transplant recipients.
calcitriol and alfacalcidiol are evidence-based
The cumulative number of participants reported
recommendations for the prevention and treat-
so far is only approximately 1000 with single
ment of glucocorticoid-induced osteoporosis
138
Revista Portuguesa de Nefrologia e Hipertensão

TREATMENT OF BONE DISEASE IN RENAL TRANSPLANT RECIPIENTS
(www.rheumatology.org). Therefore, vitamin D
above with vitamin D or active metabolites plus
(cholecalciferol or ergocalciferol) is the basis of
calcium except for those with one or more of
treatment for posttransplantational bone disease
the above-listed contraindications. In that case
especially taking into account that many patients
the dosage of vitamin D or its metabolites should
chronically receive glucocorticoids.
be reduced or the application should be
According to the K/DOQI guidelines vitamin
stopped10. The potential benefits of vitamin D
D (800IE per day) plus calcium (1000-1500mg
derivates (doxercalciferol, paricalcitol) in terms
per day) supplementation should be adminis-
of bone strength in renal transplant recipients
tered in patients with chronic kidney disease
are currently undetermined.
(CKD) stage 2 (glomerular filtration rate, GFR >
60 ml/min) and insufficient (16-30 ng/mL) or
deficient (<15 ng/mL) serum calcidiol levels to
BISPHOSPHONATES
prevent and treat hyperparathyroidism. Its ac-
tive metabolites calcitriol (0.25-0.5 µg/day) and
Alendronate is the most extensively investi-
alfacalcidiol (0.25-0.5 µg/day) are preferred in
gated bisphosphonate in posttransplantational
stage 3 (GFR 30-59 ml/min) and stage 4 (15 –
bone disease6. A dosage of 10 mg alendronate
29 ml/min) renal disease10. Prerequisites for the
per day significantly increased the lumbar and
administration of calcitriol and alfacalcidiol are
femoral BMD within 12 months compared to
calcidiol levels > 30 ng/mL and iPTH levels not
baseline (between 3.4% to 8.2% for the lumbar
falling below the individual target range (CKD
spine and 1.6% to 9.3% for the femoral
stage 3: 35-70 pg/mL, CKD stage 4: 70 – 110
neck)15,17,18. In terms of BMD increase alendro-
pg/mL)10. Additional, prerequisites or the admi-
nate was superior to vitamin D or calcitriol15,18,19,
nistration of vitamin D and the active sterols are
while intravenous pamidronate did not result in
the absence of hypercalcemia and a controlled
a significant BMD increase in renal transplant
calcium×phosphate product (corrected total cal-
recipients20-22. Taking into account these data
cium <9.5mg/dL and phosphate < 4.6 mg/dL)10.
and the effectiveness of alendronate in other
Calcitriol and alfacalcidiol have been shown
forms of osteoporosis23-25, it should currently be
to reduce the extent of early posttransplant bone
regarded as the first choice bisphosphonate for
loss at the lumbar spine and femoral neck com-
posttransplantational bone disease. Risedronate
pared to placebo13,14. However, only one very
– the second first-line bisphosphonate for post-
small study (24 renal transplant recipients)15
menopausal osteoporosis – has not yet been
found a significant increase of posttransplant
evaluated in renal transplant recipients.
bone density after 12 months of calcitriol treat-
Several concerns limit the widespread and
ment. Besides the potential increase in the
unreflected use of bisphosphonates in renal
calcium×phosphate product, additional harmfull
transplant recipients. Among these renal toxi-
side-effects of vitamin D treatment (especially
city26-28 and the threat of adynamic bone disease
with active forms) are the deterioration of renal
need to be especially emphasized20. Therefore,
function, the induction of extraosseous calcifi-
alendronate administration should be restricted
cations and the suppression of the bone me-
to transplant recipients with a high fracture risk
tabolism towards adynamic bone disease10,16.
but with stable transplant function (GFR > 50-
All renal transplant recipients should be treated
60 mL/min)27 and without signs of bone metabo-
according to the recommendations mentioned
lism oversuppression6. Intact PTH levels may
Revista Portuguesa de Nefrologia e Hipertensão
139

Vincent M. Brandenburg, Juergen Floege
help to exclude adynamic bone disease in pa-
transplantation. On the other hand some data
tients with CKD10 but in view of its low sensiti-
in long-term renal transplant recipients indicate
vity bone histomorphometry may be required in
that posttransplantational bone loss is possibly
many cases of doubt29. One or several of the
a creeping and chronic condition requiring long-
following criteria define a patient at risk10,27: pa-
term intervention31 that conversely increases the
tients with previous fractures, with very low bone
risk of deleterious side-effects of active therapy
density (T-score <2.0), with combined kidney-
(renal toxicity, extraosseous calcification, ady-
pancreas transplantation, diabetics and post-
namic bone disease etc.).
menopausal women.
The following section presents a summary
In our opinion two other conditions should be
on current treatment recommendations for
added to the list of bisphosphonate indications:
posttransplantational bone disease (modified
First, a pronounced derangement of the cal-
after10,27).
cium×phosphate product caused by vitamin D
treatment. In vivo data show that switching to
- Consequent control of pretransplant bone
bisphosphonates in the latter setting might be
disease; both adynamic bone disease and
helpful in preventing extraosseous calcifica-
overt osteitis fibrosa should be avoided10.
tions30. Second, a rapid and pronounced bone
- Optimize vitamin D status after transplan-
loss early after transplantation requires fast ac-
tation27.
ting and effective medical intervention. In order
- Recommend calcium intake of 1000-1500
to initiate therapy early enough, a DEXA scan
mg/day27, avoid hypercalcemia.
should be performed at six months posttrans-
- Use of bisphosphonates (alendronate) rec-
plant to identify “fast losers”.
ommended for patients at risk10,27: T-score
<2.0, patients with previous osteoporotic
fractures, diabetics, patients after combined
AREAS OF UNCERTAINTY
kidney-pancreas transplantation and post-
menopausal women. We recommend to
Among many open questions regarding the
perform a DEXA at 6 months posttransplant
optimization of posttransplantational bone dis-
in order to identify “fast losers”. Alendronate
ease treatment three issues warrant special
application in patients with a glomerular fil-
attention: First it urgently needs to be proven,
tration rate <50 ml/min (or creatinine >
that any therapy strategy reduces the fracture
160µmol/L) in patients with adynamic bone
risk in these patients – a decisive question in
disease is not recommended.
view of the fact, that the BMD is only a week
- Consider calcitonin, if vitamin D and
predictor of the fracture risk in patients with
bisphosphonates are not appropriate10,27
CKD26. Second, it is currently impossible to es-
(e.g. 200U calcitonin/day).
tablish an active treatment strategy for patients
- Restore normal gonadal10,27 and thyroid
with adynamic bone disease. Third, closely
function if necessary27.
linked to the first two issues is the uncertainty
- Treat uncontrolled persistent hyperpa-
concerning the necessary duration of therapy.
rathyroidism27 but avoid parathyroid gland
Initiation of treatment appears most promising
oversuppression.
at the time when bone mass is reduced most
- Treat persistent severe hypophospha-
rapidly, i.e. within the first 12 months after renal
temia and hypomagnesemia 27.
140
Revista Portuguesa de Nefrologia e Hipertensão

TREATMENT OF BONE DISEASE IN RENAL TRANSPLANT RECIPIENTS
- Use the lowest possible dose of gluco-
8.
HEAF JG. Bone disease after renal transplantation. Trans-
corticoids27.
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- Start exercise program, stop smoking (i.e.
9.
HEAF J, TVEDEGAARD E, KANSTRUP IL, FOGH-ANDERSEN N. Hyper-
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modulate life-style factors)27.
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10. EKNOYAN G, LEVIN A, LEVIN NW. Bone metabolism and disease
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in chronic kidney disease. Am J Kidney Dis 2003; 42(4
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Corresponding author:
12. MARCUS R, WONG M, HEATH H, III, STOCK JL. Antiresorptive
Vincent Matthias Brandenburg, MD
treatment of postmenopausal osteoporosis: comparison
Department of Nephrology (Internal Medicine II)
of study designs and outcomes in large clinical trials with
University Hospital Aachen
fracture as an endpoint. Endocr Rev 2002; 23(1):16-37.
D-52057 Aachen - Germany
13. E
Email: Vincent.Brandenburg@post.rwth-aachen.de
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