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00:00:00
mm good afternoon and thank you very much uh for the invitation yes
00:00:05
i've been asked to cover the topic of uh oh still poses treatment after
00:00:09
at typical thermal fractures and joe was tunic was this so as you imagine
00:00:14
this is not a an easy task and uh i'm going to try to discuss with you uh uh these aspects
00:00:22
so but we are talking of the tool main side effects
00:00:27
of long term a treatment with auntie was up to draw a dessert
00:00:32
uh and i will focus my presentation just owns you was to put it
00:00:36
stating not zoo on courage exacting especially for the joes tunic was this
00:00:41
but i just would like to remind you hear that um the the main risk
00:00:46
factor for a typical humour factor it's long term treatment with auntie was opted works
00:00:51
uh that that that we have is generally patients wheeze eight to ten years of treatment we don't use opted rates
00:00:57
for joe still because these it's not this cell is the duration of the treatment but
00:01:02
it's also the doors and that's why it's mainly observed in the on call logic settings
00:01:08
and it's high and punitive those ease of onto was up to dress with just this means that
00:01:13
in the field of course to produce we we generally see this way of
00:01:17
side effects also in patients receiving longterm treatment was onto was up to rights
00:01:23
i also show you hear some a. p. due to call data to show you that
00:01:28
says these are really rare events globally let's
00:01:32
say one to a one hundred casey sparrow
00:01:36
a one hundred thousand the patients bill you uh in our feet
00:01:42
so no exact as these rare side effect of you in patients
00:01:47
with it's a long term treatment with auntie was up to drugs
00:01:51
this means that he sees patients received longterm
00:01:54
treatments this is probably because they are at high
00:01:58
risk of bone fragility and it's the reason why you continue this treatment for a long time
00:02:03
we may discuss these but that what was of the patients and
00:02:07
we may be concerned with the future we skull fracture of these patients
00:02:14
so how to deal with these questions of course to put this treatment
00:02:17
after these ravens i choose to discuss this point according to three points
00:02:24
the first one is do we have that are on the risk
00:02:28
of fracture after these events because these patients already had long term free
00:02:36
the second point is if we consider was to put
00:02:39
the treatments what are the bottom side effect of this treatment
00:02:43
all the outcome of these cadence i mean on the healing of
00:02:48
a typical somewhat factor or angie and also potentially the risk of recurrence
00:02:54
and just so point is that if we consider treatment do you have it ends
00:02:59
that out drugs will be effective to prevent
00:03:03
future factor in the specific context of patients
00:03:08
i'm not finally the classical patients uh with osteoporosis and naive or any treatment
00:03:14
so i will try to cover with you the data we have on this
00:03:18
and uh i will begin with a typical to moral fractured first
00:03:22
then we will move to are still on the causes of the joe
00:03:25
and i will finish to some specific considerations that may be applied to both of these uh a complication
00:03:33
so let's begin with a typical to mark fletcher and the risk of new fracture
00:03:37
after not to because someone faction and we had the opportunity in geneva to follow
00:03:43
a fifty five of all patients with a typical similar fracture for i mean for the web of sixty eight
00:03:49
and as you can see she at least found that
00:03:52
most and one patients on to sustain a new fragility fracture
00:03:58
within the year after that typically more fracture major loss to critique fracture
00:04:03
and the major each of these patients just ain't two or three fractures
00:04:08
and when you compare the incidence of fracture uh
00:04:12
compared to patients match for h. b. a mac
00:04:16
and to sustain a major or stupid fracture and we should just that we feel will major stupid factor
00:04:22
as a classical risk of imminent reese facto reese factual risk as you know we'll set
00:04:30
uh see now even higher risk of new or still put it fracture
00:04:34
after and the typical from art factor in these patients suggesting that despite receiving
00:04:41
seven eight or ten years up onto was up to browse these patients with
00:04:45
a typical humour factor remain at very high and imminent risk of new fact
00:04:51
and when we looked at the predictors of new for g. t. factor in these patients zoos
00:04:57
made one was the level of b. m. d. and they that that you observed as the time of the
00:05:03
at typical femoral fracture we did not accept any also
00:05:08
a respectable and the interesting observation we had also is that
00:05:14
we had some patients to continue onto resulted but
00:05:17
after the typical remote factor and some who does continue
00:05:21
and the fact that we continue or not to treatment was not associated
00:05:25
with virtual fighter this is just an observation but one point to plug in
00:05:31
the second point is okay that was our high fiscal factor
00:05:34
so should i consider to continue onto that you draw uh
00:05:38
to move to an an oblique a drought and what will be easy effect
00:05:43
on the feeling of that to the consumer factor or the risk of compliment to a typical summer fact
00:05:49
i will just show you some that ah we can discuss on this was when they tend to be correct tied
00:05:55
i just say she is that we have absolutely no that are regarding the nose remark regarding right that's the same
00:06:01
i uh and i just want to mention that regarding well most of them have as its uh the topic now
00:06:07
in the frame and arched studies there was only a few a typical to mark factor and the whole crew
00:06:14
mainly after the one year of treatments uh during the phase of onto was upkeep
00:06:20
so let's begin with this was when it's an she if i we
00:06:23
bought the cases of one of our cases so classical complete at the because
00:06:28
the more factual in two thousand so t. m. in this lady and
00:06:32
she continued bottlenecks and you can see that five years later she has to
00:06:40
she has two incomplete at the because the more factor on the controller tight side
00:06:47
and this is clearly illustrated what what we know is
00:06:51
that i go back to our patients fifty five cases
00:06:55
uh in in geneva and we had thirty five percent of the
00:07:00
these patients who had compliment to al a typical to mark factor
00:07:04
the major we t. was at the same time of the first uh to
00:07:08
because remote factor but some of them developed these fracture later during the for like
00:07:14
and when you look at the predict those to develop called targeted at a typical from artifacts so
00:07:20
what we found is that continuation of onto was up to drugs
00:07:23
after the index at typical for our factor was associated with these weeks
00:07:29
so suggesting that continuing and onto that you brought after on a typical to more fracture
00:07:34
is not a good option and when you look at the values will use all consensus on the topic
00:07:41
there is a consensus to say that for patients with the comfy and
00:07:44
incomplete at typical from our factor this was when it should be discontinued
00:07:50
of course they say that imagine that you have be that i i
00:07:54
typical k-mart fracture that you see where surgically managed always uh nailing militarily
00:08:01
you may say okay now they don't have any reason to develop a
00:08:05
new a typical summer factor i would say at least on the fear
00:08:09
and in this case maybe we may we concede uh this was a
00:08:13
nato the news maybe in case of high risk of bonsai g. t.
00:08:17
i'm not convinced of that and we will discuss this at the end but
00:08:20
keep this in mind and in any case we don't have any data showing
00:08:25
that if we continues reading these contacts we we improve the risk of fracture in these patients
00:08:32
i just want to mention she is that in the cases of at
00:08:36
the because they want factor option when in patients after you know the
00:08:40
mob if you discontinue the nose you might you would have to deal
00:08:43
with the potential rebound of the ball remote leaning and too many disease
00:08:47
and put aside in these cases we may consider short course of peaceful soul mates and to monitor
00:08:54
all the bone was option mark uh to deal with all these aspects now we got a tele apartheid
00:09:03
we know all that patients with a typical to mark
00:09:06
factor at significantly higher risk of the lady heating nonunion
00:09:12
and frequently need secondary surgical procedures compared with patients with typical thermal fracture
00:09:19
so in this context data type that's been used in
00:09:22
mainly case we bought of up to also bachelor studies
00:09:28
we the object is to promote the feeling of the surgery and
00:09:31
of the initial factor uh or if i actually of the incomplete fracture
00:09:35
you have your table some allies in the data out also motion align case report
00:09:42
well radiological feeling of the at the because immoral fracture after to the part that that
00:09:49
and nobody what you see if you look at the rate of healing after six o. moans all one year
00:09:56
you see that yes globally maybe there is a trend
00:10:00
that patients treated with the reaper tied have a small bit
00:10:05
if it's on the healing compared to lose who did not
00:10:08
receive that again this is not randomised control trials uh uh
00:10:14
what actually was more single here but what is interesting for us
00:10:19
it's this case all eight of incomplete active because from what factor
00:10:24
in which you will not decide to do the surgery isn't a lean and
00:10:28
your afraid that they develop a complete fracture uh within the next month so you
00:10:33
and when you look at that the case report looking at that show a very
00:10:38
low weight of healing in this population of incomplete to because remote fractures so globally
00:10:44
the message we have is that yes maybe to repair that might result
00:10:48
in faster healing you of search it surgically treated to because what factor
00:10:54
but there is no evidence for benefits in non surgically
00:10:58
treaty income pick a typical german faction and these observations
00:11:04
ah comfy and in the first double
00:11:07
blind placebo controlled one demise trial who focused
00:11:11
on telly but i'd in incomplete at the because um well fractures this is a ten agenda uh studies that
00:11:18
which is not yet published but the first results of these staff trial
00:11:23
where i presented to usable at i. b. m. yeah and you see that
00:11:27
in these thirty four women who had or incomplete a typical thermal fracture
00:11:34
you all received this forceful mates exposure we use your duration mean duration of ten years
00:11:41
on values outcomes including the war marks call
00:11:46
so i'm past what so what outcomes without being a name the quality of
00:11:51
life some outcomes regarding the b. a. n. d.'s and outcomes regarding the ideological healing
00:11:57
there was absolutely no benefit of the prototype compared to placebo in the study
00:12:03
so consuming that you you don't have evidence that we help patients on this aspect with the report
00:12:09
just one observations in the country in order to study
00:12:13
there was no casey some progress to complete a fracture insisted
00:12:19
we are waiting the publication and problem probably a a more data and
00:12:25
well let's do the same with joe's tunic was nice and what is
00:12:29
the risk of fracture after joe tunic was is and again here i want
00:12:33
to focus on most of the patients but basically we don't have any
00:12:37
data and i sink that clearly this is the on it already news populations
00:12:45
we is put on charlie rhys factor of hybrid fragility because for example we know that
00:12:50
cost a cost or use is also a respectable forgotten because these tobacco alcohol and so on so
00:12:57
or the fact always fragility and this probably deep depend
00:13:01
of the patients itself and it has to be individualised
00:13:05
and i would say that we may discuss these that's probably the risk of fracture should be assessed
00:13:10
based on the clinical with factor of the patients and again of the b. m. d.
00:13:15
i did not mention the facts here because honestly i'm not convinced that facts clearly
00:13:21
evaluate or future risk of fracture in these patients with long term treatment with this was when it or so
00:13:28
now what is about uh the effects of our drugs
00:13:33
all the schools of our joe still it was nice
00:13:37
uh just to keep in mind i mentioned he is the right of joe still because he's in the was
00:13:44
still put take studies uh uh using out right then you can see that this is a right a rare events
00:13:50
uh between a zero point zero two two zero point
00:13:54
zero five percent it in these because when it's studies
00:13:57
um it there willow asked the even ten years of the no
00:14:01
two mad because it's only zero point three percent after ten years
00:14:05
and again regarding what was your mother and i would say the
00:14:09
sequence was mad then onto adoptive drags it was within the same order
00:14:15
so should we continue or discontinue beast was when it's a after a joint only crazies
00:14:22
for this case uh we don't have seen it dozens
00:14:26
sad discontinuing the onto adoptive drugs we improve the schools
00:14:31
of the jaw still nicholas when it happens whatever you do
00:14:36
finally this will not change the course of the of the
00:14:39
disease and nobody is the recommendation say is that uh the administration
00:14:45
of the beast was an act of the d. map
00:14:48
maybe these felt at the discretion of the treating physician incontinent
00:14:52
junction with discussion with the patients and the whole i'd have to provide a okay we are that we had with that
00:14:59
but um uh another recent study show that the drug holidays is not associated with the outcome
00:15:05
of more c. v. s. uh joe's tunic with this we require surgery and you don't need to
00:15:11
wait a drag holy day to consider the surgery of the georgian because he's it does not change
00:15:17
as the outcome rather than doing the surgery and and the
00:15:20
optimal management at uh at the the the beginning them so
00:15:25
it's more different pattern regarding the a typical summer factor regarding the onto adoptee products
00:15:31
now what about the early part tied shall make the
00:15:35
observation i'd case reports studies should just seems that telepathic
00:15:39
may promote the feeling of the job was the only
00:15:43
qualities and he if we have a placebo controlled randomised trial
00:15:49
who demonstrated that the use of the rubber tied we accelerate the healing
00:15:55
of the joystick with these in this control study so this is probably one of them might
00:16:00
must uh basically thence we have in this topic in favour of the repair tied in this complex
00:16:08
so this is where we ha and no i come back
00:16:12
to these two sides effect just to discuss some some consideration
00:16:16
so of course we are now convinced that many of these
00:16:20
patients remain at high risk of fracture after these side effects
00:16:26
so
00:16:27
always a useful to remind that it's important to take care
00:16:31
to the costume interact with vitamin d. to the values nutritional aspects
00:16:37
and two for prevention and promotion of physical activity ah as
00:16:40
far as possible this is always important to optimise these buttons now
00:16:46
knowing that are at risk of don't for g. t. how we knew manageable for each of these patients
00:16:52
should we consider a beast was when it's despite all was what i mentioned uh uh already uh uh idea
00:16:59
i would like to remind you that most of these
00:17:02
patients received more than save and eight nine years of treatment
00:17:06
and we perfect even though that after this
00:17:10
duration of treatment we do not expect any additional
00:17:15
gain on bone mineral density due to the pedal effects that we also with this was when it's
00:17:21
so even though i don't have that are showing these contacts what i expect based on the mechanism of action
00:17:27
we have to keep this in mind that i'm not tools that continuing to be so soon it will
00:17:31
be significantly increase might be in d. and my factories
00:17:36
ford did not smart the case might be potentially different
00:17:40
the second point regarding terry apartheid and this was discussed this morning we spent a line that
00:17:46
is that we know that the i'm not logic effect of to reply tied is low uh
00:17:52
after a long term treatment hopefully treatment with onto receptive products and this was when it's
00:17:58
and we know that we have greater be in the increase in naive patients
00:18:04
or in patients treated with um the sports when it's but with relatively low affinity
00:18:10
and we even have some data showing that the sequence of this was when it's to to reply
00:18:16
to add may even at least in the shop there decree the bone mineral density at the hip
00:18:24
and this is particularly relevant in the sequence of the news you map to to reply tight because as you know we should
00:18:31
discontinue the nose map you have the rebound of the boundary marlene
00:18:35
and that apartheid also increase the border marlene so you may expect
00:18:39
further a decrease of the bone mineral density that's why one of the question we ha but this
00:18:46
is an open question is that if we consider terry part that that may be interesting in some context
00:18:52
should we maybe consider a combination with an auntie was up to drugs
00:18:57
and my maybe this might be the best option especially after the nosy mob uh in these patients
00:19:04
but this is just some uh questions uh open uh and to into keeping
00:19:11
so to summarise um i think that's that's what
00:19:15
we can uh say today uh regarding the topic
00:19:20
we got the infraction research we know that the risk
00:19:23
is particularly high after on a typical from our fracture
00:19:27
and is mainly driven by the little of bone mineral
00:19:30
density you have at the time of the typical family factor
00:19:35
after and that and uh joe tunic was these honestly it's patient dependent
00:19:40
and i encourage you to look at the exact the clinical was factor
00:19:44
regarding the use of onto adoptive drives we know that um and uh after not to because
00:19:51
from our factor you increase the risk of competitive i typically more factor with onto resulted right
00:19:57
you'd it's not demonstrated that the continuation is the
00:20:01
data use in the cases of joe's tunic was this
00:20:04
and regarding is a prevention of future of two parts the cracked or we have no that
00:20:11
concerning terry apartheid we can say that potentially you have
00:20:15
a faster healing of surgically treated a typical german fracture
00:20:20
but the results regarding incomplete a typical from our factor out negative
00:20:25
with uh well one controller a randomised control trial
00:20:30
after at the uh joe till could make with these we have data showing that you promote the healing
00:20:35
of the joystick was this we still apartheid and again concerning most of the fracture we have no that
00:20:43
so that's where we ha and of course no this is open for discussion that
00:20:48
the t. v. set i seen that this should be an individual that lies a discussion
00:20:53
uh and with a monitoring of the b. a. n. d.'s a bottle markup probably had full
00:20:58
in this context uh but this is not a a new seeking the crustaceans thank you very much
00:21:08
thank you very much admired for his excellent presentation over challenging topic um all the questions
00:21:17
such a he's closer and you can run fast enough a minute
00:21:25
thank you very much indeed very complex topic so you see in the
00:21:29
in the yeah for a study from jail with that you publish these uh it was a uh you you
00:21:36
clearly show that after the f. f. where do you
00:21:39
stop we'll continue to drug no difference on fracture risk
00:21:45
but we know all that when we stop don't resort to the
00:21:49
reserve component or fracture decreases very fast right you have you know
00:21:53
a few more yeah so it seems to me that that is
00:21:56
clear right a. f. s. means stop don't result could absolutely or
00:22:02
that's why there's a consensus i mentioned was onto up to that point the consensus is you you we have to stop this one yeah
00:22:09
yes please not question no there's another question in the meanwhile for how long do
00:22:16
treat with paper applied visitation who had
00:22:19
when g. is that it's limited to sometime
00:22:25
um i think we have don't have here that ah is is the outcome is
00:22:30
to optimism the heating of the i think that a few moments or even weeks
00:22:36
so maybe enough now now if we consider patients with high risk of one for duty uh maybe we'll continue
00:22:43
uh for a longer period because study was one forty eight weeks yes yeah the commercial okay this is
00:22:50
good manners or your nice presentation so i take that back piece if you had that patients with
00:22:57
a typical ten last factor n. a. is on the wall she sounded the nelson had three things
00:23:03
hi allegedly rediscover bound affects a and the risk of getting at
00:23:08
this fascinates so increasing but then neither is common additive in fact
00:23:14
well so the way cases we had on the nose tomorrow
00:23:19
we manages them by continuing to those in math and adding to read about that
00:23:26
and and we and we follow and we follow the the bond market we for
00:23:30
those are the symptoms it also depends is i had a comparative allocating or not
00:23:36
but um this is one option the second option is also
00:23:40
depends because some of these patients may have that confirm affected
00:23:44
under the nose amount but receive before the no zoom out long value out of
00:23:48
the source and it's and in this case you do not expect that a huge reborn
00:23:53
but i would say that this is not complain because we had one case like this and we did not expecting rebound and
00:23:59
finally the patient kind of a you would rebound and we had
00:24:02
to go back to the the map pressed every part that so
00:24:07
this is clearly a case by case that age and on the other way what i i'm doing in that i
00:24:12
will be more keen to use oral pieces when it's to maintain this it takes levels in between i would say
00:24:19
uh and i will be made less stringent in the target of cities
00:24:24
but to avoid a a huge depression of the bone remote leans that may promote a a new at typical firmer factor
00:24:31
and meanwhile to avoid the let's say the they go up to a very high one remote wedding
00:24:37
and and follows as also with wood and thank you very much i wonder is there any other question
00:24:44
otherwise i would like to thank you and would like to close the session and

Conference Program

Introduction
Pr. Dr. S. Ferrari, Geneva
May 13, 2022 · 11:45 a.m.
Romosozumab clinical data
Pr. Dr. B. Langdahl, Aarhus, DK
May 13, 2022 · 11:50 a.m.
118 views
Romosozumab limitation (CH): challenges and opportunities
Pr. Dr. S. Ferrari, Geneva
May 13, 2022 · 12:25 p.m.
Questions & Answers Session
May 13, 2022 · 12:40 p.m.
Short- or long-term denosumab therapy? Part 1
Dr. J. Everts-Graber, Bern
May 13, 2022 · 1:37 p.m.
401 views
Short- or long-term denosumab therapy? Part 2
Pr. Dr. S. Ferrari, Geneva
May 13, 2022 · 1:52 p.m.
Vitamin D: when to measure, what supplement?
Prof. Dr. H. Bischoff-Ferrari, Zürich
May 13, 2022 · 2:13 p.m.
Dietary calcium intake : How much, from where, for whom?
Dr. M. Papagiorgeou, Geneva
May 13, 2022 · 2:42 p.m.
Treatment of bone fragility in CRF
Pr.Dr O. Lamy, Lausanne
May 13, 2022 · 3:27 p.m.
Osteoporosis treatment after AFF and ONJ
Dr. PD E Biver, Geneva
May 13, 2022 · 3:55 p.m.