Nama : dr.

DYA ANGGRAENI
NIM : 04072711822003
Prog. Studi : NEUROLOGI

SYSTEMATIC REVIEW (OF THERAPY) WORKSHEET

Citation:
Geusens P, Marin F,Kendler DL et al. Effects of Teriparatide Compared with
Risedronate on the Risk of Fractures in Subgroups of Postmenopausal Women with
Severe Osteoporosis: The VERO Trial. Journal of Bone and Mineral Research 2018;
33:1–12.

Are the results of this systematic review valid?

Is this a systematic review of randomised Yes

trials?
Does it include a methods section that
describes:
a) finding and including all relevant trials?
b) assessing their individual validity?
Were the results consistent from study to
study?
Were the individual patient data used in the
analysis (or aggregate data)?
This is a systematic review of
double-blind, multinational,
multicenter trial which examines
effects of teriparatide compared with
risedronate on the risk of fractures in
subgroups of postmenopausal
women with severe osteoporosis
a) Yes, it does. Methods section
describe finding and including all
relevant trials, especially from
“VERtebral fracture treatment
comparisons in Osteoporotic
women” (VERO) trial
b) Not explained. Method section
does not describe about
assessment of individual validity
Yes
The results consistent with two
previous double dummy, active
controlled trials that included the
comparison the fracture incidence
between groups as secondary or
explanatory endpoints (Hadji and
colleagues &Saag and colleagues).
There was no evidence of
heterogeneity in treatment effect
across the different categories of the
subgroups in reducing the risk of
new vertebral fracture or clinical
fractures.
Yes
Aggregate data were used in the
analysis. Subgroup analyses of
 fracture data across subgroups,
which were predefined by the
following baseline characteristics:
age, number and severity of
prevalent VFx, prevalent
nonvertebral fractures (NVFx),
glucocorticoid use, prior
osteoporosis drugs, recent
bisphosphonate use,clinical VFx in
the year before study entry, and
baseline BMD.

Are the valid results of this systematic review important? Yes

Relative risk ratio for pooled new and worsened vertebral fracture by overall VERO
populations is 0,46.
This means teriparatide compared with risedronate decreases the risk of new and
worsened vertebral fracture in postmenopausal women with severe osteoporosis. Data for
the first time indicate the additional fracture benefit of using an anabolic compared with
an antiresorptive across multiple patient clinical scenarios. This information should aid in
positioning teriparatide bone anabolic therapy for reduction of residual fracture burden in
patients at high fracture risk who are either treatment-naive or on bisphosphonate
treatment.

Translating odds ratios to NNTs:

The numbers in the body of the tables are the NNTs for the corresponding odds ratio at
that particular patient’s expected event rate (PEER).

1. When the odds ratio (OR) < 1

This table applies when a bad outcome is prevented by therapy.
OR < 1
0.9 0.8 0.7 0.6 0.5
0.05 2.09a 104 69 52 41b
Patient’s 0.10 110 54 36 27 21
expected 0.20 61 30 20 14 11
event rate 0.30 46 22 14 10 8
(PEER) 0.40 40 19 12 9 7
0.50 38 18 11 8 6
0.70 44 20 13 9 6
0.90 101c 46 27 18 12d

a The relative risk reduction (RRR) here is 10%

b The RRR here is 49%
c For any OR, NNT is lowest when PEER = 0.50
d The RRR here is 9%
Can you apply this valid, important evidence from a systematic review in caring for
your patient?

Do these results apply to our patient?

Is your patient so different from those in No
the study that its results cannot apply? The patient is not so different from those
in the study so its results can apply. In
postmenopausal women with severe
osteoporosis, the antifracture efficacy of
teriparatide compared with risedronate
was consistent in a wide range of patient
settings, including treatment-naive and
previously treated patients.
Is the treatment feasible in your setting? Yes
The treatment is feasible in our setting
because the drugs are available in
Indonesia.
What are your patient’s potential benefits and harms from the therapy?
Relative risk ratio for pooled new and worsened vertebral fracture by overall VERO
populations is 0,46.
This means teriparatide compared with risedronate decreases the risk of new and
worsened vertebral fracture in postmenopausal women with severe osteoporosis.
Method I: In the OR tables above, find the
intersection of the closest odds ratio from
the systematic review and your patient’s
expected event rate (PEER)
Method II: To calculate the NNT from any
OR and PEER:
1  PEER  1  OR 
NNT 
(1  PEER)  PEER  (1  OR )
Are your patient’s values and preferences satisfied by the regimen and its
consequences?
Do you and your patient have a clear Yes
assessment of their values and preferences? We have a clear assessment of our values
and preferences. In this study, we assess
the patient by explanatory subgroup
analysis using the standard statistical test
Are they met by this regimen and its Yes
consequences? They are met by this regimen and its
consequences. Teriparatide antifracture
efficacy is similarly superior to
risedronate in both osteoporosis
treatment-naıve and prior bisphosphonate-
treated patients.
Should you believe apparent qualitative differences in the efficacy of therapy in
some subgroups of patients?—Only if you can say ‘yes’ to all of the following:
Do they really make biologic and clinical
sense?
Is the qualitative difference both clinically
(beneficial for some but useless or harmful
for others) and statistically significant?
Was this difference hypothesised before
the study began (rather than the product of
dredging the data), and has it been
confirmed in other, independent studies?
Was this one of just a few subgroup
analyses carried out in this study?
Additional notes:
Yes, they really make biologic and
clinical sense because this study assesses
the patient based on biologic and clinical
parameter, including BMD T-score and
semiquantitative grading (SQ) scale by
Genant and colleagues.
No, it is not.
In postmenopausal women with severe
osteoporosis, the antifracture efficacy of
teriparatide compared with risedronate
was consistent in a wide range of patient
settings, including treatment-naıve and
previously treated patients.
Yes, it was.
This difference hyposthesised before the
study began dan confirmed in Kendler
and colleagues study.
No, it was not.
Teriparatide can effectively reduce this
residual fracture burden in these severely
osteoporotic patients, with an absolute
risk reduction in new VFx of 6.6% after
24 months of treatment and a consistent
effect over the widerange of subgroups
analyzed.