Introduction
Methods
Scientific committee
Expert panel
Questionnaire
Definition of consensus
Chronogram of Delphi rounds
Data analyses
Ethical aspects
Results
Participants’ characteristics
Achieved consensus
Question | Wish (%) | Prognosis (%) | ||||
---|---|---|---|---|---|---|
A | I | D | A | I | D | |
For establishing a therapeutic objective, has to be considered | ||||||
a. patient age |
97.3
| 0.9 | 1.8 |
98.2
| 0.9 | 0.9 |
b. baseline T-score |
94.6
| 1.8 | 3.6 |
94.6
| 2.7 | 2.7 |
The therapeutic objective is to be achieved | ||||||
a. rapidly |
75.0
| 2.7 | 22.3 |
93.4
| 3.8 | 2.8 |
b. constantly and consistently maintained |
96.4
| 1.8 | 1.8 |
93.8
| 3.6 | 2.7 |
The following parameters could be used as therapeutic objectives in the context of the T2T strategy in osteoporosis | ||||||
a. BTM |
86.8
| 3.8 | 9.4 | 60.6 | 10.4 | 29.2 |
b. BMD |
91.1
| 0.9 | 8.0 |
91.1
| 6.3 | 2.7 |
c. fracture risk reduction measured FRAX |
75.9
| 8.0 | 16.1 |
84.0
| 6.6 | 9.4 |
d. absence of new fractures |
99.1
| – | 0.9 |
97.3
| 0.9 | 1.8 |
The BMD (measured with the T-score) has to be used as the principal parameter for defining an adequate therapeutic objective in the context of the T2T strategy in osteoporosis |
83.0
| 1.8 | 15.2 |
83.9
| 4.5 | 11.6 |
If BMD is used as the principal parameter for defining an adequate therapeutic objective, it has to be measured using a | ||||||
a. tangible absolute value |
88.7
| – | 11.3 |
92.5
| 0.9 | 6.6 |
b. predetermined difference between two values |
85.7
| 7.1 | 7.1 |
82.1
| 12.5 | 5.4 |
If BMD is used as the principal parameter for defining an adequate therapeutic objective, the target lumbar spine T-score to be achieved is | ||||||
a. >−2.5 SD |
75.9
| 8.0 | 16.1 |
92.5
| 0.9 | 6.6 |
b. >−2.0 SD | 64.3 | 13.4 | 22.3 | 53.6 | 24.1 | 22.3 |
c. >−1.5 SD | 39.9 | 19.6 | 41.1 | 30.4 | 25.9 | 43.8 |
d. >−1.0 SD | 24.1 | 21.4 | 54.5 | 18.8 | 22.3 | 58.9 |
e. an increment of 2 SD with reference to the baseline BMD |
81.1
| 3.8 | 15.1 |
83.0
| 3.8 | 13.2 |
f. an increment in the basal BMD (any change) |
86.8
| 2.8 | 10.4 |
86.8
| 4.7 | 8.5 |
If BMD is used as the principal parameter for defining an adequate therapeutic objective, the target femoral (femoral neck of total hip) T-score to be achieved is | ||||||
a. >−2.5 SD |
79.5
| 3.6 | 17.0 |
79.5
| 7.1 | 13.4 |
b. >−2.0 SD |
77.7
| 7.1 | 15.2 |
93.4
| 1.9 | 4.7 |
c. >−1.5 SD | 46.4 | 14.3 | 39.3 | 38.4 | 22.3 | 39.3 |
d. >−1.0 SD | 30.4 | 15.2 | 54.5 | 23.2 | 18.8 | 58.0 |
e. an increment of 2 SD with reference to the baseline BMD |
84.9
| 4.7 | 10.4 |
84.0
| 3.8 | 12.3 |
f. an increment in the basal BMD (any change) |
86.8
| 10.4 | 2.8 |
86.8
| 3.8 | 9.4 |
If fracture risk reduction is used as the principal parameter for defining an adequate therapeutic objective, it has to be measured using | ||||||
a. FRAX |
85.8
| 2.8 | 11.3 |
87.7
| 4.7 | 7.5 |
b. Q-fracture | 59.4 | 24.5 | 16.0 | 31.1 | 54.7 | 14.2 |
c. Garvan | 28.3 | 40.6 | 31.1 | 9.4 | 74.5 | 16.0 |
If fracture risk reduction is used as the principal parameter for defining an adequate therapeutic objective, it has to be measured using a | ||||||
a. tangible percentage |
89.6
| 2.8 | 7.5 |
91.5
| 2.8 | 5.7 |
b. predetermined difference between two values |
86.8
| 4.7 | 8.5 |
87.7
| 5.7 | 6.6 |
If fracture risk reduction measured by FRAX is used as the principal parameter for defining an adequate therapeutic objective, the risk of major fractures (hip, vertebral, femur, humerus, and radius) has to be lower than | ||||||
a. 5% | 55.7 | 1.9 | 42.5 | 50.9 | 2.8 | 46.2 |
b. 7.5% | 72.6 | 2.8 | 24.5 | 63.2 | 5.7 | 31.1 |
c. 10% |
75.5
| 2.8 | 21.7 | 68.9 | 4.7 | 26.4 |
d. 20% | 43.4 | 1.9 | 54.7 | 41.5 | 3.8 | 54.7 |
If the absence of new fractures is used as the principal parameter for defining an adequate therapeutic objective, the incidence of fractures has to be measured using | ||||||
a. VFA |
83.0
| 10.7 | 6.3 |
92.5
| 0.9 | 6.6 |
b. height |
75.9
| 8.9 | 15.2 |
94.3
| 2.8 | 2.8 |
c. conventional X-ray |
88.4
| 5.4 | 6.3 |
83.9
| 8.0 | 8.0 |
d. major nonvertebral fragility fracture (humerus, radius, and femur) |
96.4
| 2.7 | 0.9 |
95.5
| 2.7 | 1.8 |
e. any fracture (including pelvic branches and other long bones) |
91.1
| 7.1 | 1.8 |
85.7
| 8.9 | 5.4 |
BTM are good therapeutic indicators for | ||||||
a. determining the therapeutic objective |
79.2
| 5.7 | 15.1 | 64.2 | 5.7 | 30.2 |
b. selecting population to be treated | 29.2 | 5.7 | 65.1 | 21.7 | 5.7 | 72.6 |
c. establishing a therapeutic strategy | 52.8 | 9.4 | 37.7 | 43.4 | 9.4 | 47.2 |
d. performing treatment follow-up |
83.9
| 7.1 | 8.9 |
78.6
| 11.6 | 9.8 |
If BTM are used as the principal parameter for defining an adequate therapeutic objective, they have to be measured using a | ||||||
a. tangible absolute value | 58.5 | 7.5 | 34.0 | 42.5 | 10.4 | 47.2 |
b. predetermined difference between two values |
79.5
| 10.7 | 9.8 |
95.3
| 3.8 | 0.9 |
Question | Wish (%) | Prognosis (%) | ||||
---|---|---|---|---|---|---|
A | I | D | A | I | D | |
For monitoring the BMD in patients already treated, the following anatomic can be useful: | ||||||
a. lumbar spine |
96.4
| 0.9 | 2.7 |
96.4
| 0.9 | 2.7 |
b. femoral neck |
99.1
| – | 0.9 |
98.2
| 1.8 | – |
c. total hip |
92.0
| 5.4 | 2.7 |
92.0
| 6.3 | 1.8 |
Question | Wish (%) | Prognosis (%) | ||||
---|---|---|---|---|---|---|
A | I | D | A | I | D | |
The T2T strategy in osteoporosis is possible with the following anti-osteoporotic treatment: | ||||||
a. oral bisphosphonates |
88.4
| 5.4 | 6.3 |
88.4
| 3.6 | 8.0 |
b. intravenous bisphosphonates |
92.0
| 6.3 | 1.8 |
89.3
| 6.3 | 4.5 |
c. SERM |
94.3
| 1.9 | 3.8 |
96.2
| – | 3.8 |
d. strontium ranelate |
76.4
| 5.7 | 17.9 | 58.5 | 4.7 | 36.8 |
e. denosumab |
97.3
| 1.8 | 0.9 |
94.6
| 3.6 | 1.8 |
f. teriparatide |
96.4
| 1.8 | 1.8 |
92.0
| 4.5 | 3.6 |
g. denosumab plus teriparatide |
80.4
| 11.6 | 8.0 |
78.6
| 10.7 | 10.7 |
h. developing treatments |
86.6
| 11.6 | 1.8 |
81.3
| 13.4 | 5.4 |
In patients treated with bisphosphonates, once the therapeutic objective has been reached, the treatment has to be | ||||||
a. stopped for a period of time (drug holiday) |
81.3
| 2.7 | 16.1 |
77.7
| 6.3 | 16.1 |
b. continued indefinitely | 12.5 | 1.8 |
85.7
| 10.7 | 9.8 |
79.5
|
c. switched | 5.7 | 1.9 |
92.5
| 5.7 | 1.9 |
92.5
|
In patients treated with SERM, once the therapeutic objective has been reached, the treatment has to be | ||||||
a. stopped for a period of time (drug holiday) | 34.0 | 3.8 | 62.3 | 36.8 | 4.7 | 8.5 |
b. continued indefinitely | 16.1 | 7.1 | 76.8 | 17.0 | 8.0 | 75.0 |
c. switched | 32.1 | 4.7 | 63.2 | 26.4 | 7.5 | 66.0 |
In patients treated with strontium ranelate, once the therapeutic objective has been reached, the treatment has to be | ||||||
a. stopped for a period of time (drug holiday) |
84.0
| 7.5 | 8.5 |
83.0
| 8.5 | 8.5 |
b. continued indefinitely | 8.9 | 8.0 |
83.0
| 8.9 | 10.7 |
80.4
|
c. switched | 67.9 | 6.6 | 25.5 | 68.9 | 6.6 | 24.5 |
In patients treated with teriparatide, once the therapeutic objective has been reached, the treatment has to be | ||||||
a. stopped for a period of time (drug holiday) |
75.5
| 1.9 | 22.6 |
76.4
| 1.9 | 21.7 |
b. continued indefinitely | 3.6 | 2.7 |
93.8
| 2.7 | 4.5 |
92.9
|
c. switched |
80.4
| 3.6 | 16.1 | 77.7 | 5.4 | 17.0 |
In patients treated with denosumab, once the therapeutic objective has been reached, the treatment has to be | ||||||
a. stopped for a period of time (drug holiday) |
81.1
| – | 18.9 |
84.9
| – | 15.1 |
b. continued indefinitely | 8.5 | – |
91.5
| 6.6 | 0.9 |
92.5
|
c. switched | 15.1 | 2.8 |
82.1
| 12.3 | 3.8 |
84.0
|
Question | Wish (%) | Prognosis (%) | ||||
---|---|---|---|---|---|---|
A | I | D | A | I | D | |
Therapeutic failure is to be considered when the BMD increment is not achieved in | ||||||
a. 6 months | 8.9 | 2.7 |
88.4
| 5.4 | 8.0 |
86.6
|
b. 1 year | 35.7 | 4.5 | 59.8 | 33.9 | 8.9 | 57.1 |
c. 2 years |
81.3
| 6.3 | 12.5 |
82.1
| 4.5 | 13.4 |
d. 3 years |
77.7
| 8.0 | 14.3 |
75.9
| 9.8 | 14.3 |
e. 5 years | 67.0 | 9.8 | 23.2 | 65.2 | 11.6 | 23.2 |
f. >5 years | 51.8 | 13.4 | 34.8 | 48.2 | 19.6 | 32.1 |
Therapeutic failure is to be considered when a new fracture is diagnosed in the following: | ||||||
a. 6 months | 38.4 | 6.3 | 55.4 | 33.9 | 10.7 | 55.4 |
b. 1 year |
77.7
| 8.0 | 14.3 |
77.7
| 8.0 | 14.3 |
c. 2 years |
92.0
| 2.7 | 5.4 |
92.0
| 4.5 | 3.6 |
d. 3 years |
90.2
| 4.5 | 5.4 |
88.4
| 7.1 | 4.5 |
e. 5 years |
79.5
| 8.9 | 11.6 |
79.5
| 9.8 | 10.7 |
f. >5 years | 69.6 | 11.6 | 18.8 | 68.8 | 13.4 | 17.9 |
Therapeutic failure is to be considered when a significant change in bone-remodeling markers is not achieved in the following: | ||||||
a. 1 month | 1.9 | 3.8 |
94.3
| 0.9 | 3.8 |
95.3
|
b. 3 months | 73.6 | 4.7 | 21.7 | 59.4 | 6.6 | 34.0 |
c. 6 months |
75.0
| 16.1 | 8.9 |
93.4
| 2.8 | 3.8 |
d. 1 year |
90.6
| 4.7 | 4.7 |
89.6
| 5.7 | 4.7 |
e. 2 years | 68.9 | 4.7 | 26.4 | 67.9 | 5.7 | 26.4 |
f. >2 years | 65.1 | 2.8 | 32.1 | 61.3 | 4.7 | 34.0 |