Trial Outcomes & Findings for Evaluation of the Effects of Teriparatide on Skeleton Images in Postmenopausal Women With Osteoporosis (NCT NCT00259298)
NCT ID: NCT00259298
Last Updated: 2010-08-11
Results Overview
Skeletal plasma clearance is defined as the volume of plasma cleared of tracer (99m Tc-MDP) by the skeleton per unit time (milliliter/minute). Kbone is the rate constant representing plasma clearance of tracer to bone. The Patlak plot method was used to evaluate whole skeleton 99mTc-MDP skeletal plasma clearance (Kbone).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
12 participants
Primary outcome timeframe
baseline, 18 months
Results posted on
2010-08-11
Participant Flow
Participant milestones
| Measure |
Teriparatide
Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
10
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Teriparatide
Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
Evaluation of the Effects of Teriparatide on Skeleton Images in Postmenopausal Women With Osteoporosis
Baseline characteristics by cohort
| Measure |
Teriparatide
n=12 Participants
Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
|
|---|---|
|
Age Continuous
|
67.17 years
STANDARD_DEVIATION 7.64 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
12 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
12 participants
n=5 Participants
|
|
Qualitative Visual Assessment of Diffuse Uptake of 99m Technetium methylene diphosphonate
no increase
|
10 participants
n=5 Participants
|
|
Qualitative Visual Assessment of Diffuse Uptake of 99m Technetium methylene diphosphonate
possible increase
|
0 participants
n=5 Participants
|
|
Qualitative Visual Assessment of Diffuse Uptake of 99m Technetium methylene diphosphonate
definite increase
|
0 participants
n=5 Participants
|
|
Qualitative Visual Assessment of Diffuse Uptake of 99m Technetium methylene diphosphonate
not assessed
|
2 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
24.56 kg/m2
STANDARD_DEVIATION 5.16 • n=5 Participants
|
|
Height
|
161.25 centimeter
STANDARD_DEVIATION 6.88 • n=5 Participants
|
|
Qualitative Visual Score of Focal uptake of 99m Technetium methylene diphosphonate (99m Tc-MDP)
|
0.7 units on scale
STANDARD_DEVIATION 0.48 • n=5 Participants
|
|
Skeletal plasma clearance of 99m Technetium methylene diphosphonate (99m Tc-MDP)
whole skeleton
|
38.30 milliliter/minute
n=5 Participants
|
|
Skeletal plasma clearance of 99m Technetium methylene diphosphonate (99m Tc-MDP)
skull
|
3.07 milliliter/minute
n=5 Participants
|
|
Skeletal plasma clearance of 99m Technetium methylene diphosphonate (99m Tc-MDP)
mandible
|
0.17 milliliter/minute
n=5 Participants
|
|
Skeletal plasma clearance of 99m Technetium methylene diphosphonate (99m Tc-MDP)
spine
|
6.32 milliliter/minute
n=5 Participants
|
|
Skeletal plasma clearance of 99m Technetium methylene diphosphonate (99m Tc-MDP)
pelvis
|
5.92 milliliter/minute
n=5 Participants
|
|
Skeletal plasma clearance of 99m Technetium methylene diphosphonate (99m Tc-MDP)
upper extremities
|
3.70 milliliter/minute
n=5 Participants
|
|
Skeletal plasma clearance of 99m Technetium methylene diphosphonate (99m Tc-MDP)
lower extremities
|
9.12 milliliter/minute
n=5 Participants
|
|
Skeletal uptake of 99m Technetium methylene diphosphonate (99m Tc-MDP)
whole skeleton
|
29.4 percentage of uptake
n=5 Participants
|
|
Skeletal uptake of 99m Technetium methylene diphosphonate (99m Tc-MDP)
skull
|
2.59 percentage of uptake
n=5 Participants
|
|
Skeletal uptake of 99m Technetium methylene diphosphonate (99m Tc-MDP)
mandible
|
0.14 percentage of uptake
n=5 Participants
|
|
Skeletal uptake of 99m Technetium methylene diphosphonate (99m Tc-MDP)
spine
|
4.85 percentage of uptake
n=5 Participants
|
|
Skeletal uptake of 99m Technetium methylene diphosphonate (99m Tc-MDP)
pelvis
|
4.57 percentage of uptake
n=5 Participants
|
|
Skeletal uptake of 99m Technetium methylene diphosphonate (99m Tc-MDP)
upper extremities
|
2.98 percentage of uptake
n=5 Participants
|
|
Skeletal uptake of 99m Technetium methylene diphosphonate (99m Tc-MDP)
lower extremities
|
7.09 percentage of uptake
n=5 Participants
|
|
Weight
|
63.80 kilogram
STANDARD_DEVIATION 13.56 • n=5 Participants
|
|
Years post menopause
|
21.84 years
STANDARD_DEVIATION 7.65 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 18 monthsPopulation: All participants with a baseline observation and at least 1 post-baseline observation.
Skeletal plasma clearance is defined as the volume of plasma cleared of tracer (99m Tc-MDP) by the skeleton per unit time (milliliter/minute). Kbone is the rate constant representing plasma clearance of tracer to bone. The Patlak plot method was used to evaluate whole skeleton 99mTc-MDP skeletal plasma clearance (Kbone).
Outcome measures
| Measure |
Teriparatide
n=10 Participants
Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
|
|---|---|
|
Change From Baseline in Whole Skeleton Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) to 18 Months
|
33.75 percentage of change of plasma clearance
Interval 29.97 to 50.91
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 18 months, 24 monthsPopulation: All participants with a baseline observation and at least 1 post-baseline observation.
Skeletal plasma clearance is defined as the volume of plasma cleared of tracer (99m Tc-MDP) by the skeleton per unit time (milliliter/minute). Kbone is the rate constant representing plasma clearance of tracer to bone. The Patlak plot method was used to evaluate whole skeleton 99mTc-MDP skeletal plasma clearance (Kbone) and to derive regional values for the skull, mandible, spine, pelvis, and upper and lower extremities.
Outcome measures
| Measure |
Teriparatide
n=10 Participants
Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
|
|---|---|
|
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Lower extremities, baseline to 24 months, n=9
|
7.07 percentage of change of plasma clearance
Interval -8.08 to 15.77
|
|
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Lower extremities, 3 months to 18 months, n=10
|
12.72 percentage of change of plasma clearance
Interval -12.14 to 24.74
|
|
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Lower extremities, 18 months to 24 months, n=9
|
-20.72 percentage of change of plasma clearance
Interval -21.81 to -13.55
|
|
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Whole skeleton, baseline to 3 months, n=10
|
25.02 percentage of change of plasma clearance
Interval 14.21 to 30.73
|
|
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Whole skeleton, baseline to 24 months, n=9
|
3.52 percentage of change of plasma clearance
Interval -8.27 to 11.93
|
|
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Whole skeleton, 3 months to 18 months, n=10
|
10.44 percentage of change of plasma clearance
Interval 7.83 to 21.0
|
|
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Whole skeleton, 18 months to 24 months, n=9
|
-22.20 percentage of change of plasma clearance
Interval -24.35 to -18.39
|
|
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Skull, baseline to 3 months, n=8
|
72.25 percentage of change of plasma clearance
Interval 42.19 to 106.56
|
|
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Skull, baseline to 18 months, n=8
|
128.44 percentage of change of plasma clearance
Interval 97.38 to 162.55
|
|
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Skull, baseline to 24 months, n=7
|
21.20 percentage of change of plasma clearance
Interval 8.0 to 54.9
|
|
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Skull, 3 months to 18 months, n=8
|
31.01 percentage of change of plasma clearance
Interval 17.65 to 47.29
|
|
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Skull, 18 months to 24 months, n=7
|
-37.87 percentage of change of plasma clearance
Interval -45.64 to -32.14
|
|
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Mandible, baseline to 3 months, n=8
|
65.94 percentage of change of plasma clearance
Interval 26.56 to 106.76
|
|
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Mandible, baseline to 18 months, n=8
|
60.99 percentage of change of plasma clearance
Interval 31.25 to 127.78
|
|
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Mandible, baseline to 24 months, n=7
|
21.05 percentage of change of plasma clearance
Interval -6.9 to 82.35
|
|
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Mandible, 3 months to 18 months, n=8
|
4.55 percentage of change of plasma clearance
Interval -3.25 to 15.13
|
|
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Mandible, 18 months to 24 months, n=7
|
-17.39 percentage of change of plasma clearance
Interval -25.81 to -10.0
|
|
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Spine, baseline to 3 months, n=10
|
17.31 percentage of change of plasma clearance
Interval 0.46 to 35.53
|
|
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Spine, baseline to 18 months, n=10
|
33.81 percentage of change of plasma clearance
Interval 7.53 to 57.99
|
|
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Spine, baseline to 24 months, n=9
|
16.94 percentage of change of plasma clearance
Interval -0.14 to 32.99
|
|
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Spine, 3 months to 18 months, n=10
|
14.10 percentage of change of plasma clearance
Interval -0.23 to 20.0
|
|
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Spine, 18 months to 24 months, n=9
|
-9.42 percentage of change of plasma clearance
Interval -15.31 to 8.31
|
|
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Pelvis, baseline to 3 months, n=10
|
20.26 percentage of change of plasma clearance
Interval 5.0 to 43.59
|
|
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Pelvis, baseline to 18 months, n=10
|
8.36 percentage of change of plasma clearance
Interval 4.15 to 28.23
|
|
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Pelvis, baseline to 24 months, n=9
|
-5.58 percentage of change of plasma clearance
Interval -14.19 to 10.65
|
|
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Pelvis, 3 months to 18 months, n=10
|
-3.29 percentage of change of plasma clearance
Interval -15.75 to 2.15
|
|
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Pelvis, 18 months to 24 months, n=9
|
-13.81 percentage of change of plasma clearance
Interval -17.61 to 2.26
|
|
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Upper extremities, baseline to 3 months, n=10
|
42.52 percentage of change of plasma clearance
Interval 8.92 to 91.09
|
|
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Upper extremities, baseline to 18 months, n=10
|
95.49 percentage of change of plasma clearance
Interval 62.52 to 146.1
|
|
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Upper extremities, baseline to 24 months, n=9
|
62.76 percentage of change of plasma clearance
Interval 31.07 to 70.24
|
|
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Upper extremities, 3 months to 18 months, n=10
|
45.84 percentage of change of plasma clearance
Interval 24.27 to 77.33
|
|
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Upper extremities, 18 months to 24 months, n=9
|
-19.35 percentage of change of plasma clearance
Interval -27.59 to 1.18
|
|
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Lower extremities, baseline to 3 months, n=10
|
20.98 percentage of change of plasma clearance
Interval 3.71 to 50.16
|
|
Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
Lower extremities, baseline to 18 months, n=10
|
34.88 percentage of change of plasma clearance
Interval 16.65 to 67.09
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 18 months, 24 monthsPopulation: All participants with a baseline observation and at least 1 post-baseline observation.
Skeletal uptake describes the percent uptake of radionuclide tracer by the skeleton when compared to baseline or other post-baseline measures. Skeletal uptake is defined as percentage of uptake of 99mTc-MDP 4 hours after injection. This value differs from skeletal plasma clearance measurements because it only quantifies the amount of 99mTc-MDP taken up by bone without consideration of concentration of tracer in the plasma.
Outcome measures
| Measure |
Teriparatide
n=10 Participants
Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
|
|---|---|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
whole skeleton, baseline to 3 months, n=10
|
15.63 percentage of change of skeletal uptake
Interval 4.93 to 28.89
|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
whole skeleton, baseline to 18 months, n=10
|
26.12 percentage of change of skeletal uptake
Interval 11.81 to 37.31
|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
whole skeleton, baseline to 24 months, n=9
|
5.68 percentage of change of skeletal uptake
Interval -9.86 to 8.03
|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
whole skeleton, 3 months to 18 months, n=10
|
3.99 percentage of change of skeletal uptake
Interval -5.56 to 14.44
|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
whole skeleton, 18 months to 24 months, n=9
|
-14.54 percentage of change of skeletal uptake
Interval -19.35 to -13.41
|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
skull, baseline to 3 months, n=8
|
68.27 percentage of change of skeletal uptake
Interval 32.45 to 90.26
|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
skull, baseline to 18 months, n=8
|
120.85 percentage of change of skeletal uptake
Interval 83.57 to 137.47
|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
skull, baseline to 24 months, n=7
|
26.87 percentage of change of skeletal uptake
Interval 3.31 to 50.99
|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
skull, 3 months to 18 months, n=8
|
23.63 percentage of change of skeletal uptake
Interval 15.75 to 50.43
|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
skull, 18 months to 24 months, n=7
|
-34.36 percentage of change of skeletal uptake
Interval -39.86 to -28.93
|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
mandible, baseline to 3 months, n=8
|
52.20 percentage of change of skeletal uptake
Interval 11.01 to 77.31
|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
mandible, baseline to 18 months, n=8
|
62.91 percentage of change of skeletal uptake
Interval 6.25 to 118.33
|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
mandible, baseline to 24 months, n=7
|
23.08 percentage of change of skeletal uptake
Interval -8.0 to 71.43
|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
mandible, 3 months to 18 months, n=8
|
3.85 percentage of change of skeletal uptake
Interval -6.45 to 14.64
|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
mandible, 18 to 24 months, n=7
|
-6.25 percentage of change of skeletal uptake
Interval -23.81 to -4.17
|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
spine, baseline to 3 months, n=10
|
12.15 percentage of change of skeletal uptake
Interval -4.45 to 21.92
|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
spine, baseline to 18 months, n=10
|
17.77 percentage of change of skeletal uptake
Interval -3.76 to 40.5
|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
spine, baseline to 24 months, n=9
|
17.68 percentage of change of skeletal uptake
Interval 6.92 to 38.5
|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
spine, 3 months to 18 months, n=10
|
13.36 percentage of change of skeletal uptake
Interval -9.34 to 29.41
|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
spine, 18 months to 24 months, n=9
|
-0.19 percentage of change of skeletal uptake
Interval -5.04 to 7.63
|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
pelvis, baseline to 3 months, n=10
|
14.26 percentage of change of skeletal uptake
Interval -0.6 to 40.06
|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
pelvis, baseline to 18 months, n=10
|
-1.21 percentage of change of skeletal uptake
Interval -8.33 to 31.41
|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
pelvis, baseline to 24 months, n=9
|
-1.48 percentage of change of skeletal uptake
Interval -10.8 to 6.19
|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
pelvis, 3 months to 18 months, n=10
|
-3.70 percentage of change of skeletal uptake
Interval -18.24 to 3.47
|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
pelvis, 18 months to 24 months, n=9
|
-5.23 percentage of change of skeletal uptake
Interval -8.47 to 3.1
|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
upper extremities, baseline to 3 months, n=10
|
31.59 percentage of change of skeletal uptake
Interval 17.21 to 53.87
|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
upper extremities, baseline to 18 months, n=10
|
76.58 percentage of change of skeletal uptake
Interval 48.76 to 120.47
|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
upper extremities, baseline to 24 months, n=9
|
57.82 percentage of change of skeletal uptake
Interval 35.95 to 74.24
|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
upper extremities, 3 months to 18 months, n=10
|
48.58 percentage of change of skeletal uptake
Interval 25.17 to 59.96
|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
upper extremities, 18 months to 24 months, n=9
|
-10.13 percentage of change of skeletal uptake
Interval -18.07 to 0.4
|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
lower extremities, baseline to 3 months, n=10
|
9.25 percentage of change of skeletal uptake
Interval 3.64 to 54.37
|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
lower extremities, baseline to 18 months, n=10
|
23.98 percentage of change of skeletal uptake
Interval 10.53 to 52.89
|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
lower extremities, baseline to 24 months, n=9
|
0.86 percentage of change of skeletal uptake
Interval -4.37 to 13.33
|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
lower extremities, 3 months to 18 months, n=10
|
7.58 percentage of change of skeletal uptake
Interval -3.71 to 22.31
|
|
Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities
lower extremities, 18 months to 24 months, n=9
|
-16.99 percentage of change of skeletal uptake
Interval -19.94 to -2.17
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 18 months, 24 monthsPopulation: All participants with a baseline observation and at least 1 post-baseline observation.
Changes in focal uptake (localized, defined areas of uptake) were visually scored and compared to baseline or other post-baseline assessments. Changes were rated on a scale from 0-4: 0=no clinically significant focal areas of skeletal uptake; 1=focal areas affecting \<1% of skeleton; 2=focal areas affecting \>=5% of skeleton; 3=focal areas affecting \>=20% of skeleton; 4=focal areas affecting \>=50% of skeleton.
Outcome measures
| Measure |
Teriparatide
n=10 Participants
Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
|
|---|---|
|
Change in Qualitative Visual Scores of Focal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton
focal change, baseline to 3 months, n=10
|
0.1 units on a scale
Standard Deviation 0.32 • Interval 0.0 to 0.0
|
|
Change in Qualitative Visual Scores of Focal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton
focal change, baseline to 18 months, n=10
|
0.1 units on a scale
Standard Deviation 0.32 • Interval 0.0 to 0.0
|
|
Change in Qualitative Visual Scores of Focal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton
focal change, baseline to 24 months, n=9
|
0 units on a scale
Standard Deviation 0 • Interval 0.0 to 0.0
|
|
Change in Qualitative Visual Scores of Focal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton
focal change, 3 months to 18 months, n=10
|
0 units on a scale
Standard Deviation 0 • Interval 0.0 to 0.0
|
|
Change in Qualitative Visual Scores of Focal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton
focal change, 18 months to 24 months, n=9
|
0 units on a scale
Standard Deviation 0 • Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: baseline, 3 months, 18 months, 24 monthsPopulation: All participants with a baseline observation and at least 1 post-baseline observation.
Changes in diffuse uptake were determined by comparing diffuse uptake to baseline or other post-baseline observations. Diffuse uptake indicates response to therapy (during active treatment, increased diffuse uptake was expected; after the 6-month withdrawal period, decreased diffuse uptake was expected). Qualitative visual scoring of changes in the bone scan images were performed jointly by 3 reviewers who classified changes in the whole skeleton into 4 groups as follows: possible decreased response, no response, possible response, and definite response.
Outcome measures
| Measure |
Teriparatide
n=10 Participants
Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
|
|---|---|
|
Number of Participants With Changes in Diffuse Uptake of 99m Tc-MDP - Qualitative Visual Assessment in the Whole Skeleton
3 months, no response
|
2 participants
|
|
Number of Participants With Changes in Diffuse Uptake of 99m Tc-MDP - Qualitative Visual Assessment in the Whole Skeleton
3 months, possible response
|
2 participants
|
|
Number of Participants With Changes in Diffuse Uptake of 99m Tc-MDP - Qualitative Visual Assessment in the Whole Skeleton
3 months, definite response
|
6 participants
|
|
Number of Participants With Changes in Diffuse Uptake of 99m Tc-MDP - Qualitative Visual Assessment in the Whole Skeleton
18 months, no response
|
1 participants
|
|
Number of Participants With Changes in Diffuse Uptake of 99m Tc-MDP - Qualitative Visual Assessment in the Whole Skeleton
18 months, possible response
|
1 participants
|
|
Number of Participants With Changes in Diffuse Uptake of 99m Tc-MDP - Qualitative Visual Assessment in the Whole Skeleton
18 months, definite response
|
8 participants
|
|
Number of Participants With Changes in Diffuse Uptake of 99m Tc-MDP - Qualitative Visual Assessment in the Whole Skeleton
24 months, possible response
|
1 participants
|
|
Number of Participants With Changes in Diffuse Uptake of 99m Tc-MDP - Qualitative Visual Assessment in the Whole Skeleton
24 months, no response
|
6 participants
|
|
Number of Participants With Changes in Diffuse Uptake of 99m Tc-MDP - Qualitative Visual Assessment in the Whole Skeleton
24 months, definite response
|
1 participants
|
Adverse Events
Teriparatide
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Teriparatide
n=12 participants at risk
Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
|
|---|---|
|
General disorders
Chest pain
|
8.3%
1/12 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
8.3%
1/12 • Number of events 1
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
8.3%
1/12 • Number of events 1
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
8.3%
1/12 • Number of events 1
|
Other adverse events
| Measure |
Teriparatide
n=12 participants at risk
Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
|
|---|---|
|
Cardiac disorders
Arrhythmia
|
16.7%
2/12 • Number of events 3
|
|
Cardiac disorders
Palpitations
|
8.3%
1/12 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
8.3%
1/12 • Number of events 1
|
|
Ear and labyrinth disorders
Ear disorder
|
8.3%
1/12 • Number of events 1
|
|
Ear and labyrinth disorders
Eustachian tube obstruction
|
8.3%
1/12 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
16.7%
2/12 • Number of events 2
|
|
Ear and labyrinth disorders
Vertigo
|
8.3%
1/12 • Number of events 2
|
|
Eye disorders
Blepharitis
|
8.3%
1/12 • Number of events 1
|
|
Eye disorders
Cataract
|
8.3%
1/12 • Number of events 1
|
|
Eye disorders
Chorioretinal disorder
|
8.3%
1/12 • Number of events 1
|
|
Eye disorders
Optic atrophy
|
8.3%
1/12 • Number of events 1
|
|
Eye disorders
Vision blurred
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
16.7%
2/12 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal distension
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
2/12 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
16.7%
2/12 • Number of events 3
|
|
Gastrointestinal disorders
Haemorrhoids
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Hiatus hernia
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Inguinal hernia
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Lip disorder
|
8.3%
1/12 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
25.0%
3/12 • Number of events 4
|
|
General disorders
Chest pain
|
16.7%
2/12 • Number of events 2
|
|
General disorders
Cyst
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Fatigue
|
16.7%
2/12 • Number of events 2
|
|
General disorders
Feeling hot
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Injection site erythema
|
8.3%
1/12 • Number of events 2
|
|
General disorders
Injection site haematoma
|
8.3%
1/12 • Number of events 3
|
|
General disorders
Injection site irritation
|
8.3%
1/12 • Number of events 2
|
|
General disorders
Non-cardiac chest pain
|
8.3%
1/12 • Number of events 1
|
|
General disorders
Pain
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Eye infection
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Herpes zoster
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Influenza
|
16.7%
2/12 • Number of events 3
|
|
Infections and infestations
Kidney infection
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
1/12 • Number of events 1
|
|
Infections and infestations
Sinusitis
|
16.7%
2/12 • Number of events 2
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
2/12 • Number of events 2
|
|
Injury, poisoning and procedural complications
Contusion
|
8.3%
1/12 • Number of events 2
|
|
Injury, poisoning and procedural complications
Fall
|
8.3%
1/12 • Number of events 1
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
8.3%
1/12 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
8.3%
1/12 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fracture
|
8.3%
1/12 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fractured coccyx
|
8.3%
1/12 • Number of events 1
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
8.3%
1/12 • Number of events 1
|
|
Investigations
Blood pressure increased
|
16.7%
2/12 • Number of events 2
|
|
Investigations
Cardiac murmur
|
8.3%
1/12 • Number of events 1
|
|
Investigations
Weight increased
|
8.3%
1/12 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
8.3%
1/12 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
2/12 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
3/12 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
25.0%
3/12 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
8.3%
1/12 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Facet joint syndrome
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc space narrowing
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
2/12 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.7%
2/12 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Osteitis deformans
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Soft tissue disorder
|
8.3%
1/12 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
16.7%
2/12 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
8.3%
1/12 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • Number of events 2
|
|
Nervous system disorders
Extensor plantar response
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • Number of events 3
|
|
Nervous system disorders
Lethargy
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Migraine
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Nerve compression
|
16.7%
2/12 • Number of events 2
|
|
Nervous system disorders
Paraesthesia
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
16.7%
2/12 • Number of events 2
|
|
Nervous system disorders
Syncope
|
8.3%
1/12 • Number of events 1
|
|
Nervous system disorders
Transient ischaemic attack
|
8.3%
1/12 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12 • Number of events 1
|
|
Psychiatric disorders
Depression
|
8.3%
1/12 • Number of events 1
|
|
Renal and urinary disorders
Micturition urgency
|
8.3%
1/12 • Number of events 1
|
|
Renal and urinary disorders
Renal cyst
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.3%
1/12 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
8.3%
1/12 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
8.3%
1/12 • Number of events 1
|
|
Vascular disorders
Aortic stenosis
|
8.3%
1/12 • Number of events 1
|
|
Vascular disorders
Hypertension
|
16.7%
2/12 • Number of events 2
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60