Trial Outcomes & Findings for A Study for the Transdermal Application of Teriparatide (NCT NCT01011556)
NCT ID: NCT01011556
Last Updated: 2012-10-23
Results Overview
Bone mineral density (BMD) of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). Analyses were performed using ANCOVA model and least square (LS) means were adjusted for baseline BMD values as a covariate and pooled site and treatment as fixed effects.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
233 participants
Primary outcome timeframe
Baseline, 12 Months
Results posted on
2012-10-23
Participant Flow
Participant milestones
| Measure |
20 Mcg Subcutaneous Teriparatide
Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
|
30 Mcg Transdermal Teriparatide
Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
50 Mcg Transdermal Teriparatide
Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
80 Mcg Transdermal Teriparatide
Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
58
|
56
|
55
|
64
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
57
|
56
|
54
|
64
|
|
Overall Study
COMPLETED
|
52
|
48
|
45
|
51
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
10
|
13
|
Reasons for withdrawal
| Measure |
20 Mcg Subcutaneous Teriparatide
Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
|
30 Mcg Transdermal Teriparatide
Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
50 Mcg Transdermal Teriparatide
Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
80 Mcg Transdermal Teriparatide
Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
4
|
4
|
|
Overall Study
Sponsor decision
|
0
|
1
|
1
|
2
|
|
Overall Study
Inclusion/exclusion criteria not met
|
2
|
1
|
3
|
5
|
Baseline Characteristics
A Study for the Transdermal Application of Teriparatide
Baseline characteristics by cohort
| Measure |
20 Mcg Subcutaneous Teriparatide
n=57 Participants
Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
|
30 Mcg Transdermal Teriparatide
n=56 Participants
Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
50 Mcg Transdermal Teriparatide
n=54 Participants
Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
80 Mcg Transdermal Teriparatide
n=64 Participants
Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
Total
n=231 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age Continuous
|
63.9 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
65.0 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
67.6 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
65.1 years
STANDARD_DEVIATION 7.2 • n=4 Participants
|
65.4 years
STANDARD_DEVIATION 7.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
231 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
14 participants
n=5 Participants
|
15 participants
n=7 Participants
|
14 participants
n=5 Participants
|
17 participants
n=4 Participants
|
60 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Latin American
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Mexican
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
5 participants
n=5 Participants
|
6 participants
n=4 Participants
|
24 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
33 participants
n=5 Participants
|
32 participants
n=7 Participants
|
32 participants
n=5 Participants
|
40 participants
n=4 Participants
|
137 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
South American
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Spaniard
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
4 participants
n=21 Participants
|
|
Region of Enrollment
Estonia
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
4 participants
n=4 Participants
|
15 participants
n=21 Participants
|
|
Region of Enrollment
Hungary
|
21 participants
n=5 Participants
|
25 participants
n=7 Participants
|
23 participants
n=5 Participants
|
25 participants
n=4 Participants
|
94 participants
n=21 Participants
|
|
Region of Enrollment
Mexico
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
5 participants
n=5 Participants
|
6 participants
n=4 Participants
|
24 participants
n=21 Participants
|
|
Region of Enrollment
Argentina
|
17 participants
n=5 Participants
|
17 participants
n=7 Participants
|
16 participants
n=5 Participants
|
18 participants
n=4 Participants
|
68 participants
n=21 Participants
|
|
Region of Enrollment
Romania
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
4 participants
n=5 Participants
|
11 participants
n=4 Participants
|
30 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 MonthsPopulation: All participants who received at least 1 dose of drug and had at least 1 baseline and post-baseline lumbar spine BMD measure. Analysis was performed using intention-to-treat (ITT) principle, last observation carried forward method and ANCOVA model.
Bone mineral density (BMD) of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). Analyses were performed using ANCOVA model and least square (LS) means were adjusted for baseline BMD values as a covariate and pooled site and treatment as fixed effects.
Outcome measures
| Measure |
20 Mcg Subcutaneous Teriparatide
n=54 Participants
Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.
|
30 Mcg Transdermal Teriparatide
n=54 Participants
Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
50 Mcg Transdermal Teriparatide
n=51 Participants
Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
80 Mcg Transdermal Teriparatide
n=60 Participants
Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months
|
7.80 percentage change in BMD
Interval 6.867 to 8.73
|
0.63 percentage change in BMD
Interval -0.321 to 1.578
|
0.32 percentage change in BMD
Interval -0.657 to 1.287
|
1.63 percentage change in BMD
Interval 0.739 to 2.519
|
SECONDARY outcome
Timeframe: Baseline, 6 MonthsPopulation: All participants who received at least 1 dose of drug and had at least 1 baseline and post-baseline lumbar spine BMD measure. Analysis was performed using intent-to-treat principal, last observation carried forward method and ANCOVA model.
Bone mineral density (BMD) of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). Analyses were performed using ANCOVA model with the baseline value as a covariate and pooled site and treatment as fixed effects.
Outcome measures
| Measure |
20 Mcg Subcutaneous Teriparatide
n=54 Participants
Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.
|
30 Mcg Transdermal Teriparatide
n=52 Participants
Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
50 Mcg Transdermal Teriparatide
n=51 Participants
Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
80 Mcg Transdermal Teriparatide
n=58 Participants
Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 6 Months
|
4.74 percentage change in BMD
Interval 3.953 to 5.537
|
0.16 percentage change in BMD
Interval -0.661 to 0.983
|
0.88 percentage change in BMD
Interval 0.051 to 1.705
|
1.19 percentage change in BMD
Interval 0.418 to 1.957
|
SECONDARY outcome
Timeframe: Baseline to 6 Months and 12 MonthsPopulation: All participants who received at least 1 dose of drug, had at least 1 baseline and post-baseline lumbar spine BMD measure. Analysis was performed using ITT principal.
To assess the time course of the treatment, the BMD data of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA) and analyzed using a mixed model repeated measures (MMRM) method, with the repeated measure occurring at each visit (for example, 6 and 12 month). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar).
Outcome measures
| Measure |
20 Mcg Subcutaneous Teriparatide
n=57 Participants
Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.
|
30 Mcg Transdermal Teriparatide
n=56 Participants
Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
50 Mcg Transdermal Teriparatide
n=54 Participants
Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
80 Mcg Transdermal Teriparatide
n=63 Participants
Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
|---|---|---|---|---|
|
Time Course Change of BMD Response at the Lumbar Spine
12 months (n=52, 48, 45, 50)
|
8.12 percentage change in BMD
Interval 7.181 to 9.06
|
0.62 percentage change in BMD
Interval -0.367 to 1.601
|
0.66 percentage change in BMD
Interval -0.348 to 1.663
|
1.93 percentage change in BMD
Interval 0.989 to 2.881
|
|
Time Course Change of BMD Response at the Lumbar Spine
6 months (n=54, 52, 51, 58)
|
4.72 percentage change in BMD
Interval 3.927 to 5.516
|
0.19 percentage change in BMD
Interval -0.63 to 1.019
|
0.78 percentage change in BMD
Interval -0.05 to 1.606
|
1.19 percentage change in BMD
Interval 0.421 to 1.965
|
SECONDARY outcome
Timeframe: Baseline, 1 Month, 3 Months, 6 Months, 12 MonthsPopulation: All randomized participants who received at least one dose of study drug. The intent-to-treat principle was applied.
Procollagen Type 1 N-Terminal Propeptide (P1NP) is a marker of bone formation.
Outcome measures
| Measure |
20 Mcg Subcutaneous Teriparatide
n=52 Participants
Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.
|
30 Mcg Transdermal Teriparatide
n=53 Participants
Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
50 Mcg Transdermal Teriparatide
n=51 Participants
Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
80 Mcg Transdermal Teriparatide
n=62 Participants
Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP)
1 month (n=49, 53, 49, 60)
|
112.47 percentage change in P1NP
Standard Deviation 65.390
|
19.29 percentage change in P1NP
Standard Deviation 35.274
|
27.78 percentage change in P1NP
Standard Deviation 31.064
|
42.06 percentage change in P1NP
Standard Deviation 53.000
|
|
Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP)
3 months (n=50, 51, 49, 59)
|
174.88 percentage change in P1NP
Standard Deviation 118.745
|
35.68 percentage change in P1NP
Standard Deviation 50.358
|
53.53 percentage change in P1NP
Standard Deviation 64.625
|
116.34 percentage change in P1NP
Standard Deviation 117.697
|
|
Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP)
6 months (n=48, 49, 48, 56)
|
284.89 percentage change in P1NP
Standard Deviation 228.773
|
62.99 percentage change in P1NP
Standard Deviation 78.579
|
93.82 percentage change in P1NP
Standard Deviation 93.575
|
221.28 percentage change in P1NP
Standard Deviation 233.297
|
|
Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP)
12 months (n=47, 46, 43, 49)
|
232.41 percentage change in P1NP
Standard Deviation 176.557
|
72.17 percentage change in P1NP
Standard Deviation 86.747
|
97.14 percentage change in P1NP
Standard Deviation 98.007
|
178.02 percentage change in P1NP
Standard Deviation 181.361
|
SECONDARY outcome
Timeframe: Baseline, 1 Month, 3 Months, 6 Months, 12 MonthsPopulation: All randomized participants who received at least one dose of study drug. The intent-to-treat principle was applied.
C-terminal telopeptide is a marker of bone resorption.
Outcome measures
| Measure |
20 Mcg Subcutaneous Teriparatide
n=52 Participants
Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.
|
30 Mcg Transdermal Teriparatide
n=53 Participants
Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
50 Mcg Transdermal Teriparatide
n=51 Participants
Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
80 Mcg Transdermal Teriparatide
n=62 Participants
Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
|---|---|---|---|---|
|
Percent Change From Baseline of C-Terminal Telopeptide (CTX)
1 month (n=49, 53, 49, 60)
|
20.57 percentage change in CTX
Standard Deviation 64.980
|
8.05 percentage change in CTX
Standard Deviation 26.070
|
13.35 percentage change in CTX
Standard Deviation 29.384
|
21.66 percentage change in CTX
Standard Deviation 46.572
|
|
Percent Change From Baseline of C-Terminal Telopeptide (CTX)
3 months (n=50, 51, 49, 59)
|
87.78 percentage change in CTX
Standard Deviation 96.777
|
30.66 percentage change in CTX
Standard Deviation 42.048
|
42.40 percentage change in CTX
Standard Deviation 58.620
|
90.36 percentage change in CTX
Standard Deviation 103.367
|
|
Percent Change From Baseline of C-Terminal Telopeptide (CTX)
6 months (n=48, 49, 48, 56)
|
123.36 percentage change in CTX
Standard Deviation 128.832
|
37.36 percentage change in CTX
Standard Deviation 52.875
|
68.63 percentage change in CTX
Standard Deviation 71.059
|
127.81 percentage change in CTX
Standard Deviation 152.725
|
|
Percent Change From Baseline of C-Terminal Telopeptide (CTX)
12 months (n=47, 46, 43, 49)
|
97.52 percentage change in CTX
Standard Deviation 109.981
|
37.75 percentage change in CTX
Standard Deviation 58.035
|
61.25 percentage change in CTX
Standard Deviation 60.862
|
114.11 percentage change in CTX
Standard Deviation 157.485
|
SECONDARY outcome
Timeframe: Baseline, 1 MonthPopulation: All randomized participants who received at least one dose of study drug. The intent-to-treat principle was applied.
Procollagen Type 1 N-Terminal Propeptide (P1NP) is a marker of bone formation.
Outcome measures
| Measure |
20 Mcg Subcutaneous Teriparatide
n=49 Participants
Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.
|
30 Mcg Transdermal Teriparatide
n=53 Participants
Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
50 Mcg Transdermal Teriparatide
n=48 Participants
Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
80 Mcg Transdermal Teriparatide
n=59 Participants
Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
|---|---|---|---|---|
|
Percent Change From Baseline in Serum Procollagen Type 1 C-Propeptide (P1CP) at 1 Month
|
80.10 percentage change in P1CP
Standard Deviation 85.421
|
4.63 percentage change in P1CP
Standard Deviation 29.694
|
12.30 percentage change in P1CP
Standard Deviation 30.153
|
23.84 percentage change in P1CP
Standard Deviation 44.813
|
SECONDARY outcome
Timeframe: baseline up to 12 monthsPopulation: All randomized participants who received at least 1 dose of study drug and had CEUQ assessment. Last observation was carried forward, unless the last observation was also the first completed questionnaire.
CEUQ consists of 5 sections and 16 questions using a 5-point Likert scale designed to collect measures for ease of use (S1), convenience of use (S2), confidence of use (S3), fear of use (S4), and overall satisfaction with therapy (S5). CEUQ is not a validated instrument.
Outcome measures
| Measure |
20 Mcg Subcutaneous Teriparatide
n=55 Participants
Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.
|
30 Mcg Transdermal Teriparatide
n=54 Participants
Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
50 Mcg Transdermal Teriparatide
n=51 Participants
Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
80 Mcg Transdermal Teriparatide
n=62 Participants
Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
|---|---|---|---|---|
|
Convenience/Ease of Use Questionnaire (CEUQ)
S3-Not Confident
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Convenience/Ease of Use Questionnaire (CEUQ)
S3-Somewhat Not Confident
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Convenience/Ease of Use Questionnaire (CEUQ)
S4-Extremely Fearful
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Convenience/Ease of Use Questionnaire (CEUQ)
S4-Somewhat Not Fearful
|
9 participants
|
16 participants
|
9 participants
|
13 participants
|
|
Convenience/Ease of Use Questionnaire (CEUQ)
S5-Neutral
|
1 participants
|
0 participants
|
2 participants
|
1 participants
|
|
Convenience/Ease of Use Questionnaire (CEUQ)
S5-Somewhat Satisfied
|
10 participants
|
13 participants
|
10 participants
|
18 participants
|
|
Convenience/Ease of Use Questionnaire (CEUQ)
S5-Very Satisfied
|
44 participants
|
40 participants
|
38 participants
|
43 participants
|
|
Convenience/Ease of Use Questionnaire (CEUQ)
S1-Stronly Disagree
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Convenience/Ease of Use Questionnaire (CEUQ)
S1-Somewhat Disagree
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Convenience/Ease of Use Questionnaire (CEUQ)
S1-Neutral
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Convenience/Ease of Use Questionnaire (CEUQ)
S1-Somewhat Agree
|
11 participants
|
9 participants
|
8 participants
|
10 participants
|
|
Convenience/Ease of Use Questionnaire (CEUQ)
S1-Strongly Agree
|
44 participants
|
45 participants
|
42 participants
|
52 participants
|
|
Convenience/Ease of Use Questionnaire (CEUQ)
S2-Strongly Disagree
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Convenience/Ease of Use Questionnaire (CEUQ)
S2-Somewhat Disagree
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Convenience/Ease of Use Questionnaire (CEUQ)
S2-Neutral
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Convenience/Ease of Use Questionnaire (CEUQ)
S2-Somewhat Agree
|
11 participants
|
12 participants
|
9 participants
|
12 participants
|
|
Convenience/Ease of Use Questionnaire (CEUQ)
S2-Strongly Agree
|
43 participants
|
41 participants
|
41 participants
|
50 participants
|
|
Convenience/Ease of Use Questionnaire (CEUQ)
S3-Neutral
|
0 participants
|
0 participants
|
3 participants
|
4 participants
|
|
Convenience/Ease of Use Questionnaire (CEUQ)
S3-Somewhat Confident
|
13 participants
|
15 participants
|
11 participants
|
17 participants
|
|
Convenience/Ease of Use Questionnaire (CEUQ)
S3-Very Confident
|
42 participants
|
38 participants
|
36 participants
|
40 participants
|
|
Convenience/Ease of Use Questionnaire (CEUQ)
S4-Somewhat Fearful
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Convenience/Ease of Use Questionnaire (CEUQ)
S4-Neutral
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Convenience/Ease of Use Questionnaire (CEUQ)
S4-Not Fearful
|
44 participants
|
37 participants
|
40 participants
|
48 participants
|
|
Convenience/Ease of Use Questionnaire (CEUQ)
S5-Very Dissatisfied
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Convenience/Ease of Use Questionnaire (CEUQ)
S5-Somewhat Dissatisfied
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, 12 MonthsPopulation: All randomized participants who received at least 1 dose of study drug and had serum calcium measurements or adjusted serum calcium measurements at the indicated timepoint.
Serum calcium adjusted for serum albumin levels is calculated using the following formula: Total Calcium + \[(40 - albumin) x 0.02\]. Analysis for serum calcium and albumin adjusted serum calcium were collected at predose, 4 hours (h) post-dose (PD) and 6 h PD at baseline and 12 months (mon).
Outcome measures
| Measure |
20 Mcg Subcutaneous Teriparatide
n=57 Participants
Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.
|
30 Mcg Transdermal Teriparatide
n=56 Participants
Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
50 Mcg Transdermal Teriparatide
n=54 Participants
Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
80 Mcg Transdermal Teriparatide
n=64 Participants
Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
|---|---|---|---|---|
|
Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours
12 mon-predose; no adjustment (n=52,47,45,50)
|
2.463 millimole/Liter (mmol/L)
Standard Deviation 0.1243
|
2.427 millimole/Liter (mmol/L)
Standard Deviation 0.0977
|
2.427 millimole/Liter (mmol/L)
Standard Deviation 0.0842
|
2.432 millimole/Liter (mmol/L)
Standard Deviation 0.0937
|
|
Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours
12 mon-4 h PD; no adjustment (n=51,46,44,51)
|
2.516 millimole/Liter (mmol/L)
Standard Deviation 0.1815
|
2.428 millimole/Liter (mmol/L)
Standard Deviation 0.1024
|
2.430 millimole/Liter (mmol/L)
Standard Deviation 0.1199
|
2.464 millimole/Liter (mmol/L)
Standard Deviation 0.1042
|
|
Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours
12 mon-6 h PD; no adjustment (n=50,45,44,51)
|
2.532 millimole/Liter (mmol/L)
Standard Deviation 0.1429
|
2.426 millimole/Liter (mmol/L)
Standard Deviation 0.0866
|
2.443 millimole/Liter (mmol/L)
Standard Deviation 0.0997
|
2.467 millimole/Liter (mmol/L)
Standard Deviation 0.0959
|
|
Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours
Baseline- predose; no adjustment (n=54,53,51,62)
|
2.391 millimole/Liter (mmol/L)
Standard Deviation 0.0776
|
2.362 millimole/Liter (mmol/L)
Standard Deviation 0.0933
|
2.389 millimole/Liter (mmol/L)
Standard Deviation 0.0921
|
2.392 millimole/Liter (mmol/L)
Standard Deviation 0.0915
|
|
Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours
Baseline- 4 h PD; no adjustment (n=55,53,51,63)
|
2.432 millimole/Liter (mmol/L)
Standard Deviation 0.1191
|
2.358 millimole/Liter (mmol/L)
Standard Deviation 0.1315
|
2.403 millimole/Liter (mmol/L)
Standard Deviation 0.1160
|
2.393 millimole/Liter (mmol/L)
Standard Deviation 0.1113
|
|
Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours
Baseline- 6 h PD; no adjustment (n=52,51,48,59)
|
2.440 millimole/Liter (mmol/L)
Standard Deviation 0.1159
|
2.369 millimole/Liter (mmol/L)
Standard Deviation 0.0789
|
2.400 millimole/Liter (mmol/L)
Standard Deviation 0.1167
|
2.397 millimole/Liter (mmol/L)
Standard Deviation 0.1048
|
|
Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours
baseline-predose albumin adjusted (n=53,53,50,60)
|
2.363 millimole/Liter (mmol/L)
Standard Deviation 0.0811
|
2.341 millimole/Liter (mmol/L)
Standard Deviation 0.0949
|
2.376 millimole/Liter (mmol/L)
Standard Deviation 0.0807
|
2.373 millimole/Liter (mmol/L)
Standard Deviation 0.0809
|
|
Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours
baseline-4 h PD; albumin adjusted (n=52,52,50,61)
|
2.418 millimole/Liter (mmol/L)
Standard Deviation 0.1099
|
2.348 millimole/Liter (mmol/L)
Standard Deviation 0.1283
|
2.403 millimole/Liter (mmol/L)
Standard Deviation 0.0928
|
2.386 millimole/Liter (mmol/L)
Standard Deviation 0.1045
|
|
Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours
baseline-6 h PD; albumin adjusted (n=49,50,47,57)
|
2.423 millimole/Liter (mmol/L)
Standard Deviation 0.1100
|
2.363 millimole/Liter (mmol/L)
Standard Deviation 0.0727
|
2.404 millimole/Liter (mmol/L)
Standard Deviation 0.0908
|
2.394 millimole/Liter (mmol/L)
Standard Deviation 0.0934
|
|
Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours
12 mon- predose albumin adjusted (n=52,47,45,50)
|
2.461 millimole/Liter (mmol/L)
Standard Deviation 0.0998
|
2.432 millimole/Liter (mmol/L)
Standard Deviation 0.0806
|
2.449 millimole/Liter (mmol/L)
Standard Deviation 0.0861
|
2.442 millimole/Liter (mmol/L)
Standard Deviation 0.0840
|
|
Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours
12 mon- 4 h PD; albumin adjusted (n=51,46,44,51)
|
2.523 millimole/Liter (mmol/L)
Standard Deviation 0.1680
|
2.438 millimole/Liter (mmol/L)
Standard Deviation 0.1022
|
2.458 millimole/Liter (mmol/L)
Standard Deviation 0.1012
|
2.482 millimole/Liter (mmol/L)
Standard Deviation 0.0962
|
|
Change in Serum Calcium With and Without Adjustments for Serum Albumin From Predose to After 4 and 6 Hours
12 mon-6 h PD; albumin adjusted (n=52,47,45,50)
|
2.547 millimole/Liter (mmol/L)
Standard Deviation 0.1236
|
2.443 millimole/Liter (mmol/L)
Standard Deviation 0.0838
|
2.481 millimole/Liter (mmol/L)
Standard Deviation 0.1044
|
2.483 millimole/Liter (mmol/L)
Standard Deviation 0.1348
|
SECONDARY outcome
Timeframe: Baseline, 6 Months, 12 MonthsPopulation: All randomized participants who received at least 1 dose of study drug and had urine calcium measurements at the indicated timepoint.
Outcome measures
| Measure |
20 Mcg Subcutaneous Teriparatide
n=57 Participants
Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.
|
30 Mcg Transdermal Teriparatide
n=56 Participants
Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
50 Mcg Transdermal Teriparatide
n=54 Participants
Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
80 Mcg Transdermal Teriparatide
n=64 Participants
Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
|---|---|---|---|---|
|
Change From Baseline in Urine Calcium Excretion at 6 and 12 Months
Baseline
|
4.45 millimole/day (mmol/day)
Standard Deviation 1.851
|
4.21 millimole/day (mmol/day)
Standard Deviation 1.766
|
4.26 millimole/day (mmol/day)
Standard Deviation 1.673
|
4.24 millimole/day (mmol/day)
Standard Deviation 1.876
|
|
Change From Baseline in Urine Calcium Excretion at 6 and 12 Months
6 months (n=54, 50, 49, 56)
|
2.02 millimole/day (mmol/day)
Standard Deviation 4.122
|
0.70 millimole/day (mmol/day)
Standard Deviation 3.467
|
1.20 millimole/day (mmol/day)
Standard Deviation 2.768
|
1.35 millimole/day (mmol/day)
Standard Deviation 2.360
|
|
Change From Baseline in Urine Calcium Excretion at 6 and 12 Months
12 months (n=51, 47, 41, 51)
|
5.25 millimole/day (mmol/day)
Standard Deviation 3.694
|
4.97 millimole/day (mmol/day)
Standard Deviation 2.192
|
4.80 millimole/day (mmol/day)
Standard Deviation 2.738
|
4.51 millimole/day (mmol/day)
Standard Deviation 2.770
|
SECONDARY outcome
Timeframe: Pre-Dose, 30 minutes, 2 hours Post-Dose at Baseline and 12 MonthsPopulation: All randomized participants who received at least 1 dose of study drug and had predose and postdose blood pressure measurements at the indicated timepoint and body position.
Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) measured at pre-dose and 30 minutes (min) and 2 hours (hr) post-dose in both the supine and standing position.
Outcome measures
| Measure |
20 Mcg Subcutaneous Teriparatide
n=57 Participants
Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.
|
30 Mcg Transdermal Teriparatide
n=56 Participants
Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
50 Mcg Transdermal Teriparatide
n=54 Participants
Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
80 Mcg Transdermal Teriparatide
n=64 Participants
Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
|---|---|---|---|---|
|
Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon)
BL, supine, SBP, 30 min (n=56,54,51,62)
|
-0.6 mmHg
Standard Deviation 10.71
|
2.0 mmHg
Standard Deviation 10.25
|
-1.0 mmHg
Standard Deviation 11.59
|
-0.8 mmHg
Standard Deviation 10.77
|
|
Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon)
BL, supine, SBP, 2 h (n=56,56,53,63)
|
-0.3 mmHg
Standard Deviation 13.06
|
-0.9 mmHg
Standard Deviation 10.97
|
-3.5 mmHg
Standard Deviation 9.97
|
-0.6 mmHg
Standard Deviation 12.91
|
|
Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon)
BL, supine, DBP, 30 min (n=56,54,51,62)
|
-1.9 mmHg
Standard Deviation 7.63
|
1.4 mmHg
Standard Deviation 7.59
|
-2.5 mmHg
Standard Deviation 7.50
|
-1.1 mmHg
Standard Deviation 7.17
|
|
Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon)
BL, supine, DBP, 2 h (n=56,56,53,63)
|
-2.1 mmHg
Standard Deviation 7.59
|
-0.8 mmHg
Standard Deviation 8.51
|
-3.6 mmHg
Standard Deviation 7.02
|
-1.6 mmHg
Standard Deviation 7.67
|
|
Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon)
12mon, supine, SBP, 30min (n=51,47,44,51)
|
0.8 mmHg
Standard Deviation 8.52
|
-2.2 mmHg
Standard Deviation 7.47
|
-1.1 mmHg
Standard Deviation 8.87
|
-2.0 mmHg
Standard Deviation 9.82
|
|
Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon)
12mon, supine, SBP, 2 h (n=51,47,44,51)
|
-0.2 mmHg
Standard Deviation 10.71
|
-1.8 mmHg
Standard Deviation 11.19
|
-2.5 mmHg
Standard Deviation 9.54
|
-1.9 mmHg
Standard Deviation 10.87
|
|
Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon)
12mon, supine, DBP, 30min (n=52,48,45,51)
|
-1.8 mmHg
Standard Deviation 7.14
|
-1.8 mmHg
Standard Deviation 6.08
|
-2.1 mmHg
Standard Deviation 6.77
|
-1.2 mmHg
Standard Deviation 7.25
|
|
Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon)
12mon, supine, DBP, 2 h (n=51,47,44,51)
|
-1.3 mmHg
Standard Deviation 6.94
|
-3.3 mmHg
Standard Deviation 7.79
|
-1.3 mmHg
Standard Deviation 6.79
|
-2.0 mmHg
Standard Deviation 8.59
|
|
Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon)
BL, standing, SBP, 30 min (n=56,54,51,62)
|
-1.3 mmHg
Standard Deviation 9.38
|
2.5 mmHg
Standard Deviation 8.93
|
-0.6 mmHg
Standard Deviation 10.65
|
-0.5 mmHg
Standard Deviation 10.04
|
|
Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon)
BL, standing, SBP, 2 h (n=56,56,53,64)
|
-1.7 mmHg
Standard Deviation 11.57
|
-1.6 mmHg
Standard Deviation 11.03
|
-3.8 mmHg
Standard Deviation 10.96
|
0.0 mmHg
Standard Deviation 12.11
|
|
Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon)
BL, standing, DBP, 30 min (n=56,54,51,62)
|
-2.3 mmHg
Standard Deviation 6.56
|
0.2 mmHg
Standard Deviation 8.18
|
-1.2 mmHg
Standard Deviation 8.34
|
-1.2 mmHg
Standard Deviation 7.80
|
|
Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon)
BL, standing, DBP, 2 h (n=56,56,53,64)
|
-2.3 mmHg
Standard Deviation 7.55
|
-2.1 mmHg
Standard Deviation 7.80
|
-1.1 mmHg
Standard Deviation 7.25
|
-1.7 mmHg
Standard Deviation 8.84
|
|
Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon)
12mon, standing, SBP, 30min(n=51,47,44,51)
|
-0.6 mmHg
Standard Deviation 10.55
|
-0.9 mmHg
Standard Deviation 8.41
|
0.5 mmHg
Standard Deviation 8.68
|
-0.8 mmHg
Standard Deviation 8.72
|
|
Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon)
12mon, standing, SBP, 2 h (n=51,47,44,51)
|
-0.1 mmHg
Standard Deviation 11.86
|
-0.4 mmHg
Standard Deviation 7.64
|
-1.3 mmHg
Standard Deviation 12.97
|
-0.9 mmHg
Standard Deviation 10.24
|
|
Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon)
12mon, standing, DBP, 30 min(n=51,47,44,51
|
-1.8 mmHg
Standard Deviation 7.12
|
-2.4 mmHg
Standard Deviation 6.04
|
-3.5 mmHg
Standard Deviation 8.09
|
1.4 mmHg
Standard Deviation 7.75
|
|
Change From Pre-dose and Postdose Supine and Standing SBP and DBP at Baseline (BL) and 12 Months (Mon)
12mon, standing, DBP, 2 h (n=51,47,44,51)
|
1.1 mmHg
Standard Deviation 6.93
|
-2.0 mmHg
Standard Deviation 7.35
|
-1.9 mmHg
Standard Deviation 7.70
|
0.1 mmHg
Standard Deviation 7.44
|
SECONDARY outcome
Timeframe: Pre-dose, 30 minutes, 2 hours at Baseline and 12 MonthsPopulation: All randomized participants who received at least 1 dose of study drug and had predose and postdose heart rate measurements at the indicated timepoint and body position.
Outcome measures
| Measure |
20 Mcg Subcutaneous Teriparatide
n=57 Participants
Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.
|
30 Mcg Transdermal Teriparatide
n=56 Participants
Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
50 Mcg Transdermal Teriparatide
n=54 Participants
Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
80 Mcg Transdermal Teriparatide
n=64 Participants
Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
|---|---|---|---|---|
|
Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon).
BL, supine, 30 min (n=56,54,51,62)
|
1.8 beats per minute (bpm)
Standard Deviation 5.66
|
1.7 beats per minute (bpm)
Standard Deviation 5.96
|
-0.8 beats per minute (bpm)
Standard Deviation 7.21
|
-0.6 beats per minute (bpm)
Standard Deviation 6.50
|
|
Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon).
BL, supine, 2 h (n=56,56,53,63)
|
1.5 beats per minute (bpm)
Standard Deviation 8.01
|
0.9 beats per minute (bpm)
Standard Deviation 5.61
|
-0.8 beats per minute (bpm)
Standard Deviation 8.49
|
-0.4 beats per minute (bpm)
Standard Deviation 6.90
|
|
Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon).
BL, standing, 30 min (n=56,54,51,62)
|
1.6 beats per minute (bpm)
Standard Deviation 6.41
|
-1.0 beats per minute (bpm)
Standard Deviation 7.36
|
0.7 beats per minute (bpm)
Standard Deviation 6.68
|
-1.2 beats per minute (bpm)
Standard Deviation 7.61
|
|
Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon).
BL, standing, 2 h (n=56,56,53,64)
|
1.0 beats per minute (bpm)
Standard Deviation 8.03
|
-0.8 beats per minute (bpm)
Standard Deviation 8.51
|
0.5 beats per minute (bpm)
Standard Deviation 6.51
|
-1.0 beats per minute (bpm)
Standard Deviation 8.05
|
|
Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon).
12 mon, supine, 30 min (n=51,47,44,51)
|
2.5 beats per minute (bpm)
Standard Deviation 4.81
|
1.4 beats per minute (bpm)
Standard Deviation 4.74
|
-0.1 beats per minute (bpm)
Standard Deviation 4.06
|
-0.2 beats per minute (bpm)
Standard Deviation 5.22
|
|
Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon).
12 mon, supine, 2 h (n=51,47,44,51)
|
1.6 beats per minute (bpm)
Standard Deviation 6.74
|
1.1 beats per minute (bpm)
Standard Deviation 6.60
|
-0.3 beats per minute (bpm)
Standard Deviation 5.43
|
-0.8 beats per minute (bpm)
Standard Deviation 6.69
|
|
Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon).
12 mon, standing, 30 min (n=51,47,44,51)
|
1.2 beats per minute (bpm)
Standard Deviation 7.35
|
0.0 beats per minute (bpm)
Standard Deviation 5.28
|
-0.7 beats per minute (bpm)
Standard Deviation 5.97
|
-0.4 beats per minute (bpm)
Standard Deviation 6.90
|
|
Change From Pre-dose to Postdose in Supine and Standing Heart Rate at Baseline (BL) and 12 Months (Mon).
12 mon, standing, 2 h (n=51,47,44,51)
|
0.9 beats per minute (bpm)
Standard Deviation 9.03
|
0.1 beats per minute (bpm)
Standard Deviation 7.36
|
-0.4 beats per minute (bpm)
Standard Deviation 7.03
|
-0.7 beats per minute (bpm)
Standard Deviation 7.72
|
SECONDARY outcome
Timeframe: Baseline and 1, 3, 12, and 13 Months (mon)Population: All randomized participants who received at least one dose of study drug and had antibody results.
Participants were tested for anti-recombinant teriparatide and anti-synthetic teriparatide titers. Either none were detected (ND) or antibodies were determined to be present if the teriparatide specific antibody titers were at least 1:8 (titer 1:8).
Outcome measures
| Measure |
20 Mcg Subcutaneous Teriparatide
n=57 Participants
Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.
|
30 Mcg Transdermal Teriparatide
n=56 Participants
Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
50 Mcg Transdermal Teriparatide
n=54 Participants
Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
80 Mcg Transdermal Teriparatide
n=64 Participants
Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
|---|---|---|---|---|
|
Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels
Baseline: anti-recombinant ND (n=57, 54, 53, 64)
|
57 participants
|
54 participants
|
52 participants
|
64 participants
|
|
Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels
Baseline:anti-recombinant titer 1:8(n=57,54,53,64)
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels
1 mon:anti-recombinant ND (n=54,54,51,62)
|
54 participants
|
54 participants
|
51 participants
|
62 participants
|
|
Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels
1 mon:anti-recombinant titer 1:8 (n=54,54,51,62
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels
3 mon:anti-recombinant ND (n=55,52,51,61)
|
55 participants
|
52 participants
|
50 participants
|
61 participants
|
|
Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels
3 mon:anti-recombinant titer 1:8 (n=55,52,51,6
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels
12 mon:anti-recombinant ND (n=52,48,45,51)
|
52 participants
|
48 participants
|
44 participants
|
51 participants
|
|
Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels
12 mon:anti-recombinant titer 1:8 (n=52,48,45,51)
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels
13 mon:anti-recombinant ND (n=50,46,44,50)
|
50 participants
|
46 participants
|
43 participants
|
50 participants
|
|
Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels
13 mon:anti-recombinant titer 1:8 (n=50,46,44,50)
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels
Baseline:anti-synthetic ND (n=57,54,53,64)
|
57 participants
|
54 participants
|
52 participants
|
64 participants
|
|
Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels
Baseline:anti-synthetic titer 1:8 (n=57,54,53,64)
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels
1 mon:anti-synthetic ND (N=54,54,51,62)
|
54 participants
|
54 participants
|
50 participants
|
62 participants
|
|
Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels
1 mon:anti-synthetic titer 1:8 (N=54,54,51,62)
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels
3 mon:anti-synthetic ND (n=55,52,51,61)
|
55 participants
|
52 participants
|
50 participants
|
61 participants
|
|
Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels
3 mon:anti-synthetic titer 1:8 (n=55,52,51,61)
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels
12 mon:anti-synthetic ND (n=52,48,45,51)
|
52 participants
|
48 participants
|
44 participants
|
51 participants
|
|
Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels
12 mon:anti-synthetic titer 18 (n=52,48,45,51)
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels
13 mon:anti-synthetic ND (n=50,46,44,50)
|
50 participants
|
46 participants
|
43 participants
|
50 participants
|
|
Number of Participants With Parathyroid Hormone (PTH) Specific Antibody Levels
13 mon:anti-synthetic titer 1:8 (n=50,46,44,50)
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, 1 Month, 3 Months, and 12 MonthsPopulation: Due to high intra-subject variability, zero participants were analyzed on this outcome measure.
Due to high intra-subject variability, data was not analyzed for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 1 Month, 3 Months, 12 MonthsPopulation: Due to high intra-subject variability, zero participants were analyzed for this outcome measure.
Due to high intra-subject variability, data was not analyzed for this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 13 Month follow-upPopulation: All randomized participants who received at least 1 dose of study drug and had edema measurements at 13 months.
Severity of edema was categorized based on a 5 point scale: 0=no edema, 4=severe edema (defined as an area raised more than 1 millimeter and extending beyond area of exposure)
Outcome measures
| Measure |
20 Mcg Subcutaneous Teriparatide
n=41 Participants
Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.
|
30 Mcg Transdermal Teriparatide
n=39 Participants
Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
50 Mcg Transdermal Teriparatide
n=39 Participants
Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
80 Mcg Transdermal Teriparatide
n=43 Participants
Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
|---|---|---|---|---|
|
DRAIZE Edema Assessment at Baseline Through 13 Month Follow-up
0=no edema
|
41 participants
|
39 participants
|
39 participants
|
43 participants
|
|
DRAIZE Edema Assessment at Baseline Through 13 Month Follow-up
1=very slight edema to 4=severe edema
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 13 Month follow-upPopulation: All randomized participants who received at least 1 dose of study drug and had erythema measurements at 13 months.
Severity of erythema was categorized based on a 5 point scale: 0=no erythema, 4=severe erythema (defined as beet red to eschar)
Outcome measures
| Measure |
20 Mcg Subcutaneous Teriparatide
n=41 Participants
Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.
|
30 Mcg Transdermal Teriparatide
n=39 Participants
Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
50 Mcg Transdermal Teriparatide
n=39 Participants
Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
80 Mcg Transdermal Teriparatide
n=43 Participants
Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
|---|---|---|---|---|
|
DRAIZE Erythema Assessment at Baseline Through 13 Month Follow-up
0=no erythema
|
41 participants
|
39 participants
|
39 participants
|
43 participants
|
|
DRAIZE Erythema Assessment at Baseline Through 13 Month Follow-up
1=very slight erythema to 4=severe erythema
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
20 Mcg Subcutaneous Teriparatide
Serious events: 2 serious events
Other events: 30 other events
Deaths: 0 deaths
30 Mcg Transdermal Teriparatide
Serious events: 2 serious events
Other events: 33 other events
Deaths: 0 deaths
50 Mcg Transdermal Teriparatide
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
80 Mcg Transdermal Teriparatide
Serious events: 5 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
20 Mcg Subcutaneous Teriparatide
n=57 participants at risk
Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
|
30 Mcg Transdermal Teriparatide
n=56 participants at risk
Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
50 Mcg Transdermal Teriparatide
n=54 participants at risk
Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
80 Mcg Transdermal Teriparatide
n=64 participants at risk
Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/57
|
0.00%
0/56
|
0.00%
0/54
|
1.6%
1/64 • Number of events 1
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/57
|
0.00%
0/56
|
0.00%
0/54
|
1.6%
1/64 • Number of events 1
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/57
|
0.00%
0/56
|
0.00%
0/54
|
1.6%
1/64 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/57
|
0.00%
0/56
|
0.00%
0/54
|
1.6%
1/64 • Number of events 1
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/57
|
1.8%
1/56 • Number of events 1
|
0.00%
0/54
|
0.00%
0/64
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/57
|
0.00%
0/56
|
0.00%
0/54
|
1.6%
1/64 • Number of events 1
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/57
|
0.00%
0/56
|
1.9%
1/54 • Number of events 1
|
0.00%
0/64
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/57
|
1.8%
1/56 • Number of events 2
|
0.00%
0/54
|
0.00%
0/64
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/57
|
0.00%
0/56
|
0.00%
0/54
|
1.6%
1/64 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
3.5%
2/57 • Number of events 2
|
0.00%
0/56
|
0.00%
0/54
|
0.00%
0/64
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/57
|
0.00%
0/56
|
0.00%
0/54
|
1.6%
1/64 • Number of events 1
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/57
|
0.00%
0/56
|
0.00%
0/54
|
1.6%
1/64 • Number of events 1
|
Other adverse events
| Measure |
20 Mcg Subcutaneous Teriparatide
n=57 participants at risk
Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
|
30 Mcg Transdermal Teriparatide
n=56 participants at risk
Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
50 Mcg Transdermal Teriparatide
n=54 participants at risk
Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
80 Mcg Transdermal Teriparatide
n=64 participants at risk
Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/57
|
3.6%
2/56 • Number of events 2
|
1.9%
1/54 • Number of events 1
|
0.00%
0/64
|
|
Ear and labyrinth disorders
Ear pain
|
3.5%
2/57 • Number of events 2
|
0.00%
0/56
|
1.9%
1/54 • Number of events 1
|
0.00%
0/64
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/57
|
3.6%
2/56 • Number of events 2
|
1.9%
1/54 • Number of events 1
|
0.00%
0/64
|
|
Eye disorders
Cataract
|
1.8%
1/57 • Number of events 1
|
1.8%
1/56 • Number of events 1
|
3.7%
2/54 • Number of events 2
|
0.00%
0/64
|
|
Eye disorders
Conjunctivitis
|
1.8%
1/57 • Number of events 1
|
3.6%
2/56 • Number of events 2
|
0.00%
0/54
|
1.6%
1/64 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
1.8%
1/57 • Number of events 1
|
0.00%
0/56
|
0.00%
0/54
|
3.1%
2/64 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/57
|
3.6%
2/56 • Number of events 2
|
0.00%
0/54
|
0.00%
0/64
|
|
Gastrointestinal disorders
Constipation
|
1.8%
1/57 • Number of events 1
|
1.8%
1/56 • Number of events 1
|
1.9%
1/54 • Number of events 2
|
3.1%
2/64 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
1/57 • Number of events 1
|
3.6%
2/56 • Number of events 2
|
3.7%
2/54 • Number of events 2
|
1.6%
1/64 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
3.5%
2/57 • Number of events 2
|
0.00%
0/56
|
0.00%
0/54
|
1.6%
1/64 • Number of events 2
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/57
|
0.00%
0/56
|
3.7%
2/54 • Number of events 2
|
0.00%
0/64
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/57
|
3.6%
2/56 • Number of events 2
|
0.00%
0/54
|
0.00%
0/64
|
|
Gastrointestinal disorders
Nausea
|
1.8%
1/57 • Number of events 1
|
0.00%
0/56
|
0.00%
0/54
|
6.2%
4/64 • Number of events 5
|
|
General disorders
Application site discolouration
|
0.00%
0/57
|
3.6%
2/56 • Number of events 2
|
1.9%
1/54 • Number of events 1
|
1.6%
1/64 • Number of events 1
|
|
Infections and infestations
Bronchitis
|
5.3%
3/57 • Number of events 4
|
1.8%
1/56 • Number of events 1
|
1.9%
1/54 • Number of events 1
|
3.1%
2/64 • Number of events 2
|
|
Infections and infestations
Cystitis
|
0.00%
0/57
|
0.00%
0/56
|
0.00%
0/54
|
3.1%
2/64 • Number of events 3
|
|
Infections and infestations
Gastroenteritis
|
1.8%
1/57 • Number of events 1
|
3.6%
2/56 • Number of events 2
|
1.9%
1/54 • Number of events 1
|
1.6%
1/64 • Number of events 1
|
|
Infections and infestations
Influenza
|
5.3%
3/57 • Number of events 3
|
5.4%
3/56 • Number of events 3
|
1.9%
1/54 • Number of events 1
|
7.8%
5/64 • Number of events 5
|
|
Infections and infestations
Nasopharyngitis
|
3.5%
2/57 • Number of events 2
|
0.00%
0/56
|
3.7%
2/54 • Number of events 2
|
1.6%
1/64 • Number of events 1
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/57
|
1.8%
1/56 • Number of events 1
|
3.7%
2/54 • Number of events 2
|
3.1%
2/64 • Number of events 2
|
|
Infections and infestations
Pneumonia
|
1.8%
1/57 • Number of events 1
|
0.00%
0/56
|
0.00%
0/54
|
3.1%
2/64 • Number of events 2
|
|
Infections and infestations
Urinary tract infection
|
5.3%
3/57 • Number of events 3
|
1.8%
1/56 • Number of events 1
|
3.7%
2/54 • Number of events 2
|
1.6%
1/64 • Number of events 1
|
|
Infections and infestations
Viral infection
|
3.5%
2/57 • Number of events 2
|
3.6%
2/56 • Number of events 2
|
1.9%
1/54 • Number of events 1
|
0.00%
0/64
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/57
|
0.00%
0/56
|
0.00%
0/54
|
3.1%
2/64 • Number of events 2
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/57
|
3.6%
2/56 • Number of events 2
|
0.00%
0/54
|
1.6%
1/64 • Number of events 1
|
|
Injury, poisoning and procedural complications
Radius fracture
|
7.0%
4/57 • Number of events 4
|
0.00%
0/56
|
0.00%
0/54
|
0.00%
0/64
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
5.3%
3/57 • Number of events 4
|
0.00%
0/56
|
0.00%
0/54
|
0.00%
0/64
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.8%
1/57 • Number of events 1
|
0.00%
0/56
|
0.00%
0/54
|
3.1%
2/64 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.8%
1/57 • Number of events 1
|
7.1%
4/56 • Number of events 4
|
1.9%
1/54 • Number of events 1
|
4.7%
3/64 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/57
|
1.8%
1/56 • Number of events 2
|
1.9%
1/54 • Number of events 2
|
4.7%
3/64 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.8%
1/57 • Number of events 1
|
0.00%
0/56
|
5.6%
3/54 • Number of events 3
|
3.1%
2/64 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.5%
2/57 • Number of events 2
|
1.8%
1/56 • Number of events 2
|
1.9%
1/54 • Number of events 1
|
0.00%
0/64
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.8%
1/57 • Number of events 2
|
1.8%
1/56 • Number of events 1
|
0.00%
0/54
|
3.1%
2/64 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/57
|
0.00%
0/56
|
3.7%
2/54 • Number of events 2
|
1.6%
1/64 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.8%
1/57 • Number of events 1
|
0.00%
0/56
|
1.9%
1/54 • Number of events 1
|
3.1%
2/64 • Number of events 2
|
|
Nervous system disorders
Paraesthesia
|
1.8%
1/57 • Number of events 1
|
1.8%
1/56 • Number of events 1
|
3.7%
2/54 • Number of events 2
|
0.00%
0/64
|
|
Nervous system disorders
Sciatica
|
0.00%
0/57
|
0.00%
0/56
|
0.00%
0/54
|
3.1%
2/64 • Number of events 2
|
|
Psychiatric disorders
Depression
|
1.8%
1/57 • Number of events 1
|
3.6%
2/56 • Number of events 2
|
3.7%
2/54 • Number of events 2
|
0.00%
0/64
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/57
|
0.00%
0/56
|
5.6%
3/54 • Number of events 3
|
0.00%
0/64
|
|
Renal and urinary disorders
Hypercalciuria
|
3.5%
2/57 • Number of events 2
|
1.8%
1/56 • Number of events 1
|
9.3%
5/54 • Number of events 5
|
9.4%
6/64 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/57
|
0.00%
0/56
|
3.7%
2/54 • Number of events 2
|
0.00%
0/64
|
|
Vascular disorders
Hypertension
|
3.5%
2/57 • Number of events 2
|
3.6%
2/56 • Number of events 2
|
1.9%
1/54 • Number of events 1
|
4.7%
3/64 • Number of events 4
|
|
Vascular disorders
Intra-abdominal haematoma
|
5.3%
3/57 • Number of events 3
|
0.00%
0/56
|
0.00%
0/54
|
0.00%
0/64
|
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