Trial Outcomes & Findings for Comparison Study of PTHrP and PTH to Treat Osteoporosis (NCT NCT00853723)
NCT ID: NCT00853723
Last Updated: 2016-03-24
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
105 participants
Primary outcome timeframe
Baseline, Day 15, Day 30, Day 60, Day 90
Results posted on
2016-03-24
Participant Flow
Participant milestones
| Measure |
PTHrP 400 mcg/Day
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
|
PTHrP 600 mcg/Day
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
|
PTH 20 mcg/Day
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
|
|---|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
35
|
|
Overall Study
COMPLETED
|
29
|
28
|
33
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
2
|
Reasons for withdrawal
| Measure |
PTHrP 400 mcg/Day
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
|
PTHrP 600 mcg/Day
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
|
PTH 20 mcg/Day
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
2
|
1
|
Baseline Characteristics
Comparison Study of PTHrP and PTH to Treat Osteoporosis
Baseline characteristics by cohort
| Measure |
PTHrP 400 mcg/Day
n=35 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
|
PTHrP 600 mcg/Day
n=35 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
|
PTH 20 mcg/Day
n=35 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Age, Continuous
|
60.6 years
STANDARD_DEVIATION 5.22 • n=5 Participants
|
61.2 years
STANDARD_DEVIATION 5.10 • n=7 Participants
|
62.4 years
STANDARD_DEVIATION 5.26 • n=5 Participants
|
61.4 years
STANDARD_DEVIATION 5.20 • n=4 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
105 Participants
n=4 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
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
35 participants
n=7 Participants
|
35 participants
n=5 Participants
|
105 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 15, Day 30, Day 60, Day 90Outcome measures
| Measure |
PTHrP 400 mcg/Day
n=29 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
|
PTHrP 600 mcg/Day
n=28 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
|
PTH 20 mcg/Day
n=33 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
|
|---|---|---|---|
|
Procallagen-1 Amino-terminal Peptide (P1NP)
Day 15
|
32.54 percentage change from baseline
Standard Error 5.09
|
23.51 percentage change from baseline
Standard Error 7.04
|
60.67 percentage change from baseline
Standard Error 7.35
|
|
Procallagen-1 Amino-terminal Peptide (P1NP)
Day 30
|
48.89 percentage change from baseline
Standard Error 5.7
|
83.14 percentage change from baseline
Standard Error 12.48
|
97.27 percentage change from baseline
Standard Error 10.79
|
|
Procallagen-1 Amino-terminal Peptide (P1NP)
Day 60
|
34.71 percentage change from baseline
Standard Error 5.78
|
87.39 percentage change from baseline
Standard Error 22.24
|
125.46 percentage change from baseline
Standard Error 17.46
|
|
Procallagen-1 Amino-terminal Peptide (P1NP)
Day 90
|
46.07 percentage change from baseline
Standard Error 12.12
|
84.09 percentage change from baseline
Standard Error 20.57
|
171.49 percentage change from baseline
Standard Error 26.67
|
PRIMARY outcome
Timeframe: Baseline, Day 15, Day 30, Day 60, Day 90Outcome measures
| Measure |
PTHrP 400 mcg/Day
n=29 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
|
PTHrP 600 mcg/Day
n=28 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
|
PTH 20 mcg/Day
n=33 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
|
|---|---|---|---|
|
Carboxy-terminal Telopeptides of Collagen-1 (CTX)
Day 60
|
4.13 percentage change from baseline
Standard Error 7.93
|
14.38 percentage change from baseline
Standard Error 15.89
|
52.98 percentage change from baseline
Standard Error 22.23
|
|
Carboxy-terminal Telopeptides of Collagen-1 (CTX)
Day 90
|
32.65 percentage change from baseline
Standard Error 14.86
|
25.65 percentage change from baseline
Standard Error 11.75
|
92.46 percentage change from baseline
Standard Error 18.68
|
|
Carboxy-terminal Telopeptides of Collagen-1 (CTX)
Day 15
|
-12.40 percentage change from baseline
Standard Error 7.19
|
10.25 percentage change from baseline
Standard Error 10.66
|
4.87 percentage change from baseline
Standard Error 8.09
|
|
Carboxy-terminal Telopeptides of Collagen-1 (CTX)
Day 30
|
1.60 percentage change from baseline
Standard Error 10.65
|
9.59 percentage change from baseline
Standard Error 16.49
|
13.89 percentage change from baseline
Standard Error 12.43
|
SECONDARY outcome
Timeframe: 90 daysOutcome measures
| Measure |
PTHrP 400 mcg/Day
n=29 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
|
PTHrP 600 mcg/Day
n=28 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
|
PTH 20 mcg/Day
n=33 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
|
|---|---|---|---|
|
Changes in Bone Mineral Density of the Lumbar Spine.
|
1.89 Percent change from baseline
Standard Error 0.49
|
1.52 Percent change from baseline
Standard Error 0.61
|
2.17 Percent change from baseline
Standard Error 0.60
|
SECONDARY outcome
Timeframe: 90 daysOutcome measures
| Measure |
PTHrP 400 mcg/Day
n=29 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
|
PTHrP 600 mcg/Day
n=28 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
|
PTH 20 mcg/Day
n=33 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
|
|---|---|---|---|
|
Changes in Bone Mineral Density of the Total Hip.
|
0.68 Percent change from baseline
Standard Error 0.29
|
0.72 Percent change from baseline
Standard Error 0.30
|
0.54 Percent change from baseline
Standard Error 0.45
|
SECONDARY outcome
Timeframe: 90 daysOutcome measures
| Measure |
PTHrP 400 mcg/Day
n=29 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
|
PTHrP 600 mcg/Day
n=28 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
|
PTH 20 mcg/Day
n=33 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
|
|---|---|---|---|
|
Changes in Bone Mineral Density of the Femoral Neck.
|
0.91 Percent change from baseline
Standard Error 0.41
|
0.54 Percent change from baseline
Standard Error 0.48
|
0.61 Percent change from baseline
Standard Error 0.49
|
SECONDARY outcome
Timeframe: 90 daysOutcome measures
| Measure |
PTHrP 400 mcg/Day
n=29 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
|
PTHrP 600 mcg/Day
n=28 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
|
PTH 20 mcg/Day
n=33 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
|
|---|---|---|---|
|
Changes in Bone Mineral Density of the Forearm.
|
-0.48 Percent change from baseline
Standard Error 0.61
|
-0.99 Percent change from baseline
Standard Error 0.78
|
-0.97 Percent change from baseline
Standard Error 0.49
|
SECONDARY outcome
Timeframe: 90 daysOutcome measures
| Measure |
PTHrP 400 mcg/Day
n=29 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
|
PTHrP 600 mcg/Day
n=28 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
|
PTH 20 mcg/Day
n=33 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
|
|---|---|---|---|
|
Changes in Bone Mineral Density of the Distal 1/3 Radius.
|
-0.35 Percent change from baseline
Standard Error 0.54
|
-0.34 Percent change from baseline
Standard Error 0.96
|
-0.82 Percent change from baseline
Standard Error 0.64
|
SECONDARY outcome
Timeframe: Baseline, Day 15, Day 30, Day 60, Day 90Outcome measures
| Measure |
PTHrP 400 mcg/Day
n=29 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
|
PTHrP 600 mcg/Day
n=28 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
|
PTH 20 mcg/Day
n=33 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
|
|---|---|---|---|
|
Total Serum Calcium (mg/dl)
Baseline
|
9.48 mg/dl
Standard Error 0.06
|
9.51 mg/dl
Standard Error 0.06
|
9.49 mg/dl
Standard Error 0.06
|
|
Total Serum Calcium (mg/dl)
Day 15
|
9.95 mg/dl
Standard Error 0.09
|
9.87 mg/dl
Standard Error 0.09
|
9.57 mg/dl
Standard Error 0.02
|
|
Total Serum Calcium (mg/dl)
Day 30
|
9.73 mg/dl
Standard Error 0.09
|
9.67 mg/dl
Standard Error 0.06
|
9.55 mg/dl
Standard Error 0.06
|
|
Total Serum Calcium (mg/dl)
Day 60
|
9.71 mg/dl
Standard Error 0.07
|
9.61 mg/dl
Standard Error 0.06
|
9.58 mg/dl
Standard Error 0.06
|
|
Total Serum Calcium (mg/dl)
Day 90, time 0
|
9.56 mg/dl
Standard Error .07
|
9.45 mg/dl
Standard Error 0.07
|
9.44 mg/dl
Standard Error 0.06
|
|
Total Serum Calcium (mg/dl)
Day 90, time 3 hours
|
9.90 mg/dl
Standard Error 0.08
|
9.76 mg/dl
Standard Error 0.07
|
9.75 mg/dl
Standard Error 0.06
|
|
Total Serum Calcium (mg/dl)
day 90, time 6 hours
|
9.90 mg/dl
Standard Error 0.07
|
9.81 mg/dl
Standard Error 0.10
|
9.78 mg/dl
Standard Error 0.07
|
SECONDARY outcome
Timeframe: Baseline, Day 15, Day 30, Day 60, Day 90Outcome measures
| Measure |
PTHrP 400 mcg/Day
n=29 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
|
PTHrP 600 mcg/Day
n=28 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
|
PTH 20 mcg/Day
n=33 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
|
|---|---|---|---|
|
Serum Phosphorous
Baseline
|
4.0 mg/dl
Standard Error 0.07
|
3.93 mg/dl
Standard Error 0.08
|
4.09 mg/dl
Standard Error 0.08
|
|
Serum Phosphorous
Day 15
|
3.78 mg/dl
Standard Error 0.07
|
3.68 mg/dl
Standard Error 0.08
|
4.13 mg/dl
Standard Error 0.08
|
|
Serum Phosphorous
Day 30
|
3.87 mg/dl
Standard Error 0.09
|
3.71 mg/dl
Standard Error 0.09
|
4.19 mg/dl
Standard Error 0.11
|
|
Serum Phosphorous
Day 60
|
4.02 mg/dl
Standard Error 0.07
|
3.97 mg/dl
Standard Error 0.08
|
4.28 mg/dl
Standard Error 0.08
|
|
Serum Phosphorous
Day 90
|
4.05 mg/dl
Standard Error 0.09
|
3.98 mg/dl
Standard Error 0.07
|
4.10 mg/dl
Standard Error 0.07
|
SECONDARY outcome
Timeframe: 90 daysOutcome measures
| Measure |
PTHrP 400 mcg/Day
n=29 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
|
PTHrP 600 mcg/Day
n=28 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
|
PTH 20 mcg/Day
n=33 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
|
|---|---|---|---|
|
24 Hour Urine Calcium
Baseline
|
206.37 mg/gm creatinine
Standard Error 14.08
|
213.07 mg/gm creatinine
Standard Error 16.22
|
209.99 mg/gm creatinine
Standard Error 14.47
|
|
24 Hour Urine Calcium
Day 90
|
260.46 mg/gm creatinine
Standard Error 22.72
|
235.25 mg/gm creatinine
Standard Error 20.34
|
232.48 mg/gm creatinine
Standard Error 17.47
|
SECONDARY outcome
Timeframe: Baseline, Day 15, Day 30, Day 60, Day 90Outcome measures
| Measure |
PTHrP 400 mcg/Day
n=29 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
|
PTHrP 600 mcg/Day
n=28 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
|
PTH 20 mcg/Day
n=33 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
|
|---|---|---|---|
|
1,25 Vitamin D
Baseline
|
49.06 pg/ml
Standard Error 3.24
|
42.49 pg/ml
Standard Error 2.20
|
42.51 pg/ml
Standard Error 1.75
|
|
1,25 Vitamin D
Day 15
|
84.92 pg/ml
Standard Error 5.65
|
63.07 pg/ml
Standard Error 4.71
|
65.25 pg/ml
Standard Error 3.68
|
|
1,25 Vitamin D
Day 30
|
76.04 pg/ml
Standard Error 4.65
|
65.15 pg/ml
Standard Error 3.71
|
67.29 pg/ml
Standard Error 3.79
|
|
1,25 Vitamin D
Day 60
|
67.85 pg/ml
Standard Error 4.40
|
57.02 pg/ml
Standard Error 4.07
|
58.15 pg/ml
Standard Error 2.98
|
|
1,25 Vitamin D
Day 90
|
64.36 pg/ml
Standard Error 4.34
|
55.08 pg/ml
Standard Error 4.20
|
53.73 pg/ml
Standard Error 2.30
|
SECONDARY outcome
Timeframe: Baseline, Day 15, Day 30, Day 60, Day 90(Serum Creatinine X Urine Calcium)/(Serum Calcium X Urine Creatinine)
Outcome measures
| Measure |
PTHrP 400 mcg/Day
n=29 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
|
PTHrP 600 mcg/Day
n=28 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
|
PTH 20 mcg/Day
n=33 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
|
|---|---|---|---|
|
Fractional Excretion of Calcium
Day 90
|
3.10 % excreted
Standard Error 0.25
|
2.89 % excreted
Standard Error 0.27
|
3.37 % excreted
Standard Error 0.37
|
|
Fractional Excretion of Calcium
Baseline
|
2.38 % excreted
Standard Error 0.21
|
2.71 % excreted
Standard Error 0.24
|
2.30 % excreted
Standard Error 0.23
|
|
Fractional Excretion of Calcium
Day 15
|
3.42 % excreted
Standard Error 033
|
4.18 % excreted
Standard Error 0.39
|
2.55 % excreted
Standard Error 0.27
|
|
Fractional Excretion of Calcium
Day 30
|
3.27 % excreted
Standard Error 0.34
|
3.74 % excreted
Standard Error 0.27
|
2.92 % excreted
Standard Error 0.34
|
|
Fractional Excretion of Calcium
Day 60
|
3.38 % excreted
Standard Error 0.34
|
2.89 % excreted
Standard Error 0.28
|
2.95 % excreted
Standard Error 0.29
|
SECONDARY outcome
Timeframe: Baseline, Day 15, Day 30, Day 60, Day 90Fractional tubular reabsorption of phosphate (TRP) = 1-{(U phos/P phos) x ( P creat/U creat)} if TRP \< or = 0.86 then TMP/GFR = TRP x P phos if TRP \> 0.86 then TMP/GFR = 0.3 x TRP/{1-(0.8 x TRP)} x P phos U= urine, P = plasma
Outcome measures
| Measure |
PTHrP 400 mcg/Day
n=29 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
|
PTHrP 600 mcg/Day
n=28 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
|
PTH 20 mcg/Day
n=33 Participants
Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
|
|---|---|---|---|
|
Tubular Maximum for Phosphorous/Glomerular Filtration Rate (TMP/GFR)
Baseline
|
3.80 mg/dl
Standard Error 0.11
|
3.71 mg/dl
Standard Error 0.11
|
3.96 mg/dl
Standard Error 0.12
|
|
Tubular Maximum for Phosphorous/Glomerular Filtration Rate (TMP/GFR)
Day 15
|
3.78 mg/dl
Standard Error 0.14
|
3.47 mg/dl
Standard Error 0.15
|
4.18 mg/dl
Standard Error 0.12
|
|
Tubular Maximum for Phosphorous/Glomerular Filtration Rate (TMP/GFR)
Day 30
|
3.88 mg/dl
Standard Error 0.14
|
3.61 mg/dl
Standard Error 0.14
|
4.03 mg/dl
Standard Error 0.12
|
|
Tubular Maximum for Phosphorous/Glomerular Filtration Rate (TMP/GFR)
Day 60
|
4.02 mg/dl
Standard Error 0.14
|
3.84 mg/dl
Standard Error 0.13
|
4.28 mg/dl
Standard Error 0.13
|
|
Tubular Maximum for Phosphorous/Glomerular Filtration Rate (TMP/GFR)
Day 90
|
4.11 mg/dl
Standard Error 0.11
|
3.90 mg/dl
Standard Error 0.12
|
4.00 mg/dl
Standard Error 0.13
|
Adverse Events
PTHrP 400 mcg/Day
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
PTHrP 600 mcg/Day
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
PTH 20 mcg/Day
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PTHrP 400 mcg/Day
n=35 participants at risk
Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.
|
PTHrP 600 mcg/Day
n=35 participants at risk
Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 600 micrograms daily for three months.
|
PTH 20 mcg/Day
n=35 participants at risk
Post-menopausal women with osteoporosis will subcutaneously administer the FDA approved dose of PTH 20 micrograms daily for three months.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Dermatologic
|
54.3%
19/35
Adverse event data was collected at each study visit.
|
65.7%
23/35
Adverse event data was collected at each study visit.
|
40.0%
14/35
Adverse event data was collected at each study visit.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
20.0%
7/35
Adverse event data was collected at each study visit.
|
22.9%
8/35
Adverse event data was collected at each study visit.
|
28.6%
10/35
Adverse event data was collected at each study visit.
|
|
Nervous system disorders
Neurologic
|
31.4%
11/35
Adverse event data was collected at each study visit.
|
31.4%
11/35
Adverse event data was collected at each study visit.
|
34.3%
12/35
Adverse event data was collected at each study visit.
|
|
Psychiatric disorders
Psychological
|
14.3%
5/35
Adverse event data was collected at each study visit.
|
31.4%
11/35
Adverse event data was collected at each study visit.
|
34.3%
12/35
Adverse event data was collected at each study visit.
|
|
Gastrointestinal disorders
Gastrointestinal
|
37.1%
13/35
Adverse event data was collected at each study visit.
|
34.3%
12/35
Adverse event data was collected at each study visit.
|
31.4%
11/35
Adverse event data was collected at each study visit.
|
|
Infections and infestations
Infection
|
11.4%
4/35
Adverse event data was collected at each study visit.
|
11.4%
4/35
Adverse event data was collected at each study visit.
|
8.6%
3/35
Adverse event data was collected at each study visit.
|
|
Cardiac disorders
Cardiovascular
|
0.00%
0/35
Adverse event data was collected at each study visit.
|
11.4%
4/35
Adverse event data was collected at each study visit.
|
5.7%
2/35
Adverse event data was collected at each study visit.
|
|
Renal and urinary disorders
Genitourinary
|
8.6%
3/35
Adverse event data was collected at each study visit.
|
0.00%
0/35
Adverse event data was collected at each study visit.
|
5.7%
2/35
Adverse event data was collected at each study visit.
|
|
General disorders
Other
|
48.6%
17/35
Adverse event data was collected at each study visit.
|
42.9%
15/35
Adverse event data was collected at each study visit.
|
57.1%
20/35
Adverse event data was collected at each study visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place