Trial Outcomes & Findings for Parathyroid Hormone (PTH) for Osteoporosis in Postmenopausal Women (NCT NCT00086619)
NCT ID: NCT00086619
Last Updated: 2013-10-30
Results Overview
Change from month 0 (pre-treatment) baseline serum aminoterminal propeptide of type I collagen (PINP), osteocalcin (OC), and C-terminal telopeptide (CTX), expressed as an area under the curve (AUC). Each marker measurement result was multiplied by the corresponding subject-specific elapsed study time interval using the trapezoidal rule, and these products were summed to generate a subject-specific AUC (months\*ng/ml) for the marker.
COMPLETED
PHASE2
80 participants
Each index of bone turnover was measured at study month 0, 1.5, 3, 6, 7.5, 9, 12, 13.5, 15, and 18.
2013-10-30
Participant Flow
Postmenopausal women with low bone density were recruited from 2004-2007 to participate in this study at a single academic medical center. Recruitment letters were sent to women in the Greater Boston area and the trial was also posted on clinicaltrials.gov.
Must satisfy inclusion and exclusion criteria.
Participant milestones
| Measure |
Constant Dose PTH
Participants received constant dose synthetic hPTH 1-34 (30 mcg/day).
|
Ascending Dose PTH
Participants received ascending dose synthetic hPTH 1-34 (20-30-40 mcg/day).
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
Completed Baseline Visit
|
34
|
36
|
|
Overall Study
Completed 12 Month Visit
|
26
|
26
|
|
Overall Study
COMPLETED
|
25
|
23
|
|
Overall Study
NOT COMPLETED
|
15
|
17
|
Reasons for withdrawal
| Measure |
Constant Dose PTH
Participants received constant dose synthetic hPTH 1-34 (30 mcg/day).
|
Ascending Dose PTH
Participants received ascending dose synthetic hPTH 1-34 (20-30-40 mcg/day).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
|
Overall Study
Adverse Event
|
8
|
10
|
|
Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
Parathyroid Hormone (PTH) for Osteoporosis in Postmenopausal Women
Baseline characteristics by cohort
| Measure |
Constant Dose PTH
n=40 Participants
Participants received constant dose synthetic hPTH 1-34 (30 mcg/day).
|
Ascending Dose PTH
n=40 Participants
Participants received ascending dose synthetic hPTH 1-34 (20-30-40 mcg/day).
|
Total
n=80 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
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age Continuous
|
63.3 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
62.1 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
62.7 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
80 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Each index of bone turnover was measured at study month 0, 1.5, 3, 6, 7.5, 9, 12, 13.5, 15, and 18.Population: Because this was a physiologic study evaluating the impact of stepwise increases in teriparatide, per protocol analysis was performed as was pre-specified in our analysis plan. Outcomes data were analyzed in women who remained on teriparatide throughout the first stepwise increase (i.e. until month 12 or later).
Change from month 0 (pre-treatment) baseline serum aminoterminal propeptide of type I collagen (PINP), osteocalcin (OC), and C-terminal telopeptide (CTX), expressed as an area under the curve (AUC). Each marker measurement result was multiplied by the corresponding subject-specific elapsed study time interval using the trapezoidal rule, and these products were summed to generate a subject-specific AUC (months\*ng/ml) for the marker.
Outcome measures
| Measure |
Constant Dose PTH
n=26 Participants
Participants received constant dose synthetic hPTH 1-34 (30 mcg/day).
|
Ascending Dose PTH
n=26 Participants
Participants received ascending dose synthetic hPTH 1-34 (20-30-40 mcg/day).
|
|---|---|---|
|
Changes in Indices of Bone Turnover
PINP
|
4418 months*(ng/ml - baseline ng/ml)
Standard Deviation 2732
|
3696 months*(ng/ml - baseline ng/ml)
Standard Deviation 1735
|
|
Changes in Indices of Bone Turnover
OC
|
956 months*(ng/ml - baseline ng/ml)
Standard Deviation 416
|
822 months*(ng/ml - baseline ng/ml)
Standard Deviation 312
|
|
Changes in Indices of Bone Turnover
CTX
|
22 months*(ng/ml - baseline ng/ml)
Standard Deviation 11
|
19 months*(ng/ml - baseline ng/ml)
Standard Deviation 9
|
SECONDARY outcome
Timeframe: baseline and 18 months (12 months in 4 subjects)Population: Final BMD was measured after 18 months of study therapy in 48 subjects and measured after 12 months of study therapy in 4 others who thereafter dropped out prematurely. Of the latter 4, 3 were in the ascending dose arm and 1 was in the constant dose arm.
Percent change in BMD of the spine, femur, radius, and ulna, and subtotal body, calculated as 100\*\[(final - month 0)/month 0\] in subjects who took study therapy for at least 12 months.
Outcome measures
| Measure |
Constant Dose PTH
n=26 Participants
Participants received constant dose synthetic hPTH 1-34 (30 mcg/day).
|
Ascending Dose PTH
n=26 Participants
Participants received ascending dose synthetic hPTH 1-34 (20-30-40 mcg/day).
|
|---|---|---|
|
Change in Bone Mineral Density (BMD)
1/3 Radius BMD
|
-4.6 percent change
Standard Deviation 2.8
|
-3.1 percent change
Standard Deviation 3.3
|
|
Change in Bone Mineral Density (BMD)
Femoral neck BMD
|
1.7 percent change
Standard Deviation 3.0
|
3.5 percent change
Standard Deviation 2.7
|
|
Change in Bone Mineral Density (BMD)
Spine BMD
|
5.9 percent change
Standard Deviation 4.6
|
7.4 percent change
Standard Deviation 3.8
|
|
Change in Bone Mineral Density (BMD)
Subtotal BMD
|
-1.6 percent change
Standard Deviation 0.8
|
-0.9 percent change
Standard Deviation 0.5
|
|
Change in Bone Mineral Density (BMD)
Total hip BMD
|
1.4 percent change
Standard Deviation 3.1
|
1.3 percent change
Standard Deviation 2.5
|
Adverse Events
Constant Dose PTH
Ascending Dose PTH
Serious adverse events
| Measure |
Constant Dose PTH
n=40 participants at risk
Participants received constant dose synthetic hPTH 1-34 (30 mcg/day).
|
Ascending Dose PTH
n=40 participants at risk
Participants received ascending dose synthetic hPTH 1-34 (20-30-40 mcg/day).
|
|---|---|---|
|
Endocrine disorders
Hypercalcemia requiring emergency room visit
|
0.00%
0/40
|
2.5%
1/40 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diagnosed with lung cancer
|
0.00%
0/40
|
2.5%
1/40 • Number of events 1
|
Other adverse events
| Measure |
Constant Dose PTH
n=40 participants at risk
Participants received constant dose synthetic hPTH 1-34 (30 mcg/day).
|
Ascending Dose PTH
n=40 participants at risk
Participants received ascending dose synthetic hPTH 1-34 (20-30-40 mcg/day).
|
|---|---|---|
|
Endocrine disorders
Mild hypercalcemia or hypercalciuria
|
7.5%
3/40 • Number of events 3
|
12.5%
5/40 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
0.00%
0/40
|
2.5%
1/40 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/40
|
2.5%
1/40 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40 • Number of events 1
|
2.5%
1/40 • Number of events 1
|
|
Blood and lymphatic system disorders
Lower extremity edema
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place