Trial Outcomes & Findings for Dose Ranging Study - Macroflux Parathyroid Hormone (PTH) in Postmenopausal Women With Osteoporosis (NCT NCT00489918)
NCT ID: NCT00489918
Last Updated: 2018-07-31
Results Overview
Percent Change in Lumbar Spine Bone Mineral Density (BMD) from Baseline to Week 24
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
165 participants
Primary outcome timeframe
24 weeks
Results posted on
2018-07-31
Participant Flow
Participant milestones
| Measure |
Macroflux® Placebo
Macroflux® placebo patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
Macroflux® 20 mcg
Macroflux® 20 mcg patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
Macroflux® 30 mcg
Macroflux® 30 mcg patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
Macroflux® 40 mcg
Macroflux® 40 mcg patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
FORTEO®
FORTEO® 20 mcg injection
teriparatide: FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
33
|
34
|
32
|
33
|
33
|
|
Overall Study
COMPLETED
|
31
|
32
|
28
|
32
|
32
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
4
|
1
|
1
|
Reasons for withdrawal
| Measure |
Macroflux® Placebo
Macroflux® placebo patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
Macroflux® 20 mcg
Macroflux® 20 mcg patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
Macroflux® 30 mcg
Macroflux® 30 mcg patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
Macroflux® 40 mcg
Macroflux® 40 mcg patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
FORTEO®
FORTEO® 20 mcg injection
teriparatide: FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
1
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Dose Ranging Study - Macroflux Parathyroid Hormone (PTH) in Postmenopausal Women With Osteoporosis
Baseline characteristics by cohort
| Measure |
Macroflux® Placebo
n=33 Participants
Macroflux® placebo patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
Macroflux® 20 mcg
n=34 Participants
Macroflux® 20 mcg patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
Macroflux® 30 mcg
n=32 Participants
Macroflux® 30 mcg patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
Macroflux® 40 mcg
n=33 Participants
Macroflux® 40 mcg patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
FORTEO®
n=33 Participants
FORTEO® 20 mcg injection
teriparatide: FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh
|
Total
n=165 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
64.8 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
64.1 years
STANDARD_DEVIATION 7.5 • n=7 Participants
|
63.6 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
64.6 years
STANDARD_DEVIATION 7.3 • n=4 Participants
|
63.2 years
STANDARD_DEVIATION 6.8 • n=21 Participants
|
64.06 years
STANDARD_DEVIATION 6.9 • n=10 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
165 Participants
n=10 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
|
0 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
4 participants
n=5 Participants
|
9 participants
n=7 Participants
|
10 participants
n=5 Participants
|
14 participants
n=4 Participants
|
8 participants
n=21 Participants
|
45 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
29 participants
n=5 Participants
|
25 participants
n=7 Participants
|
22 participants
n=5 Participants
|
19 participants
n=4 Participants
|
24 participants
n=21 Participants
|
119 participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
1 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Intent to treat (ITT)/Safety Population
Percent Change in Lumbar Spine Bone Mineral Density (BMD) from Baseline to Week 24
Outcome measures
| Measure |
Macroflux® Placebo
n=33 Participants
Macroflux® placebo patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
Macroflux® 20 mcg
n=34 Participants
Macroflux® 20 mcg patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
Macroflux® 30 mcg
n=32 Participants
Macroflux® 30 mcg patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
Macroflux® 40 mcg
n=33 Participants
Macroflux® 40 mcg patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
FORTEO®
n=33 Participants
FORTEO® 20 mcg injection
teriparatide: FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh
|
|---|---|---|---|---|---|
|
Percent Change in Lumbar Spine Bone Mineral Density (BMD): Baseline to Week 24
|
-0.33 percent change
Standard Deviation 3.467
|
2.96 percent change
Standard Deviation 3.524
|
3.47 percent change
Standard Deviation 3.575
|
4.97 percent change
Standard Deviation 4.114
|
3.55 percent change
Standard Deviation 3.730
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT/Safety Population
Percent Change in Lumbar Spine Bone Mineral Density from Baseline to Week 12
Outcome measures
| Measure |
Macroflux® Placebo
n=33 Participants
Macroflux® placebo patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
Macroflux® 20 mcg
n=34 Participants
Macroflux® 20 mcg patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
Macroflux® 30 mcg
n=32 Participants
Macroflux® 30 mcg patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
Macroflux® 40 mcg
n=33 Participants
Macroflux® 40 mcg patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
FORTEO®
n=33 Participants
FORTEO® 20 mcg injection
teriparatide: FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh
|
|---|---|---|---|---|---|
|
Percent Change in Lumbar Spine Bone Mineral Density: Baseline to Week 12
|
0.97 Percent change
Standard Deviation 3.312
|
1.55 Percent change
Standard Deviation 2.606
|
2.04 Percent change
Standard Deviation 3.277
|
2.5 Percent change
Standard Deviation 2.86
|
2.81 Percent change
Standard Deviation 2.771
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT/Safety Population
Absolute Change in Lumbar Spine BMD from Baseline to Week 12
Outcome measures
| Measure |
Macroflux® Placebo
n=33 Participants
Macroflux® placebo patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
Macroflux® 20 mcg
n=34 Participants
Macroflux® 20 mcg patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
Macroflux® 30 mcg
n=32 Participants
Macroflux® 30 mcg patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
Macroflux® 40 mcg
n=33 Participants
Macroflux® 40 mcg patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
FORTEO®
n=33 Participants
FORTEO® 20 mcg injection
teriparatide: FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh
|
|---|---|---|---|---|---|
|
Absolute Change in Lumbar Spine BMD: Baseline to Week 12
|
0.007 g/cm^2
Standard Deviation 0.0234
|
0.011 g/cm^2
Standard Deviation 0.0191
|
0.014 g/cm^2
Standard Deviation 0.0238
|
0.017 g/cm^2
Standard Deviation 0.0285
|
0.021 g/cm^2
Standard Deviation 0.0201
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: ITT/Safety Population
Percent Change in Total Hip Bone Mineral Density from Baseline to Week 24
Outcome measures
| Measure |
Macroflux® Placebo
n=33 Participants
Macroflux® placebo patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
Macroflux® 20 mcg
n=34 Participants
Macroflux® 20 mcg patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
Macroflux® 30 mcg
n=32 Participants
Macroflux® 30 mcg patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
Macroflux® 40 mcg
n=33 Participants
Macroflux® 40 mcg patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
FORTEO®
n=33 Participants
FORTEO® 20 mcg injection
teriparatide: FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh
|
|---|---|---|---|---|---|
|
Percent Change in Total Hip Bone Mineral Density: Baseline to Week 24
|
-0.634 Percent change
Standard Deviation 1.9719
|
0.138 Percent change
Standard Deviation 2.0386
|
0.553 Percent change
Standard Deviation 2.3694
|
1.331 Percent change
Standard Deviation 2.1111
|
0.094 Percent change
Standard Deviation 2.6194
|
SECONDARY outcome
Timeframe: 24 WeeksPopulation: ITT/Safety Population
Percent Change in Femoral Neck BMD from Baseline to Week 24
Outcome measures
| Measure |
Macroflux® Placebo
n=33 Participants
Macroflux® placebo patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
Macroflux® 20 mcg
n=34 Participants
Macroflux® 20 mcg patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
Macroflux® 30 mcg
n=32 Participants
Macroflux® 30 mcg patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
Macroflux® 40 mcg
n=33 Participants
Macroflux® 40 mcg patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
FORTEO®
n=33 Participants
FORTEO® 20 mcg injection
teriparatide: FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh
|
|---|---|---|---|---|---|
|
Percent Change in Femoral Neck BMD: Baseline to Week 24
|
0.172 Percent change
Standard Deviation 3.3432
|
0.949 Percent change
Standard Deviation 3.2975
|
0.599 Percent change
Standard Deviation 2.6127
|
0.750 Percent change
Standard Deviation 2.6132
|
-0.012 Percent change
Standard Deviation 3.6600
|
Adverse Events
Macroflux® Placebo
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Macroflux® 20 mcg
Serious events: 1 serious events
Other events: 32 other events
Deaths: 0 deaths
Macroflux® 30 mcg
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
Macroflux® 40 mcg
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
FORTEO®
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Macroflux® Placebo
n=33 participants at risk
Macroflux® placebo patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
Macroflux® 20 mcg
n=34 participants at risk
Macroflux® 20 mcg patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
Macroflux® 30 mcg
n=32 participants at risk
Macroflux® 30 mcg patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
Macroflux® 40 mcg
n=33 participants at risk
Macroflux® 40 mcg patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
FORTEO®
n=33 participants at risk
FORTEO® 20 mcg injection
teriparatide: FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Subdural hematoma
|
3.0%
1/33 • Number of events 1 • 24 weeks
|
0.00%
0/34 • 24 weeks
|
0.00%
0/32 • 24 weeks
|
0.00%
0/33 • 24 weeks
|
0.00%
0/33 • 24 weeks
|
|
Metabolism and nutrition disorders
dehydration
|
0.00%
0/33 • 24 weeks
|
2.9%
1/34 • Number of events 1 • 24 weeks
|
0.00%
0/32 • 24 weeks
|
0.00%
0/33 • 24 weeks
|
0.00%
0/33 • 24 weeks
|
Other adverse events
| Measure |
Macroflux® Placebo
n=33 participants at risk
Macroflux® placebo patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
Macroflux® 20 mcg
n=34 participants at risk
Macroflux® 20 mcg patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
Macroflux® 30 mcg
n=32 participants at risk
Macroflux® 30 mcg patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
Macroflux® 40 mcg
n=33 participants at risk
Macroflux® 40 mcg patch
teriparatide: Macroflux® patch applied to the abdomen for 30 minutes daily
|
FORTEO®
n=33 participants at risk
FORTEO® 20 mcg injection
teriparatide: FORTEO® injection administered subcutaneously (SC) either to the abdomen or thigh
|
|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Application site erythema
|
39.4%
13/33 • 24 weeks
|
38.2%
13/34 • 24 weeks
|
46.9%
15/32 • 24 weeks
|
39.4%
13/33 • 24 weeks
|
3.0%
1/33 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Application site discolorations
|
9.1%
3/33 • 24 weeks
|
32.4%
11/34 • 24 weeks
|
34.4%
11/32 • 24 weeks
|
21.2%
7/33 • 24 weeks
|
0.00%
0/33 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Application site bruising
|
0.00%
0/33 • 24 weeks
|
5.9%
2/34 • 24 weeks
|
9.4%
3/32 • 24 weeks
|
6.1%
2/33 • 24 weeks
|
0.00%
0/33 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Application site bleeding
|
0.00%
0/33 • 24 weeks
|
23.5%
8/34 • 24 weeks
|
43.8%
14/32 • 24 weeks
|
3.0%
1/33 • 24 weeks
|
0.00%
0/33 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Application site edema
|
3.0%
1/33 • 24 weeks
|
5.9%
2/34 • 24 weeks
|
9.4%
3/32 • 24 weeks
|
3.0%
1/33 • 24 weeks
|
0.00%
0/33 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Edema peripheral
|
0.00%
0/33 • 24 weeks
|
5.9%
2/34 • 24 weeks
|
0.00%
0/32 • 24 weeks
|
3.0%
1/33 • 24 weeks
|
0.00%
0/33 • 24 weeks
|
|
Infections and infestations
Nasopharyngitis
|
6.1%
2/33 • 24 weeks
|
0.00%
0/34 • 24 weeks
|
3.1%
1/32 • 24 weeks
|
12.1%
4/33 • 24 weeks
|
0.00%
0/33 • 24 weeks
|
|
Infections and infestations
Urinary tract infection
|
3.0%
1/33 • 24 weeks
|
5.9%
2/34 • 24 weeks
|
3.1%
1/32 • 24 weeks
|
6.1%
2/33 • 24 weeks
|
3.0%
1/33 • 24 weeks
|
|
Infections and infestations
Influenza
|
6.1%
2/33 • 24 weeks
|
5.9%
2/34 • 24 weeks
|
6.2%
2/32 • 24 weeks
|
3.0%
1/33 • 24 weeks
|
3.0%
1/33 • 24 weeks
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/33 • 24 weeks
|
0.00%
0/34 • 24 weeks
|
0.00%
0/32 • 24 weeks
|
3.0%
1/33 • 24 weeks
|
6.1%
2/33 • 24 weeks
|
|
Infections and infestations
Bronchitis
|
6.1%
2/33 • 24 weeks
|
0.00%
0/34 • 24 weeks
|
3.1%
1/32 • 24 weeks
|
0.00%
0/33 • 24 weeks
|
0.00%
0/33 • 24 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
6.1%
2/33 • 24 weeks
|
0.00%
0/34 • 24 weeks
|
0.00%
0/32 • 24 weeks
|
6.1%
2/33 • 24 weeks
|
0.00%
0/33 • 24 weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/33 • 24 weeks
|
5.9%
2/34 • 24 weeks
|
3.1%
1/32 • 24 weeks
|
3.0%
1/33 • 24 weeks
|
0.00%
0/33 • 24 weeks
|
|
Gastrointestinal disorders
Colitis
|
6.1%
2/33 • 24 weeks
|
0.00%
0/34 • 24 weeks
|
0.00%
0/32 • 24 weeks
|
0.00%
0/33 • 24 weeks
|
3.0%
1/33 • 24 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
3.0%
1/33 • 24 weeks
|
11.8%
4/34 • 24 weeks
|
6.2%
2/32 • 24 weeks
|
0.00%
0/33 • 24 weeks
|
0.00%
0/33 • 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/33 • 24 weeks
|
8.8%
3/34 • 24 weeks
|
6.2%
2/32 • 24 weeks
|
0.00%
0/33 • 24 weeks
|
6.1%
2/33 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
6.1%
2/33 • 24 weeks
|
11.8%
4/34 • 24 weeks
|
0.00%
0/32 • 24 weeks
|
12.1%
4/33 • 24 weeks
|
18.2%
6/33 • 24 weeks
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/33 • 24 weeks
|
0.00%
0/34 • 24 weeks
|
0.00%
0/32 • 24 weeks
|
0.00%
0/33 • 24 weeks
|
6.1%
2/33 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.1%
2/33 • 24 weeks
|
14.7%
5/34 • 24 weeks
|
9.4%
3/32 • 24 weeks
|
6.1%
2/33 • 24 weeks
|
15.2%
5/33 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/33 • 24 weeks
|
2.9%
1/34 • 24 weeks
|
0.00%
0/32 • 24 weeks
|
3.0%
1/33 • 24 weeks
|
6.1%
2/33 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.0%
1/33 • 24 weeks
|
0.00%
0/34 • 24 weeks
|
6.2%
2/32 • 24 weeks
|
3.0%
1/33 • 24 weeks
|
3.0%
1/33 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.0%
1/33 • 24 weeks
|
8.8%
3/34 • 24 weeks
|
0.00%
0/32 • 24 weeks
|
0.00%
0/33 • 24 weeks
|
3.0%
1/33 • 24 weeks
|
|
Nervous system disorders
Headache
|
6.1%
2/33 • 24 weeks
|
14.7%
5/34 • 24 weeks
|
12.5%
4/32 • 24 weeks
|
9.1%
3/33 • 24 weeks
|
12.1%
4/33 • 24 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/33 • 24 weeks
|
8.8%
3/34 • 24 weeks
|
3.1%
1/32 • 24 weeks
|
3.0%
1/33 • 24 weeks
|
0.00%
0/33 • 24 weeks
|
|
Vascular disorders
Hypertension
|
6.1%
2/33 • 24 weeks
|
2.9%
1/34 • 24 weeks
|
0.00%
0/32 • 24 weeks
|
6.1%
2/33 • 24 weeks
|
0.00%
0/33 • 24 weeks
|
|
Renal and urinary disorders
Hypercalciuria
|
6.1%
2/33 • 24 weeks
|
11.8%
4/34 • 24 weeks
|
6.2%
2/32 • 24 weeks
|
3.0%
1/33 • 24 weeks
|
3.0%
1/33 • 24 weeks
|
Additional Information
Don Kellerman, VP of Clinical Development and Medical Affairs
Zosano Pharma Inc.
Phone: (510) 745-4004
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place