Trial Outcomes & Findings for Forteo Trial on Idiopathic Osteoporosis in Premenopausal Women (NCT NCT01440803)
NCT ID: NCT01440803
Last Updated: 2019-12-11
Results Overview
Dual Energy X-ray Absorptiometry (DXA) will be used to measuring bone mineral density (BMD).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
Baseline and 12 months
Results posted on
2019-12-11
Participant Flow
Periods have been added to represent the sequential nature of the study (e.g., "Period 1: Double blind Forteo/Placebo", "Period 2: Double Blind Forteo/Forteo", "Period 3: Open Label Forteo", etc.) per PRS.
Participant milestones
| Measure |
Placebo Saline Injection
First 6 months:
Placebo Saline Injection Group receiving daily injection of saline placebo
6-12 months: Placebo Saline Injection Group receiving daily injection of Teriparatide for treatment of idiopathic osteoporosis (20 mcg)
12-24 months: Forteo open label
|
Teriparatide (Forteo)
First 6 months:
Teriparatide (Forteo) Group receiving daily injection of Teriparatide for treatment of idiopathic osteoporosis (20 mcg)
6-12 months: Teriparatide (Forteo) Group receiving daily injection of Teriparatide for treatment of idiopathic osteoporosis (20 mcg)
12-24 months: Forteo open label
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
28
|
|
Overall Study
Period 1 - Forteo/Placebo
|
13
|
28
|
|
Overall Study
Period 2 - Forteo/Forteo
|
13
|
28
|
|
Overall Study
Period 3 - Forteo Open Label
|
13
|
27
|
|
Overall Study
COMPLETED
|
11
|
24
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
Placebo Saline Injection
First 6 months:
Placebo Saline Injection Group receiving daily injection of saline placebo
6-12 months: Placebo Saline Injection Group receiving daily injection of Teriparatide for treatment of idiopathic osteoporosis (20 mcg)
12-24 months: Forteo open label
|
Teriparatide (Forteo)
First 6 months:
Teriparatide (Forteo) Group receiving daily injection of Teriparatide for treatment of idiopathic osteoporosis (20 mcg)
6-12 months: Teriparatide (Forteo) Group receiving daily injection of Teriparatide for treatment of idiopathic osteoporosis (20 mcg)
12-24 months: Forteo open label
|
|---|---|---|
|
Overall Study
Met study stopping rule
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Forteo Trial on Idiopathic Osteoporosis in Premenopausal Women
Baseline characteristics by cohort
| Measure |
Teriparatide (Forteo)
n=28 Participants
Daily injection of Teriparatide for treatment of idiopathic osteoporosis
Teriparatide: Daily injection of 20 mcg teriparatide for the treatment of idiopathic osteoporosis for 24 months.
|
Placebo Saline Injection
n=13 Participants
Daily injection of saline placebo for 6 months, followed by 24 months of teriparatide treatment for idiopathic osteoporosis.
Saline Placebo: Daily injection of saline placebo for 6 months, followed by teriparatide treatment for 24 months.
|
Total
n=41 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
|
28 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States · Columbia University
|
23 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
United States · Creighton University
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsPopulation: One patient in the Teriparatide (Forteo) arm was lost to follow up before the completion of the 12 month visit, therefore could not be analyzed for the primary outcome.
Dual Energy X-ray Absorptiometry (DXA) will be used to measuring bone mineral density (BMD).
Outcome measures
| Measure |
Teriparatide (Forteo)
n=27 Participants
Daily injection of Teriparatide for treatment of idiopathic osteoporosis
Teriparatide: Daily injection of 20 mcg teriparatide for the treatment of idiopathic osteoporosis for 24 months.
|
Placebo Saline Injection
n=13 Participants
Daily injection of saline placebo for 6 months, followed by 24 months of teriparatide treatment for idiopathic osteoporosis.
Saline Placebo: Daily injection of saline placebo for 6 months, followed by teriparatide treatment for 24 months.
|
|---|---|---|
|
Change in Lumbar Spine Bone Mineral Density (LS-BMD) on Active Medication
|
10.1 percentage of change
Standard Deviation 5.4
|
4.1 percentage of change
Standard Deviation 6.5
|
Adverse Events
Teriparatide (Forteo) (24 Months)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Saline Injection (6 Months)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Saline Injection (6-24 Months)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place