Trial Outcomes & Findings for Enhancing Osteoporosis Therapy: Can We Open the Anabolic Window? (NCT NCT01166958)
NCT ID: NCT01166958
Last Updated: 2014-09-22
Results Overview
Serum CTX was measured at all study visits following the screening visit. The outcome data is an overall average and range from all time points.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
26 participants
Primary outcome timeframe
These were measured at the baseline and 1, 1.5, 2, 2.5, 3, 4, 5 and 6 month visits.
Results posted on
2014-09-22
Participant Flow
Participant milestones
| Measure |
Daily Teriparatide (Forteo)
Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
|
Monthly Cycles of Teriparatide Followed by Raloxifene
Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Daily Teriparatide (Forteo)
Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
|
Monthly Cycles of Teriparatide Followed by Raloxifene
Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Enhancing Osteoporosis Therapy: Can We Open the Anabolic Window?
Baseline characteristics by cohort
| Measure |
Daily Teriparatide (Forteo)
n=13 Participants
Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
|
Monthly Cycles of Teriparatide Followed by Raloxifene
n=13 Participants
Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=99 Participants
|
13 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Age, Continuous
|
67.7 years
n=99 Participants
|
66.2 years
n=107 Participants
|
67.0 years
n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: These were measured at the baseline and 1, 1.5, 2, 2.5, 3, 4, 5 and 6 month visits.Serum CTX was measured at all study visits following the screening visit. The outcome data is an overall average and range from all time points.
Outcome measures
| Measure |
Daily Teriparatide (Forteo)
n=13 Participants
Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
|
Monthly Cycles of Teriparatide Followed by Raloxifene
n=13 Participants
Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature.
|
|---|---|---|
|
Serum Markers of Skeletal Turnover (Serum CTX)
|
0.9887 ng/mL
Interval 0.5989 to 1.4042
|
0.5445 ng/mL
Interval 0.433 to 0.5838
|
PRIMARY outcome
Timeframe: These were measured at the baseline and 1, 1.5, 2, 2.5, 3, 4, 5 and 6 month visits.Serum P1NP was measured at all study visits following the screening visit. The outcome data is an overall average and range from all time points.
Outcome measures
| Measure |
Daily Teriparatide (Forteo)
n=13 Participants
Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
|
Monthly Cycles of Teriparatide Followed by Raloxifene
n=13 Participants
Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature.
|
|---|---|---|
|
Serum Markers of Skeletal Turnover (Serum P1NP)
|
128.7 mcg/L
Interval 61.3 to 177.9
|
83.8 mcg/L
Interval 52.8 to 110.8
|
SECONDARY outcome
Timeframe: BMD measured at the baseline, 3 month, and 6 month visits.Spine BMD was measured at the baseline, three month and six month visits. The outcome data is an overall average and range from all time points.
Outcome measures
| Measure |
Daily Teriparatide (Forteo)
n=13 Participants
Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
|
Monthly Cycles of Teriparatide Followed by Raloxifene
n=13 Participants
Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature.
|
|---|---|---|
|
Average Bone Mineral Density of the Spine at Baseline, 3 Months and 6 Months
|
0.9599 g/cm2
Interval 0.819 to 1.192
|
0.9006 g/cm2
Interval 0.718 to 1.094
|
SECONDARY outcome
Timeframe: BMD measured at the baseline, 3 month, and 6 month visits.Hip BMD was measured at the baseline, three month and six month visits. The outcome data is an overall average and range from all time points.
Outcome measures
| Measure |
Daily Teriparatide (Forteo)
n=13 Participants
Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
|
Monthly Cycles of Teriparatide Followed by Raloxifene
n=13 Participants
Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature.
|
|---|---|---|
|
Average Bone Mineral Density of the Proximal Femur (Hip) at Baseline, 3 Months and 6 Months
|
0.7951 g/cm2
Interval 0.677 to 0.939
|
0.7898 g/cm2
Interval 0.667 to 0.943
|
SECONDARY outcome
Timeframe: BMD measured at the baseline, 3 month, and 6 month visits.One-third radius BMD was measured at the baseline, three month and six month visits. The outcome data is an overall average and range from all time points.
Outcome measures
| Measure |
Daily Teriparatide (Forteo)
n=13 Participants
Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
|
Monthly Cycles of Teriparatide Followed by Raloxifene
n=13 Participants
Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature.
|
|---|---|---|
|
Average Bone Mineral Density of the One-third Radius at Baseline, 3 Months and 6 Months
|
0.6858 g/cm2
Interval 0.6 to 0.762
|
0.687 g/cm2
Interval 0.461 to 0.87
|
Adverse Events
Daily Teriparatide (Forteo)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Monthly Cycles of Teriparatide Followed by Raloxifene
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
Neil Binkley, MD
University of Wisconsin Osteoporosis Clinical Research Program
Phone: 608-265-6410
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place