Trial Outcomes & Findings for Denosumab and Teriparatide Study (DATA-HD and DATA-EX) (NCT NCT02176382)
NCT ID: NCT02176382
Last Updated: 2021-02-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
76 participants
Primary outcome timeframe
Baseline and 42 months
Results posted on
2021-02-09
Participant Flow
Participant milestones
| Measure |
Standard Dose Teriparatide
teriparatide daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15
denosumab: denosumab subcutaneous injection
teriparatide: teriparatide daily subcutaneous injection
Zoledronic acid: zoledronic acid infusion
|
High Dose Teriparatide
teriparatide alternate dose daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15
denosumab: denosumab subcutaneous injection
teriparatide: teriparatide daily subcutaneous injection
Zoledronic acid: zoledronic acid infusion
|
|---|---|---|
|
DATA-HD Study
STARTED
|
39
|
37
|
|
DATA-HD Study
COMPLETED
|
31
|
29
|
|
DATA-HD Study
NOT COMPLETED
|
8
|
8
|
|
DATA-HD Extension
STARTED
|
27
|
26
|
|
DATA-HD Extension
COMPLETED
|
26
|
26
|
|
DATA-HD Extension
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Denosumab and Teriparatide Study (DATA-HD and DATA-EX)
Baseline characteristics by cohort
| Measure |
Standard Dose Teriparatide
n=35 Participants
teriparatide daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15
denosumab: denosumab subcutaneous injection
teriparatide: teriparatide daily subcutaneous injection
Zoledronic acid: zoledronic acid infusion
|
High Dose Teriparatide
n=34 Participants
teriparatide alternate dose daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15
denosumab: denosumab subcutaneous injection
teriparatide: teriparatide daily subcutaneous injection
Zoledronic acid: zoledronic acid infusion
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.9 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
67.0 years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
66.4 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
1 Participants
n=7 Participants
|
1 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
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
PRIMARY outcome
Timeframe: Baseline and 42 monthsPopulation: Population includes those who completed a month 42 visit.
Outcome measures
| Measure |
Standard Dose Teriparatide
n=26 Participants
teriparatide daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15
denosumab: denosumab subcutaneous injection
teriparatide: teriparatide daily subcutaneous injection
Zoledronic acid: zoledronic acid infusion
|
High Dose Teriparatide
n=26 Participants
teriparatide alternate dose daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15
denosumab: denosumab subcutaneous injection
teriparatide: teriparatide daily subcutaneous injection
Zoledronic acid: zoledronic acid infusion
|
|---|---|---|
|
Percent Change From Baseline in Spine Bone Mineral Density by Dual X-ray Absorptiometry (DXA)
|
7.69 percent change in BMD
Standard Deviation 4.66
|
12.70 percent change in BMD
Standard Deviation 5.54
|
Adverse Events
Standard Dose Teriparatide
Serious events: 9 serious events
Other events: 0 other events
Deaths: 0 deaths
High Dose Teriparatide
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Dose Teriparatide
n=39 participants at risk
teriparatide daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15
denosumab: denosumab subcutaneous injection
teriparatide: teriparatide daily subcutaneous injection
Zoledronic acid: zoledronic acid infusion
|
High Dose Teriparatide
n=37 participants at risk
teriparatide alternate dose daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15
denosumab: denosumab subcutaneous injection
teriparatide: teriparatide daily subcutaneous injection
Zoledronic acid: zoledronic acid infusion
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
wrist fracture
|
5.1%
2/39 • 3.5 years
|
2.7%
1/37 • 3.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
anal cancer
|
0.00%
0/39 • 3.5 years
|
2.7%
1/37 • 3.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
breast cancer
|
5.1%
2/39 • 3.5 years
|
0.00%
0/37 • 3.5 years
|
|
Musculoskeletal and connective tissue disorders
clavicle fracture
|
2.6%
1/39 • 3.5 years
|
0.00%
0/37 • 3.5 years
|
|
Musculoskeletal and connective tissue disorders
fibula avulsion fracture
|
2.6%
1/39 • 3.5 years
|
0.00%
0/37 • 3.5 years
|
|
Musculoskeletal and connective tissue disorders
humeral fracture
|
2.6%
1/39 • 3.5 years
|
0.00%
0/37 • 3.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
kidney cancer
|
2.6%
1/39 • 3.5 years
|
0.00%
0/37 • 3.5 years
|
|
Endocrine disorders
pancreatitis
|
2.6%
1/39 • 3.5 years
|
0.00%
0/37 • 3.5 years
|
|
Musculoskeletal and connective tissue disorders
rib fracture
|
2.6%
1/39 • 3.5 years
|
0.00%
0/37 • 3.5 years
|
|
Musculoskeletal and connective tissue disorders
shoulder dislocation
|
2.6%
1/39 • 3.5 years
|
0.00%
0/37 • 3.5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
throat cancer
|
2.6%
1/39 • 3.5 years
|
0.00%
0/37 • 3.5 years
|
|
Musculoskeletal and connective tissue disorders
vertebral fracture
|
2.6%
1/39 • 3.5 years
|
0.00%
0/37 • 3.5 years
|
Other adverse events
| Measure |
Standard Dose Teriparatide
n=39 participants at risk
teriparatide daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15
denosumab: denosumab subcutaneous injection
teriparatide: teriparatide daily subcutaneous injection
Zoledronic acid: zoledronic acid infusion
|
High Dose Teriparatide
n=37 participants at risk
teriparatide alternate dose daily subcutaneous injection (months 0-9) plus denosumab subcutaneous injection every 6 months (months 3-15) followed by zoledronic acid at month 15
denosumab: denosumab subcutaneous injection
teriparatide: teriparatide daily subcutaneous injection
Zoledronic acid: zoledronic acid infusion
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/39 • 3.5 years
|
5.4%
2/37 • 3.5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place