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Denosumab and Teriparatide Study (DATA-HD and DATA-EX)

Denosumab and Teriparatide Study (DATA-HD and DATA-EX)

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02176382
Acronym
DATA-HD
Enrollment
76
Registered
2014-06-27
Start date
2014-08-31
Completion date
2020-02-29
Last updated
2021-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopausal Osteoporosis

Brief summary

The aim of the study is to assess the effect of an antiresorptive medication in combination with standard dose or alternate dose teriparatide. The study extension will evaluate the effect of one-dose of zoledronic acid after the teriparatide/denosumab combination.

Interventions

DRUGdenosumab

denosumab subcutaneous injection

DRUGteriparatide

teriparatide daily subcutaneous injection

DRUGZoledronic acid

zoledronic acid infusion

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* women aged 45+ * postmenopausal * osteoporotic with high risk of fracture

Exclusion criteria

* no significant previous use of bone health modifying treatments

Design outcomes

Primary

MeasureTime frame
Percent Change From Baseline in Spine Bone Mineral Density by Dual X-ray Absorptiometry (DXA)Baseline and 42 months

Countries

United States

Participant flow

Participants by arm

ArmCount
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
35
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
34
Total69

Baseline characteristics

CharacteristicHigh Dose TeriparatideTotalStandard Dose Teriparatide
Age, Continuous67.0 years
STANDARD_DEVIATION 7.3
66.4 years
STANDARD_DEVIATION 7.1
65.9 years
STANDARD_DEVIATION 7
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants2 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
33 Participants67 Participants34 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants2 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
33 Participants66 Participants33 Participants
Sex: Female, Male
Female
34 Participants69 Participants35 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 390 / 37
other
Total, other adverse events
0 / 392 / 37
serious
Total, serious adverse events
9 / 392 / 37

Outcome results

Primary

Percent Change From Baseline in Spine Bone Mineral Density by Dual X-ray Absorptiometry (DXA)

Time frame: Baseline and 42 months

Population: Population includes those who completed a month 42 visit.

ArmMeasureValue (MEAN)Dispersion
Standard Dose TeriparatidePercent Change From Baseline in Spine Bone Mineral Density by Dual X-ray Absorptiometry (DXA)7.69 percent change in BMDStandard Deviation 4.66
High Dose TeriparatidePercent Change From Baseline in Spine Bone Mineral Density by Dual X-ray Absorptiometry (DXA)12.70 percent change in BMDStandard Deviation 5.54

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026