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Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis

The Denosumab And Teriparatide Administration Study (DATA)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00926380
Acronym
DATA
Enrollment
94
Registered
2009-06-23
Start date
2009-06-30
Completion date
2016-12-31
Last updated
2018-06-29

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

Conditions

Osteoporosis

Keywords

osteoporosis, postmenopausal, denosumab, teriparatide, Forteo®, DXA, Bone Mineral Density, pQCT

Brief summary

The aim of this study is to determine whether denosumab (an FDA-approved osteoporosis therapy), in combination with teriparatide (an FDA-approved osteoporosis therapy), will increase bone mineral density more than either one alone in postmenopausal osteoporotic women.

Interventions

DRUGdenosumab

denosumab: 60 mg SC every 6 months

DRUGteriparatide

teriparatide: 20 mcg SC QD

Sponsors

Amgen
CollaboratorINDUSTRY
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
No

Inclusion criteria

Must satisfy A and B and C and D below: * (A) Women aged \> 55 * (B) Postmenopausal * (C) Osteoporotic with high risk of fracture

Exclusion criteria

* Confirmed serum alkaline phosphatase above upper normal limit with no explanation * Liver disease (AST or ALT \> 2 x upper normal limit). * Renal disease (serum creatinine \> 2.0 mg/dl). * Hypercalcemia (Ca \>10.5 mg/dL) * Elevated blood PTH (intact PTH \> 65 pg/ml) * Serum 25-OH vitamin D \< 20 ng/ml * HCT \< 32%. * History of malignancy (except basal cell carcinoma) or radiation therapy. * Significant cardiopulmonary disease including unstable coronary artery disease, stage D ACC/AHA heart failure or any other condition that the investigator deems may preclude the subject from participating safely or completing the protocol procedures. * Major psychiatric disease that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures. * Excessive alcohol use or substance abuse that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures. * Known congenital or acquired bone disease other than osteoporosis (including osteomalacia, hyperparathyroidism, Paget's disease) * Current use or use in the past 6 months of oral bisphosphonate * Current use or use within the past 3 months of estrogens, selective estrogen receptor modulators, or calcitonin. * Use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months. * Any current or previous use of strontium or any parenteral bisphosphonate. * Known sensitivity to mammalian cell-derived drug products. * Known sensitivity to teriparatide or any of its excipients.

Design outcomes

Primary

MeasureTime frame
Change in Spine Bone Density From Baseline to 2 YearsBaseline and 2 years

Countries

United States

Participant flow

Participants by arm

ArmCount
Denosumab ONLY
denosumab: denosumab: 60 mg SC every 6 months
33
Teriparatide (Forteo®) ONLY
teriparatide: teriparatide: 20 mcg SC QD
31
Denosumab and Teriparatide (Forteo®)
denosumab: denosumab: 60 mg SC every 6 months teriparatide: teriparatide: 20 mcg SC QD
30
Total94

Baseline characteristics

CharacteristicDenosumab ONLYTeriparatide (Forteo®) ONLYDenosumab and Teriparatide (Forteo®)Total
25-Hydroxyvitamin D (ng/mL)35.3 ng/mL
STANDARD_DEVIATION 10.5
31.2 ng/mL
STANDARD_DEVIATION 8.5
33.9 ng/mL
STANDARD_DEVIATION 11.8
33.5 ng/mL
STANDARD_DEVIATION 10.5
Age, Continuous66.3 years
STANDARD_DEVIATION 8.3
65.5 years
STANDARD_DEVIATION 7.9
65.9 years
STANDARD_DEVIATION 9
65.9 years
STANDARD_DEVIATION 8.3
Alkaline phosphatase concentration in serum (U/L)78.8 U/L
STANDARD_DEVIATION 16.8
75.8 U/L
STANDARD_DEVIATION 16.8
84.2 U/L
STANDARD_DEVIATION 20.8
79.6 U/L
STANDARD_DEVIATION 18.4
Body-mass index24.1 kg/m^2
STANDARD_DEVIATION 3.9
25.5 kg/m^2
STANDARD_DEVIATION 3.8
25.4 kg/m^2
STANDARD_DEVIATION 4.9
25.0 kg/m^2
STANDARD_DEVIATION 4.2
DXA Bone Density (g/cm^2) (Distal 1/3 of the radius shaft)0.602 g/cm^2
STANDARD_DEVIATION 0.082
0.612 g/cm^2
STANDARD_DEVIATION 0.069
0.613 g/cm^2
STANDARD_DEVIATION 0.07
0.609 g/cm^2
STANDARD_DEVIATION 0.073
DXA Bone Density (g/cm^2) (Femoral neck)0.641 g/cm^2
STANDARD_DEVIATION 0.086
0.643 g/cm^2
STANDARD_DEVIATION 0.061
0.642 g/cm^2
STANDARD_DEVIATION 0.067
0.642 g/cm^2
STANDARD_DEVIATION 0.071
DXA Bone Density (g/cm^2) (Posterior-anterior lumbar spine)0.866 g/cm^2
STANDARD_DEVIATION 0.088
0.823 g/cm^2
STANDARD_DEVIATION 0.111
0.856 g/cm^2
STANDARD_DEVIATION 0.131
0.848 g/cm^2
STANDARD_DEVIATION 0.112
DXA Bone Density (g/cm^2) (Total hip)0.766 g/cm^2
STANDARD_DEVIATION 0.1
0.757 g/cm^2
STANDARD_DEVIATION 0.068
0.759 g/cm^2
STANDARD_DEVIATION 0.073
0.761 g/cm^2
STANDARD_DEVIATION 0.081
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants0 Participants1 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
32 Participants31 Participants29 Participants92 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
History of fragility fracture12 Participants16 Participants10 Participants38 Participants
Osteocalcin (ng/mL)42.9 ng/mL
STANDARD_DEVIATION 19.4
49.0 ng/mL
STANDARD_DEVIATION 28.8
52.2 ng/mL
STANDARD_DEVIATION 29.9
47.8 ng/mL
STANDARD_DEVIATION 26.2
Previous oral bisphosphonate use12 Participants13 Participants10 Participants35 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
1 Participants0 Participants2 Participants3 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
31 Participants31 Participants28 Participants90 Participants
Region of Enrollment
United States
33 Participants31 Participants30 Participants94 Participants
Serum amino-terminal propeptide of type 1 procollagen (P1NP) (µg/L)45.7 µg/L
STANDARD_DEVIATION 16.7
46.0 µg/L
STANDARD_DEVIATION 19.5
49.3 µg/L
STANDARD_DEVIATION 20.9
47.1 µg/L
STANDARD_DEVIATION 19
Serum β-C-terminal telopeptide of type 1 collagen (CTX) (ng/mL)0.39 ng/mL
STANDARD_DEVIATION 0.21
0.36 ng/mL
STANDARD_DEVIATION 0.15
0.43 ng/mL
STANDARD_DEVIATION 0.17
0.39 ng/mL
STANDARD_DEVIATION 0.18
Sex: Female, Male
Female
33 Participants31 Participants30 Participants94 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
4 / 335 / 314 / 30
serious
Total, serious adverse events
1 / 332 / 311 / 30

Outcome results

Primary

Change in Spine Bone Density From Baseline to 2 Years

Time frame: Baseline and 2 years

ArmMeasureValue (MEAN)Dispersion
Denosumab ONLYChange in Spine Bone Density From Baseline to 2 Years8.3 percent changeStandard Error 3.4
Teriparatide (Forteo®) ONLYChange in Spine Bone Density From Baseline to 2 Years9.5 percent changeStandard Error 5.9
Denosumab and Teriparatide (Forteo®)Change in Spine Bone Density From Baseline to 2 Years12.9 percent changeStandard Error 5

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026