Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis (DATA)
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ClinicalTrials.gov Identifier: NCT00926380 |
Recruitment Status :
Completed
First Posted : June 23, 2009
Results First Posted : May 8, 2018
Last Update Posted : June 29, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoporosis | Drug: denosumab Drug: teriparatide | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 94 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Denosumab And Teriparatide Administration Study (DATA) |
Study Start Date : | June 2009 |
Actual Primary Completion Date : | December 2016 |
Actual Study Completion Date : | December 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: denosumab ONLY |
Drug: denosumab
denosumab: 60 mg SC every 6 months |
Experimental: teriparatide (Forteo®) ONLY |
Drug: teriparatide
teriparatide: 20 mcg SC QD
Other Name: Forteo® |
Experimental: denosumab and teriparatide (Forteo®) |
Drug: denosumab
denosumab: 60 mg SC every 6 months Drug: teriparatide teriparatide: 20 mcg SC QD
Other Name: Forteo® |
- Change in Spine Bone Density From Baseline to 2 Years [ Time Frame: Baseline and 2 years ]

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Ages Eligible for Study: | 45 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00926380
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Principal Investigator: | Benjamin Z Leder, MD | Massachusetts General Hospital | |
Principal Investigator: | Robert M Neer, MD | Massachusetts General Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Benjamin Leder, MD, Principal Investigator, MD, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00926380 |
Other Study ID Numbers: |
20080723 2009P000525 |
First Posted: | June 23, 2009 Key Record Dates |
Results First Posted: | May 8, 2018 |
Last Update Posted: | June 29, 2018 |
Last Verified: | May 2018 |
osteoporosis postmenopausal denosumab teriparatide |
Forteo® DXA Bone Mineral Density pQCT |
Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Metabolic Diseases |
Denosumab Teriparatide Bone Density Conservation Agents Physiological Effects of Drugs Calcium-Regulating Hormones and Agents |