Denosumab, Teriparatide or Both for the Treatment of Postmenopausal Osteoporosis

Study Overview
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Brief Summary
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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.

Official Title
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The Denosumab And Teriparatide Administration Study (DATA)

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: denosumab
* Drug: teriparatide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: denosumab ONLY<br> | Drug: denosumab<br>* denosumab: 60 mg SC every 6 months<br>|
| Experimental: teriparatide (Forteo®) ONLY<br> | Drug: teriparatide<br>* teriparatide: 20 mcg SC QD<br>* Other names: Forteo®;|
| Experimental: denosumab and teriparatide (Forteo®)<br> | Drug: denosumab<br>* denosumab: 60 mg SC every 6 months<br>Drug: teriparatide<br>* teriparatide: 20 mcg SC QD<br>* Other names: Forteo®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Spine Bone Density From Baseline to 2 Years |  | Baseline and 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoporosis, pQCT, postmenopausal, denosumab, teriparatide, Forteo®, DXA, Bone Mineral Density