Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption

Study Overview
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Brief Summary
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The aim of the study is to assess the relative antiresorptive properties of 2 osteoporosis medications when combined with teriparatide.

Official Title
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Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption

Conditions
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Postmenopausal Osteoporosis

Intervention / Treatment
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* Drug: Teriparatide 40-mcg subcutaneous injection
* Drug: Denosumab Injection
* Drug: Alendronate Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must satisfy A and B and C below: A. Women aged 45+ B. Postmenopausal C. Osteoporotic with high risk of fracture Exclusion Criteria: History of significant hepatic, renal, cardiovascular, malignant disease, or conditions with impaired immune system Current alcohol or substance abuse Major psychiatric disorders Abnormal calcium level, elevated PTH, vitamin D deficiency, or anemia Known congenital or acquired bone disease other than osteoporosis Current use or past use in the past 12 months of oral bisphosphonates Current use or use in the past 3 months of estrogens, selective estrogen receptor modulators, or calcitonin Use of oral or parenteral glucocorticoids for more than 14 days in the past 6 months Any current or previous use of strontium or intravenous bisphosphonates Sensitivity to cell-derived drug products or teriparatide Extensive dental work involving dental extraction or dental implant within the past 2 months or in the upcoming 2 months Inability to sit upright for 30 minutes Esophageal abnormalities

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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Accepts Healthy Volunteers

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 |
| --- | --- |
| Active Comparator: Denosumab 60mg subcutaneous injection<br>Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit. | Drug: Teriparatide 40-mcg subcutaneous injection<br> <br> * Other names: Forteo®;Drug: Denosumab Injection<br>* One-time Denosumab injection<br>|
| Active Comparator: Alendronate 70mg weekly x 8 weeks<br>Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit. | Drug: Teriparatide 40-mcg subcutaneous injection<br> <br> * Other names: Forteo®;Drug: Alendronate Oral Tablet<br>* weekly alendronate for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Turnover Marker (Blood Sample) | The primary outcome was the between-group difference in the teriparatide-induced change in serum c-telopeptide from baseline to week 8. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoporosis, postmenopausal, denosumab, teriparatide, alendronate, Forteo®, Prolia®