Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption
| Status: | Completed |
|---|---|
| Conditions: | Osteoporosis, Postmenopausal Syndrome |
| Therapuetic Areas: | Endocrinology, Rheumatology |
| Healthy: | No |
| Age Range: | 45 - Any |
| Updated: | 12/2/2016 |
| Start Date: | January 2013 |
| End Date: | August 2014 |
The aim of the study is to assess the relative antiresorptive properties of 2 osteoporosis
medications when combined with teriparatide.
medications when combined with teriparatide.
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
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