Acute Effect of Teriparatide With Bisphosphonate or Denosumab on Bone Resorption

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Alendronate; Denosumab; Diphosphonates; Teriparatide

Criteria

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