Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration

Mechanisms Underlying the Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration

The purpose of this study is to examine, via iliac crest bone biopsies, the mechanism of combined teriparatide and denosumab on the bone of postmenopausal osteoporotic women after 3 months of treatment.

Inclusion Criteria:

• women aged 45+
• postmenopausal
• osteoporotic with high risk of fracture

Exclusion Criteria:

• significant previous use of bone health modifying treatments
• known congenital or acquired bone disease other than osteoporosis
• significant renal disease, liver disease, cardiopulmonary disease, or psychiatric disease
• abnormal calcium or parathyroid hormone level
• serum vitamin D <20 ng/mL or >60ng/mL
• serum alkaline phosphatase above upper normal limit with no explanation
• anemia (hematocrit <32%)
• history of malignancy (except non-melanoma skin carcinoma), radiation therapy, or gouty arthritis
• history of urolithiasis within the last one year
• excessive alcohol use or substance abuse
• use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months
• extensive dental work involving extraction or dental implant within the past or upcoming 2 months
• known sensitivity to mammalian cell-derived drug products
• known contraindications to denosumab, teriparatide, or any of their excipients
• known contraindications to tetracycline, demeclocycline, or other antibiotics in this drug class
• continuous use of tetracycline for >1-month duration within the last 10 years