Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

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

Details

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

Criteria

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