Status:
COMPLETED
Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Postmenopausal Osteoporosis
Eligibility:
FEMALE
45+ years
Phase:
PHASE4
Brief 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 treatmen...
Eligibility Criteria
Inclusion
- women aged 45+
- postmenopausal
- osteoporotic with high risk of fracture
Exclusion
- 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
Key Trial Info
Start Date :
September 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2022
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04026256
Start Date
September 2 2019
End Date
April 18 2022
Last Update
August 2 2023
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114