DRUG
Teriparatide
teriparatide daily subcutaneous injection
Status
Completed
Phase
Phase 4
Enrollment
37
Locations
1
Results
Posted
Publications
0
Study 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.
Interventions
DRUG
teriparatide daily subcutaneous injection
DRUG
denosumab subcutaneous injection
Timeline
First posted
Jul 19, 2019
Study start
Sep 2, 2019
Primary completion
Apr 18, 2022
Study completion
Apr 18, 2022
Results posted
Aug 2, 2023
Registry updated
Aug 2, 2023
Outcomes
Cancellous Bone Formation Rate at Month 3
Time frame · 3 months after first dose of study drug
Cancellous bone formation rate at month 3 is calculated from the cancellous (trabecular) compartment of the iliac crest bone biopsy specimens. Bone formation rate (BFR/BS, mm3/mm2/day): amount of new bone formed in unit time per unit of bone surface. It is calculated by multiplying the mineralizing surface/bone surface (MS/BS) by the mineral apposition rate (MAR) - see below for how MS/BS and MAR are calculated. Mineralizing surface (MS/BS, %): is the percent of bone surface that displays a tetracycline label reflecting active mineralization. It is calculated as the double-labeled surface plus one half of the single-labeled surface and is expressed as a function of total bone surface. It is a measure of the proportion of bone surface upon which new mineralized bone was being deposited during the period of tetracycline labeling. Mineral apposition rate (MAR mm/day): is the mean distance between the double labels, divided by the time interval between them.
Not reported in the indexed record.
Eligibility
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
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Massachusetts General Hospital
Boston, Massachusetts, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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