Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration

Postmenopausal Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04026256
• Other study ID #: 2018P002537
• Secondary ID: 5R01AR073191-04
• Status: Completed
• Phase: Phase 4
• Start date: September 2, 2019
• Est. completion date: April 18, 2022

Study information

• Verified date: August 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: April 18, 2022
• Est. primary completion date: April 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years and older

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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Intervention

Drug:
• Teriparatide
teriparatide daily subcutaneous injection
• Denosumab
denosumab subcutaneous injection

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancellous Bone Formation Rate at Month 3	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.	3 months after first dose of study drug