Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration

Phase 4

Completed

• Conditions: Postmenopausal Osteoporosis
• Interventions: Drug: Teriparatide; Drug: Denosumab

• Registration Number: NCT04026256
• Lead Sponsor: Massachusetts General Hospital

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 treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-17
• Study First Submitted QC: 2019-07-17
• Study First Posted: 2019-07-19
• Study Start: 2019-09-02
• Primary Completion: 2022-04-18
• Study Completion: 2022-04-18
• Results First Submitted: 2023-07-25
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-01
• Last Update Submitted: 2023-08-01
• Results First Posted: 2023-08-02
• Last Update Posted: 2023-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 37

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Denosumab and teriparatide	Denosumab	daily subcutaneous injection teriparatide for 3 months plus one dose of subcutaneous injection denosumab
Teriparatide only	Teriparatide	daily subcutaneous injection teriparatide for 3 months
Denosumab only	Denosumab	one dose of subcutaneous injection denosumab
Denosumab and teriparatide	Teriparatide	daily subcutaneous injection teriparatide for 3 months plus one dose of subcutaneous injection denosumab

Primary Outcome Measures

Name	Time	Method
Cancellous Bone Formation Rate at Month 3	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States