Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: Postmenopausal Osteoporosis

Treatments: Drug: Denosumab; Drug: Teriparatide

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04026256

5R01AR073191-04 (U.S. NIH Grant/Contract)

2018P002537

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: Female

Ages: 45+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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37 participants in 3 patient groups

Teriparatide only

Active Comparator group

Description:

daily subcutaneous injection teriparatide for 3 months

Treatment:

Drug: Teriparatide

Denosumab only

Active Comparator group

Description:

one dose of subcutaneous injection denosumab

Treatment:

Drug: Denosumab

Denosumab and teriparatide

Active Comparator group

Description:

daily subcutaneous injection teriparatide for 3 months plus one dose of subcutaneous injection denosumab

Treatment:

Drug: Teriparatide

Drug: Denosumab