Phase 4 N=34 Randomized Single-blind Other

Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration

Postmenopausal Osteoporosis

Bottom Line

View on ClinicalTrials.gov: NCT04026256 ↗

Enrolled (actual)

Serious AEs

5.9%

Results posted

Aug 2023

Primary outcome: Primary: Cancellous Bone Formation Rate at Month 3 — 0.13; 0.01; 0.06 mm3/mm2/day

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Teriparatide (Drug); Denosumab (Drug)
Age: Adult, Older Adult · 45+ yrs
Sex: Female
Sponsor: Massachusetts General Hospital
Primary completion: Apr 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Cancellous Bone Formation Rate at Month 3	0.13; 0.01; 0.06	—

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.

Eligibility Criteria

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 60ng/mL
serum alkaline phosphatase above upper normal limit with no explanation
anemia (hematocrit 1-month duration within the last 10 years

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04026256). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.