Phase 4
Completed N=34
Bone Modeling Effects of Combined Anabolic/Antiresorptive Administration
Source: ClinicalTrials.gov NCT04026256 ↗Enrolled (actual)
34
Serious AEs
5.9%
Results posted
Aug 2023
Primary outcomePrimary: Cancellous Bone Formation Rate at Month 3 — 0.13; 0.01; 0.06 mm3/mm2/day
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cancellous Bone Formation Rate at Month 3 |
0.13; 0.01; 0.06 | — |
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
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. Informational only — not medical advice.