Rankings / Hormones & Endocrine
Romosozumab (Evenity)
Hormones & Endocrine · Sclerostin antibody (bone anabolic)
Tier B
High-risk evidence profile
Bottom line
Read Off Label grades Romosozumab (Evenity) as B (6.5/10) based on strong evidence, very high for bone benefit magnitude, and a med-high-risk safety profile.
Its high-risk evidence profile reflects a Safety score of 3.5/10; reported benefits and harms can differ by indication, dose, route, duration, and population.
Amgen/UCB.
Studied, labeled, or reported-use context: 210 mg SC monthly (two 105 mg injections at one visit) for 12 doses; followed by antiresorptive… — Rx; not individualized guidance.
What the evidence says
Amgen/UCB. Trials report large bone-density gains over a 12-month course, including comparisons with teriparatide. The cardiovascular warning and exclusion of patients with recent myocardial infarction or stroke are key limits on generalizability. ARCH 2017 showed CV signal vs alendronate; subsequent meta-analyses are mixed — class-wide caution remains.
Mechanism
Humanized monoclonal antibody binds and neutralizes sclerostin (SOST), the osteocyte-secreted Wnt-pathway inhibitor; concurrently increases bone formation AND decreases bone resorption (uniquely 'dual action' vs other osteoporosis drugs); 12-month treatment course
Studied, labeled, or reported dose & route
210 mg SC monthly (two 105 mg injections at one visit) for 12 doses; followed by antiresorptive (bisphosphonate or denosumab)
This records doses and routes described in studies, approved labeling, clinical practice, or documented use. It is not individualized guidance and does not establish safety; context changes with indication, formulation, health history, monitoring, and other medicines.
Citations
- PubMed · PMID 27641143
- PubMed · PMID 28892457
- PubMed · PMID 39579023
- ClinicalTrials.gov · NCT00896532
- PubMed · PMID 41303575
A link means the source informed this entry; it does not mean every claim on the page comes from that source. If a citation looks wrong or you want a claim re-checked, send a correction.
Common questions
- What does the evidence show about Romosozumab (Evenity)'s effects?
- Read Off Label rates the evidence for Romosozumab (Evenity) as Strong and the benefit magnitude as very high for bone, producing an overall grade of B (6.5/10). Amgen/UCB.
- What safety findings are reported for Romosozumab (Evenity)?
- Romosozumab (Evenity) has a med-high risk profile in the database. Med-High (boxed FDA warning for major adverse cardiovascular events — ARCH showed CV imbalance vs alendronate; injection-site reactions; hypocalcemia; serious infections rare) Legal status: Rx (FDA-approved 2019 for postmenopausal osteoporosis at high fracture risk).
- What does the low Safety score for Romosozumab (Evenity) represent?
- The Safety score is 3.5/10. It records the substantial harms described for one or more use contexts; the Benefit score, indication, dose, route, duration, population, and legal status remain separate parts of the evidence profile.
- What doses or routes are reported for Romosozumab (Evenity)?
- 210 mg SC monthly (two 105 mg injections at one visit) for 12 doses; followed by antiresorptive (bisphosphonate or denosumab) This is context from studies, approved labeling, clinical practice, or documented use; it is not individualized guidance and does not establish safety.
- How does Romosozumab (Evenity) work?
- Humanized monoclonal antibody binds and neutralizes sclerostin (SOST), the osteocyte-secreted Wnt-pathway inhibitor; concurrently increases bone formation AND decreases bone resorption (uniquely 'dual action' vs other osteoporosis drugs); 12-month treatment course
This is an independent synthesis of published research by a non-clinician. Scores are opinions supported by citations, not prescriptions. See the full disclaimer and methodology for how this score was produced and what it does and doesn't mean.