Evaluating treatments after osteoanabolic therapy for osteoporosis

Efficacy of Sequential Therapies After Osteoanabolic Treatment in Postmenopausal Women With Severe Osteoporosis: the Sequential Treatment After Romosozumab and Teriparatide/Abaloparatide (START) Study

This study is testing different follow-up treatments for Caucasian women with severe osteoporosis after they’ve finished a specific therapy to see which one helps improve their bone health the most.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 50 Years to 85 Years
• Sex: Female
• Sponsor: 424 General Military Hospital (other)
• Drugs / interventions: romosozumab, denosumab
• Locations: 8 sites (Athens and 7 other locations)
• Trial ID: NCT06164795 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the effectiveness of sequential treatments in Caucasian women with severe postmenopausal osteoporosis who have completed therapy with romosozumab or a PTH analog. Participants will be assigned to receive either zoledronate, denosumab, or teriparatide/abaloparatide based on their previous treatment. The study will monitor changes in bone mineral density (BMD) at the lumbar spine and other sites over 12 months, along with tracking bone turnover markers and incident fractures. It is a multicenter, international effort designed to provide insights into optimal post-osteoanabolic treatment strategies.

Who should consider this trial

Good fit: Ideal candidates are postmenopausal women with severe osteoporosis who have recently completed treatment with romosozumab or teriparatide.

Not a fit: Patients with other bone diseases, uncontrolled endocrine diseases, or those with certain medical conditions such as liver failure or cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment protocols for postmenopausal osteoporosis, enhancing bone health and reducing fracture risk.

How similar studies have performed: While this approach is observational, similar studies evaluating sequential therapies after osteoanabolic treatments have shown promise in improving patient outcomes.

Eligibility criteria

Inclusion Criteria:

• Postmenopausal women treated with severe osteoporosis completing their course with romosozumab or teriparatide

Exclusion Criteria:

* a bone disease other than postmenopausal osteoporosis
* use of medications other than romosozumab or teriparatide affecting bone metabolism during the last 12 months before entering the study
* creatinine clearance \<60 mL/min/1.73 m2
* liver failure
* any type of cancer
* uncontrolled endocrine diseases
* serum 25-hydroxy vitamin D (25-OHD) concentrations lower than 20 ng/mL (50 nmol/L)
* hypersensitivity to denosumab or zoledronate or teriparatide or romosozumab or any of the excipients

Where this trial is running

Athens and 7 other locations

• 251 Airforce & VA General Hospital — Athens, Greece (RECRUITING)
• First Department of Propaedeutic and Internal Medicine, Medical School, National and Kapodistrian University of Athens — Athens, Greece (RECRUITING)
• , KAT General Hospital — Athens, Greece (RECRUITING)
• 424 General Military Hospital — Thessaloniki, Greece (RECRUITING)
• Fondazione IRCCS Cà Granda-Ospedale Maggiore Policlinico — Milan, Italy (RECRUITING)
• Campus Bio-Medico University — Roma, Italy (RECRUITING)
• Department of Medicine, Surgery and Neurosciences, University of Siena — Siena, Italy (RECRUITING)
• University-Hospital S. Maria della Misericordia — Udine, Italy (RECRUITING)

Study contacts

• Study coordinator: Athanasios D Anastasilakis, PhD

Conditions: Osteoporosis, Postmenopausal