Evaluating treatments after osteoanabolic therapy for osteoporosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Athanasios D Anastasilakis, PhD
• Email: a.anastasilakis@gmail.com
• Phone: 2310381431

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.