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Recruiting NCT06164795

Sequential Therapies After Osteoanabolic Treatment

— Observational Osteoporosis, Postmenopausal

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Zoledronate, Denosumab, Teriparatide, Romosozumab.
Who it may be relevant to
Registry conditions: Osteoporosis, Postmenopausal. Basic parameters: 50 years — 85 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Greece, Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

12-month prospective, open-label, multicenter, international, observational study evaluating sequential treatments after osteoanabolics

Detailed description

Caucasian women with severe postmenopausal osteoporosis who have completed their course with romosozumab or a PTH analog will be assigned to one of the following 3 options: i) zoledronate 5mg infusion or ii) denosumab subcutaneous injections or iii) teriparatide or abaloparatide (for those previously treated with romosozumab) or romosozumab (for those previously treated with teriparatide or abaloparatide).

Endpoints: Primary: BMD changes at the lumbar spine at 12 months. Secondary: i) BMD changes at the non-dominant femoral neck and total hip at 12 and 24 months; ii) changes at levels of bone turnover markers throughout the study; iii) incident fractures: vertebral (clinical and morphometric identified on VFA scans) and non-vertebral

Interventions

  • Drug Zoledronate
    intravenous infusion
  • Drug Denosumab
    subcutaneous injection
  • Drug Teriparatide
    subcutaneous injection
  • Drug Romosozumab
    subcutaneous injection
  • Drug Abaloparatide Injection (80 mcg)
    daily subcutaneous injection

Primary outcome measures

  • lumbar spine bone mineral density [Time frame: baseline to 12 months]
Secondary outcome measures (5)
  • femoral neck bone mineral density [Time frame: baseline to 12 months]
  • total hip bone mineral density [Time frame: baseline to 12 months]
  • P1NP [Time frame: baseline, 3 months, 6 months, 12 months]
  • CTx [Time frame: baseline, 3 months, 6 months, 12 months]
  • Fractures [Time frame: 12 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Greece · 4 centers
  • 251 Airforce & VA General Hospital — Athens
  • First Department of Propaedeutic and Internal Medicine, Medical School, National and Kapod — Athens
  • , KAT General Hospital — Athens
  • 424 General Military Hospital — Thessaloniki
Italy · 4 centers
  • Fondazione IRCCS Cà Granda-Ospedale Maggiore Policlinico — Milan
  • Campus Bio-Medico University — Roma
  • Department of Medicine, Surgery and Neurosciences, University of Siena — Siena
  • University-Hospital S. Maria della Misericordia — Udine

Identifiers

NCT: NCT06164795 · START

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗