Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06164795

Sequential Therapies After Osteoanabolic Treatment

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

50 year–85 year

Sex eligibility

Female

Study type

Observational

Primary location

, KAT General Hospital, Athens, Greece

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zoledronate

Drug

intravenous infusion

Other names: zoledronic acid; zolendronate

Denosumab

Drug

subcutaneous injection

Other names: Dmab

Teriparatide

Drug

subcutaneous injection

Other names: TPTD

Romosozumab

Drug

subcutaneous injection

Other names: Romo

Abaloparatide Injection (80 mcg)

Drug

daily subcutaneous injection

Primary outcomes

  1. lumbar spine bone mineral density

    Time frame: baseline to 12 months

    bone mineral density changes at the lumbar spine at 12 months measured by dual-energy absorptiometry (DXA)

Secondary outcomes

  1. femoral neck bone mineral density

    Time frame: baseline to 12 months

    bone mineral density changes at the femoral neck at 12 months measured by dual-energy absorptiometry (DXA)

  2. total hip bone mineral density

    Time frame: baseline to 12 months

    bone mineral density changes at the total hip at 12 months measured by dual-energy absorptiometry (DXA)

  3. P1NP

    Time frame: baseline, 3 months, 6 months, 12 months

    bone turnover (formation) marker

  4. CTx

    Time frame: baseline, 3 months, 6 months, 12 months

    bone turnover (resorption) marker

  5. Fractures

    Time frame: 12 months

    incident fractures: vertebral (clinical and morphometric identified on VFA scans) and non-vertebral

Study contacts

Contact information is provided by the study sponsor or research team.

Athanasios D Anastasilakis, PhD

CONTACT

[email protected]

2310381431 ext. +30

John Carey, Prof

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

424 General Military Hospital

Other

Collaborators

  • 251 Hellenic Air Force & VA General Hospital
  • Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy
  • Campus Bio-Medico University
  • Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico Milano
  • KAT Hospital of Athens
  • Laikο General Hospital, Athens
  • University of Siena

Registry information

Official study title

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

Acronym: START

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Dec 11, 2023
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.