Sequential Therapies After Osteoanabolic Treatment (START)

December 9, 2023 updated by: Athanasios D. Anastasilakis, 424 General Military Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

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

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Dresden, Germany
  • Greece
      • Athens, Greece, 11527
        • Recruiting
        • First Department of Propaedeutic and Internal Medicine, Medical School, National and Kapodistrian University of Athens
        • Contact:
      • Athens, Greece, 14561
        • Not yet recruiting
        • , KAT General Hospital
        • Contact:
      • Athens, Greece, 11525
        • Recruiting
        • 251 Airforce & VA General Hospital
        • Contact:
      • Thessaloniki, Greece, 56429
        • Recruiting
        • 424 General Military Hospital
        • Contact:
        • Contact:
  • Italy
      • Milan, Italy
        • Not yet recruiting
        • Fondazione IRCCS Cà Granda-Ospedale Maggiore Policlinico
        • Contact:
        • Sub-Investigator:
          • Giorgia Grassi, MD
      • Roma, Italy, 00128
        • Not yet recruiting
        • Campus Bio-Medico University
        • Contact:
        • Contact:
          • Gaia Tabacco, PhD
        • Sub-Investigator:
          • Anda Naciu, PhD
        • Sub-Investigator:
          • Gaia Tabacco, PhD
      • Siena, Italy, 53100
        • Not yet recruiting
        • Department of Medicine, Surgery and Neurosciences, University of Siena
        • Contact:
        • Contact:
          • Daniela Merlotti
        • Sub-Investigator:
          • Daniela Merlotti
      • Udine, Italy
        • Not yet recruiting
        • University-Hospital S. Maria della Misericordia
        • Contact:
        • Sub-Investigator:
          • Antonio Salcuni

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Postmenopausal women treated with severe osteoporosis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Romo-Zol group
Postmenopausal women treated with romosozumab for 12 months will receive a single zoledronate infusion (5mg) at 1 month after the last romosozumab dose
Drug: Zoledronate
intravenous infusion
Other Names:
  • zoledronic acid; zolendronate
Romo-Dmab group
Postmenopausal women treated with romosozumab for 12 months will receive subcutaneous denosumab injections (60mg) bi-annually for 12 months starting at 1 month after the last romosozumab dose
Drug: Denosumab
subcutaneous injection
Other Names:
  • Dmab
Romo-TPTD group
Postmenopausal women treated with romosozumab for 12 months will receive daily injections of teriparatide 20μg for 12 months starting at 1 month after the last romosozumab dose
Drug: Teriparatide
subcutaneous injection
Other Names:
  • TPTD
TPTD-Zol group
Postmenopausal women treated with teriparatide for 24 months will receive a single zoledronate infusion (5mg) at 1 month after the last romosozumab dose
Drug: Zoledronate
intravenous infusion
Other Names:
  • zoledronic acid; zolendronate
TPTD-Dmab group
Postmenopausal women treated with teriparatide for 24 months will receive subcutaneous denosumab injections (60mg) bi-annually for 12 months
Drug: Denosumab
subcutaneous injection
Other Names:
  • Dmab
TPTD-Romo group
Postmenopausal women treated with teriparatide for 24 months will receive month injections of romosozumab for 12 months
Drug: Romosozumab
subcutaneous injection
Other Names:
  • Romo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
P1NP
Time Frame: baseline, 3 months, 6 months, 12 months
bone turnover (formation) marker
baseline, 3 months, 6 months, 12 months
CTx
Time Frame: baseline, 3 months, 6 months, 12 months
bone turnover (resorption) marker
baseline, 3 months, 6 months, 12 months
Fractures
Time Frame: 12 months
incident fractures: vertebral (clinical and morphometric identified on VFA scans) and non-vertebral
12 months
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)
baseline to 12 months
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)
baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

424 General Military Hospital

Investigators

  • Study Chair: Willem Lems, Prof, ECTS Clinical Action Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 29, 2023

First Submitted That Met QC Criteria

December 2, 2023

First Posted (Actual)

December 11, 2023

Study Record Updates

Last Update Posted (Actual)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 9, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • START

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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