Sequential Therapies After Osteoanabolic Treatment

NCT06164795 | Recruiting DMC

• 1 other identifier: START
• Study Type: observational
• Target: 150
• Locations: 2 countries
• Sites: 8

Brief Summary

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

Conditions

Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (1)

• lumbar spine bone mineral density

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

  baseline to 12 months

Secondary Outcomes (5)

• femoral neck bone mineral density

  baseline to 12 months

• total hip bone mineral density

  baseline to 12 months

• P1NP

  baseline, 3 months, 6 months, 12 months

• CTx

  baseline, 3 months, 6 months, 12 months

• Fractures

  12 months

Study Arms (6)

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

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

Romo-PTH group

Postmenopausal women treated with romosozumab for 12 months will receive daily injections of teriparatide 20μg or abaloparatide 80μg for 12 months starting at 1 month after the last romosozumab dose

Drug: Teriparatide; Drug: Abaloparatide Injection (80 mcg)

PTH-Zol group

Postmenopausal women treated with teriparatide for 24 months or abaloparatide for 18 monthswill receive a single zoledronate infusion (5mg) at 1 month after the last romosozumab dose

Drug: Zoledronate

PTH-Dmab group

Postmenopausal women treated with teriparatide for 24 months or abaloparatide for 18 months will receive subcutaneous denosumab injections (60mg) bi-annually for 12 months

Drug: Denosumab

TPTD-Romo group

Postmenopausal women treated with teriparatide for 24 months or abaloparatide for 18 months will receive month injections of romosozumab for 12 months

Drug: Romosozumab

Interventions

Zoledronate DRUG

intravenous infusion

Also known as: zoledronic acid; zolendronate

PTH-Zol group; Romo-Zol group

Denosumab DRUG

subcutaneous injection

Also known as: Dmab

PTH-Dmab group; Romo-Dmab group

Teriparatide DRUG

subcutaneous injection

Also known as: TPTD

Romo-PTH group

Romosozumab DRUG

subcutaneous injection

Also known as: Romo

TPTD-Romo group

Abaloparatide Injection (80 mcg) DRUG

daily subcutaneous injection

Romo-PTH group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Gender Eligibility Details: Postmenopausal women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Postmenopausal women treated with severe osteoporosis

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• 424 General Military Hospital: lead

Study Sites (8)

251 Airforce & VA General Hospital

Athens, 11525, Greece

RECRUITING

First Department of Propaedeutic and Internal Medicine, Medical School, National and Kapodistrian University of Athens

Athens, 11527, Greece

RECRUITING

, KAT General Hospital

Athens, 14561, Greece

RECRUITING

424 General Military Hospital

Thessaloniki, 56429, Greece

RECRUITING

Fondazione IRCCS Cà Granda-Ospedale Maggiore Policlinico

Milan, Italy

RECRUITING

Campus Bio-Medico University

Roma, 00128, Italy

RECRUITING

Department of Medicine, Surgery and Neurosciences, University of Siena

Siena, 53100, Italy

RECRUITING

University-Hospital S. Maria della Misericordia

Udine, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum samples for bone markers measurements

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Zoledronic Acid; Denosumab; Teriparatide; romosozumab; Romo-A; abaloparatide

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides

Study Officials

• Willem Lems, Prof

  ECTS Clinical Action Group

  STUDY CHAIR

Central Study Contacts

Athanasios D Anastasilakis, PhD

CONTACT

2310381431; a.anastasilakis@gmail.com

John Carey, Prof

CONTACT

john.j.carey@universityofgalway.ie

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Endocrinology

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 11, 2023
• Study Start: November 25, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

IT (4); GR (4)