Sequential Therapies After Osteoanabolic Treatment

Recruiting

• Conditions: Osteoporosis, Postmenopausal
• Interventions: Drug: Zoledronate; Drug: Denosumab; Drug: Teriparatide; Drug: Romosozumab

• Registration Number: NCT06164795
• Lead Sponsor: 424 General Military Hospital

Brief Summary

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 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...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2023-11-25
• Study First Submitted: 2023-11-29
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-02
• Last Update Submitted: 2023-12-09
• Study First Posted: 2023-12-11
• Last Update Posted: 2023-12-15
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Romo-Zol group	Zoledronate	Postmenopausal women treated with romosozumab for 12 months will receive a single zoledronate infusion (5mg) at 1 month after the last romosozumab dose
Romo-Dmab group	Denosumab	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
Romo-TPTD group	Teriparatide	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
TPTD-Zol group	Zoledronate	Postmenopausal women treated with teriparatide for 24 months will receive a single zoledronate infusion (5mg) at 1 month after the last romosozumab dose
TPTD-Romo group	Romosozumab	Postmenopausal women treated with teriparatide for 24 months will receive month injections of romosozumab for 12 months
TPTD-Dmab group	Denosumab	Postmenopausal women treated with teriparatide for 24 months will receive subcutaneous denosumab injections (60mg) bi-annually for 12 months

Primary Outcome Measures

Name	Time	Method
lumbar spine bone mineral density	baseline to 12 months	bone mineral density changes at the lumbar spine at 12 months measured by dual-energy absorptiometry (DXA)

Secondary Outcome Measures

Name	Time	Method
total hip bone mineral density	baseline to 12 months	bone mineral density changes at the total hip at 12 months measured by dual-energy absorptiometry (DXA)
femoral neck bone mineral density	baseline to 12 months	bone mineral density changes at the femoral neck at 12 months measured by dual-energy absorptiometry (DXA)
P1NP	baseline, 3 months, 6 months, 12 months	bone turnover (formation) marker
CTx	baseline, 3 months, 6 months, 12 months	bone turnover (resorption) marker
Fractures	12 months	incident fractures: vertebral (clinical and morphometric identified on VFA scans) and non-vertebral

Trial Locations

Locations (9)

Department of Medicine III and Center for Healthy Aging, Technische Universität Dresden; 🇩🇪 Dresden, Germany

251 Airforce & VA General Hospital; 🇬🇷 Athens, Greece

424 General Military Hospital; 🇬🇷 Thessaloniki, Greece

, KAT General Hospital; 🇬🇷 Athens, Greece

Fondazione IRCCS Cà Granda-Ospedale Maggiore Policlinico; 🇮🇹 Milan, Italy

Department of Medicine, Surgery and Neurosciences, University of Siena; 🇮🇹 Siena, Italy

First Department of Propaedeutic and Internal Medicine, Medical School, National and Kapodistrian University of Athens; 🇬🇷 Athens, Greece

Campus Bio-Medico University; 🇮🇹 Roma, Italy

University-Hospital S. Maria della Misericordia; 🇮🇹 Udine, Italy