Sequential Therapies After Osteoanabolic Treatment

Osteoporosis, Postmenopausal Clinical Trial

— START  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06164795
• Other study ID #: START
• Status: Recruiting
• Start date: November 25, 2023
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: 424 General Military Hospital
• Contact: Athanasios D Anastasilakis, PhD
• Phone: 2310381431
• Email: a.anastasilakis[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

Drug:
• Zoledronate
intravenous infusion
• Denosumab
subcutaneous injection
• Teriparatide
subcutaneous injection
• Romosozumab
subcutaneous injection

Locations

Country	Name	City	State
Germany	Department of Medicine III and Center for Healthy Aging, Technische Universität Dresden	Dresden
Greece	, KAT General Hospital	Athens
Greece	251 Airforce & VA General Hospital	Athens
Greece	First Department of Propaedeutic and Internal Medicine, Medical School, National and Kapodistrian University of Athens	Athens
Greece	424 General Military Hospital	Thessaloniki
Italy	Fondazione IRCCS Cà Granda-Ospedale Maggiore Policlinico	Milan
Italy	Campus Bio-Medico University	Roma
Italy	Department of Medicine, Surgery and Neurosciences, University of Siena	Siena
Italy	University-Hospital S. Maria della Misericordia	Udine

Sponsors (1)

Lead Sponsor	Collaborator
424 General Military Hospital

Countries where clinical trial is conducted

Germany,  Greece,  Italy, 

Outcome

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