NCT06164795

Sequential Therapies After Osteoanabolic Treatment

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: 424 General Military Hospital · Academic / Other
• Sex: Female
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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 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

Conditions

• Osteoporosis, Postmenopausal

Interventions

Type	Name	Description
DRUG	Zoledronate	intravenous infusion
DRUG	Denosumab	subcutaneous injection
DRUG	Teriparatide	subcutaneous injection
DRUG	Romosozumab	subcutaneous injection
DRUG	Abaloparatide Injection (80 mcg)	daily subcutaneous injection

Timeline

• Start date: 2023-11-25
• Primary completion: 2026-12-01
• Completion: 2027-05-01
• First posted: 2023-12-11
• Last updated: 2025-04-27

Locations

8 sites across 2 countries: Greece, Italy