Sequential Therapies After Osteoanabolic Treatment

NCT06164795 — Recruiting, 150 participants, 424 General Military Hospital

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

Registry	NCT06164795, acronym START
Status	Recruiting
Study type	Observational
Enrollment	150 (Estimated)
Sponsor	424 General Military Hospital (Other); collaborators: Laikο General Hospital, Athens, 251 Hellenic Air Force & VA General Hospital, KAT General Hospital, Campus Bio-Medico University, Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico Milano, Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy, University of Siena
Conditions	Osteoporosis, Postmenopausal
Interventions	Zoledronate, Denosumab, Teriparatide, Romosozumab, Abaloparatide Injection (80 mcg) (Drug)
Dates	start 2023-11-25, primary completion 2027-06-01 (estimated), completion 2027-12-01 (estimated), first posted 2023-12-11, last updated 2026-07-22
Locations	8 sites in Greece, Italy

-Summary

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

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+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

+Arms and interventions

Arm	Interventions	Description
Romo-Zol group	Drug: 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	Drug: 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-PTH group	Drug: Teriparatide; Drug: Abaloparatide Injection (80 mcg)	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
PTH-Zol group	Drug: Zoledronate	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
PTH-Dmab group	Drug: Denosumab	Postmenopausal women treated with teriparatide for 24 months or abaloparatide for 18 months will receive subcutaneous denosumab injections (60mg) bi-annually for 12 months
TPTD-Romo group	Drug: Romosozumab	Postmenopausal women treated with teriparatide for 24 months or abaloparatide for 18 months will receive month injections of romosozumab for 12 months

Zoledronate (Drug), also known as zoledronic acid; zolendronate: intravenous infusion
Denosumab (Drug), also known as Dmab: subcutaneous injection
Teriparatide (Drug), also known as TPTD: subcutaneous injection
Romosozumab (Drug), also known as Romo: subcutaneous injection
Abaloparatide Injection (80 mcg) (Drug): daily subcutaneous injection

+Outcome measures

Primary outcomes

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 outcomes

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)
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)
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

+Eligibility

Sex: Female, ages: 50 Years to 85 Years

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

+Locations (8)

Facility	City	Country	Status
251 Airforce & VA General Hospital	Athens	Greece	Recruiting
First Department of Propaedeutic and Internal Medicine, Medical School, National and Kapodistrian University of Athens	Athens	Greece	Recruiting
, KAT General Hospital	Athens	Greece	Recruiting
424 General Military Hospital	Thessaloniki	Greece	Recruiting
Fondazione IRCCS Cà Granda-Ospedale Maggiore Policlinico	Milan	Italy	Recruiting
Campus Bio-Medico University	Roma	Italy	Recruiting
Department of Medicine, Surgery and Neurosciences, University of Siena	Siena	Italy	Recruiting
University-Hospital S. Maria della Misericordia	Udine	Italy	Recruiting

+Investigators

Willem Lems, Prof, Study chair, ECTS Clinical Action Group