DRUG
Zoledronate
intravenous infusion
Sequential Therapies After Osteoanabolic Treatment
Status
Recruiting
Phase
Not applicable
Enrollment
150
Locations
8
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
12-month prospective, open-label, multicenter, international, observational study evaluating sequential treatments after osteoanabolics
Full 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
Interventions
Treatment arms and agents.
DRUG
Denosumab
subcutaneous injection
DRUG
Teriparatide
subcutaneous injection
DRUG
Romosozumab
subcutaneous injection
DRUG
Abaloparatide Injection (80 mcg)
daily subcutaneous injection
Timeline
From registration to results.
First posted
Dec 11, 2023
Study start
Nov 25, 2023
Primary completion
Jun 1, 2027
Study completion
Dec 2027
Results posted
Not reported
Registry updated
Jul 22, 2026
Outcomes
What the study measures.
Primary outcomes
lumbar spine bone mineral density
Time frame · 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
Time frame · 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
Time frame · baseline to 12 months
bone mineral density changes at the total hip at 12 months measured by dual-energy absorptiometry (DXA)
P1NP
Time frame · baseline, 3 months, 6 months, 12 months
bone turnover (formation) marker
CTx
Time frame · baseline, 3 months, 6 months, 12 months
bone turnover (resorption) marker
Fractures
Time frame · 12 months
incident fractures: vertebral (clinical and morphometric identified on VFA scans) and non-vertebral
Eligibility
Who can take part.
- Minimum age
- 50 Years
- Maximum age
- 85 Years
- Sex
- FEMALE
- Healthy volunteers
- No
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
Study locations
8 registered sites.
Greece · Italy. Showing up to 24 locations stored in the fast local snapshot.
251 Airforce & VA General Hospital
Athens, Greece
First Department of Propaedeutic and Internal Medicine, Medical School, National and Kapodistrian University of Athens
Athens, Greece
, KAT General Hospital
Athens, Greece
424 General Military Hospital
Thessaloniki, Greece
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, Italy
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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