Osteoporosis, Postmenopausal
Conditions
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 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
DRUGZoledronate
intravenous infusion
DRUGDenosumab
subcutaneous injection
DRUGTeriparatide
subcutaneous injection
DRUGRomosozumab
subcutaneous injection
daily subcutaneous injection
Sponsors
424 General Military Hospital
Laikο General Hospital, Athens
251 Hellenic Air Force & VA General Hospital
KAT Hospital of Athens
Campus Biomedico - Roma
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico Milano
Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy
University of Siena
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Greece, Italy
Contacts
CONTACTAthanasios D Anastasilakis, PhD
CONTACTJohn Carey, Prof
STUDY_CHAIRWillem Lems, Prof
ECTS Clinical Action Group
Outcome results
None listed