Trial · Observational
RecruitingPhase not statedRegistry dataSequential Therapies After Osteoanabolic Treatment
Short name START
Overview
- Status
- Recruiting
- Phase
- Phase not stated
- Enrollment
- 150 participants (estimated)
- Sponsor
- 424 General Military Hospital · Other
- Design
- Not stated
- Countries
2 countries
Greece, Italy
- Start
- 25 Nov 2023
- Primary completion
- 1 Jun 2027 (estimated)
- Completion
- Dec 2027 (estimated)
- First posted
- 11 Dec 2023
- Last update posted
- 22 Jul 2026
- Conditions
- Osteoporosis, Postmenopausal
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph –
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
12-month prospective, open-label, multicenter, international, observational study evaluating sequential treatments after osteoanabolics
Interventions
- ZoledronateDrug
- DenosumabDrug
- TeriparatideDrug
- RomosozumabDrug
- Abaloparatide Injection (80 mcg)Drug
Arms6
Other
Romo-Zol group
Postmenopausal women treated with romosozumab for 12 months will receive a single zoledronate infusion (5mg) at 1 month after the last romosozumab dose
Other
Romo-Dmab group
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
Other
Romo-PTH group
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
Other
PTH-Zol group
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
Other
PTH-Dmab group
Postmenopausal women treated with teriparatide for 24 months or abaloparatide for 18 months will receive subcutaneous denosumab injections (60mg) bi-annually for 12 months
Other
TPTD-Romo group
Postmenopausal women treated with teriparatide for 24 months or abaloparatide for 18 months will receive month injections of romosozumab for 12 months
Primary outcomes1
Outcomes the sponsor listed as primary.
lumbar spine bone mineral density
Time frame · baseline to 12 months
Registry description
bone mineral density changes at the lumbar spine at 12 months measured by dual-energy absorptiometry (DXA)
Secondary outcomes(5)
femoral neck bone mineral density
Time frame · baseline to 12 months
Registry description
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
Registry description
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
Registry description
bone turnover (formation) marker
CTx
Time frame · baseline, 3 months, 6 months, 12 months
Registry description
bone turnover (resorption) marker
Fractures
Time frame · 12 months
Registry description
incident fractures: vertebral (clinical and morphometric identified on VFA scans) and non-vertebral
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 50 Years up to 85 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
PepBank is a research reference. Talk to a doctor before you use any peptide.