Osteoporosis, PostmenopausalSTARTNCT06164795
Sequential Therapies After Osteoanabolic Treatment
An observational study of Osteoporosis, Postmenopausal, run by 424 General Military Hospital at 8 sites in 2 countries.
Trial summary
12-month prospective, open-label, multicenter, international, observational study evaluating sequential treatments after osteoanabolics Read more about this study
- Who is it for?
- Ages 50 to 85 years, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- Zoledronate, Denosumab and Teriparatide
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 25 Nov 2023to Dec 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Postmenopausal women treated with severe osteoporosis
Who may be able to join
- Postmenopausal women treated with severe osteoporosis completing their course with romosozumab or teriparatide
Who cannot join
- 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
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
John Carey, Prof contact
8 sites in 2 countries
Greece4 sites, 4 recruiting
- Recruiting
251 Airforce & VA General Hospital
Athens, 11525
Polyzois Makras, PhD, +302107463606, pmakras@gmail.com
- Recruiting
First Department of Propaedeutic and Internal Medicine, Medical School, National and Kapodistrian University of Athens
Athens, 11527
Maria P Yavropoulou, Consultant, +30 2132060800, myavropoulou@med.uoa.gr
- Recruiting
, KAT General Hospital
Athens, 14561
Symeon Tournis, PhD, +30 2132086000, stournis@med.uoa.gr
- Recruiting
424 General Military Hospital
Thessaloniki, 56429
Athanasios D Anastasilakis, PhD, +302310381697, a.anastasilakis@gmail.com
Stergios A Polyzos, PhD, +302310455780, stergios@endo.gr
Italy4 sites, 4 recruiting
- Recruiting
Fondazione IRCCS Cà Granda-Ospedale Maggiore Policlinico
Milan
Cristina Eller-Vainicher, eller.vainicher@gmail.com
Giorgia Grassi, MD
- Recruiting
Campus Bio-Medico University
Roma, 00128
Andrea Palermo, Ass Prof, A.Palermo@unicampus.it
Gaia Tabacco, PhD
- Recruiting
Department of Medicine, Surgery and Neurosciences, University of Siena
Siena, 53100
Luigi Gennari, prof, gennari@unisi.it
Daniela Merlotti
- Recruiting
University-Hospital S. Maria della Misericordia
Udine
Fabio Vescini, fabio.vescini@asufc.sanita.fvg.it
Antonio Salcuni
About this study
Official title: Efficacy of Sequential Therapies After Osteoanabolic Treatment in Postmenopausal Women With Severe Osteoporosis: the Sequential Treatment After Romosozumab and Teriparatide/Abaloparatide (START) Study
12-month prospective, open-label, multicenter, international, observational study evaluating sequential treatments after osteoanabolics
Read the 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
- Being tested
- Zoledronate, Denosumab, Teriparatide, Romosozumab, Abaloparatide Injection (80 mcg)
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZoledronateDrug
Also called zoledronic acid; zolendronate
intravenous infusion
DenosumabDrug
Also called Dmab
subcutaneous injection
TeriparatideDrug
Also called TPTD
subcutaneous injection
RomosozumabDrug
Also called Romo
subcutaneous injection
Abaloparatide Injection (80 mcg)Drug
daily subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Zoledronate | |
| 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 Receives: Drug: Denosumab | |
| 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 Receives: Drug: Teriparatide; Drug: Abaloparatide Injection (80 mcg) | |
| 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 Receives: Drug: Zoledronate | |
| 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 Receives: Drug: Denosumab | |
| 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 Receives: Drug: Romosozumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
lumbar spine bone mineral density
bone mineral density changes at the lumbar spine at 12 months measured by dual-energy absorptiometry (DXA)
Measured: baseline to 12 months
Secondary outcomes (5)
femoral neck bone mineral density
bone mineral density changes at the femoral neck at 12 months measured by dual-energy absorptiometry (DXA)
Measured: baseline to 12 months
total hip bone mineral density
bone mineral density changes at the total hip at 12 months measured by dual-energy absorptiometry (DXA)
Measured: baseline to 12 months
P1NP
bone turnover (formation) marker
Measured: baseline, 3 months, 6 months, 12 months
CTx
bone turnover (resorption) marker
Measured: baseline, 3 months, 6 months, 12 months
Fractures
incident fractures: vertebral (clinical and morphometric identified on VFA scans) and non-vertebral
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start25 Nov 2023
- Primary completion1 Jun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 424 General Military Hospital
- Sponsor type
- University, hospital or 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
- Responsible party
- Principal investigator, Athanasios D. Anastasilakis, 424 General Military Hospital
- Investigators
- Willem Lems, Prof, Study chair, ECTS Clinical Action Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164795
- Sponsor's protocol ID
- START
- Acronym
- START
- Status last verified
- Jul 2026
- First submitted
- 29 Nov 2023
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided