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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06164795
- Acronym / sponsor ID
- START / START
- Conditions
- Osteoporosis, Postmenopausal
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- 424 General Military HospitalUniversity, 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
- Study start
- 25 Nov 2023 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Romo-Zol group | – | Drug: ZoledronatePostmenopausal 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: DenosumabPostmenopausal 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: ZoledronatePostmenopausal 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: DenosumabPostmenopausal 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: RomosozumabPostmenopausal women treated with teriparatide for 24 months or abaloparatide for 18 months will receive month injections of romosozumab for 12 months |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postmenopausal women treated with severe osteoporosis
Key inclusion criteria (1 listed)
- Postmenopausal women treated with severe osteoporosis completing their course with romosozumab or teriparatide
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZoledronateAlso: zoledronic acid; zolendronateintravenous infusion | Drug | PTH-Zol group, Romo-Zol group |
| DenosumabAlso: Dmabsubcutaneous injection | Drug | PTH-Dmab group, Romo-Dmab group |
| TeriparatideAlso: TPTDsubcutaneous injection | Drug | Romo-PTH group |
| RomosozumabAlso: Romosubcutaneous injection | Drug | TPTD-Romo group |
| Abaloparatide Injection (80 mcg)daily subcutaneous injection | Drug | Romo-PTH group |
Primary outcome
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)
5 secondary outcomes
femoral neck bone mineral density
Time frame: baseline to 12 months
total hip bone mineral density
Time frame: baseline to 12 months
P1NP
Time frame: baseline, 3 months, 6 months, 12 months
CTx
Time frame: baseline, 3 months, 6 months, 12 months
Fractures
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Carey, Prof contact
Willem Lems, Prof study chair
ECTS Clinical Action Group
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, Postmenopausal, run by 424 General Military Hospital at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Greece, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Athanasios D Anastasilakis, PhD (2310381431 ext. +30, a.anastasilakis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lumbar spine bone mineral density (time frame: baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026; AzTrials last refreshed its copy on 1 Nov 2026.