Osteoporosis, PostmenopausalNCT07734922
High-Intensity Laser Therapy and Physiotherapy for Bone Health in Postmenopausal Women: A Randomized Trial
A study testing High-Intensity Laser Therapy and Standardised Physiotherapy Programme in people with Osteoporosis, Postmenopausal and Osteopenia, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
The goal of this clinical trial is to learn if adding high-intensity laser therapy (HILT) to a physiotherapy programme helps bone health in women after menopause who have low bone density (osteopenia or osteoporosis). It also looks at safety and quality of life. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal, Osteopenia
- What is being tested?
- High-Intensity Laser Therapy and Standardised Physiotherapy Programme
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteRomania
- Study dates
- 27 Jul 2026to 28 Feb 2027
- Phase
- Interventional
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women Osteopenia or osteoporosis diagnosed by DXA (T-score below -1.0) Age 50 to 70 years Body mass index (BMI) between 18.5 and 30 Provides written informed consent
Who cannot join
- History of fractures Use of agents that may interfere with bone metabolism (e.g., bisphosphonates, glucocorticoids, hormone therapy) Severe comorbidities or decompensation of pre-existing conditions Recent physiotherapy (within the past 3 months) Rheumatologic diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus) High-dose calcium or vitamin D supplementation Contraindications to laser therapy (cancer, active bleeding or bleeding disorders, acute infections, photosensitivity, pregnancy, implanted electronic devices, or other conditions that could interfere with laser treatment)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site
Clinical Rehabilitation Hospital
Cluj-Napoca, Cluj, 400347
Viorela Mihaela Ciortea, MD, PhD, +40 264 207 021, viorela.ciortea@umfcluj.ro
Titus Vari, MD
About this study
Official title: The Effects of High-Intensity Laser Therapy Combined With Physiotherapy on Bone Turnover and Bone Mineral Density in Postmenopausal Women With Osteopenia or Osteoporosis: A Randomized Controlled Trial
The goal of this clinical trial is to learn if adding high-intensity laser therapy (HILT) to a physiotherapy programme helps bone health in women after menopause who have low bone density (osteopenia or osteoporosis). It also looks at safety and quality of life.
The main questions it aims to answer are:
Read more
Does adding high-intensity laser therapy change a blood marker of bone formation called P1NP? Does adding high-intensity laser therapy improve participants' quality of life? Researchers will compare a group that gets physiotherapy plus real laser therapy with a group that gets physiotherapy plus a sham laser (a look-alike treatment that gives no real laser energy). This shows if the laser itself makes a difference.
Participants will:
Do the same physiotherapy programme, 3 times a week for 4 weeks Get either real or sham laser therapy at each session Give blood samples before and after treatment to measure the bone marker Fill in two quality-of-life questionnaires before and after treatment Have one bone density scan (DXA) at the start to check they can take part
Read the detailed description
Bone loss accelerates after menopause because of the decline in oestrogen, raising the risk of progression from osteopenia to osteoporosis and of fractures. Current medication options are largely preventive and have limitations. High-intensity laser therapy (HILT) combined with physiotherapy is a non-invasive physical treatment that may stimulate bone formation with a favourable safety profile, but robust evidence in postmenopausal bone health is limited.
This is a randomised, double-blind, placebo (sham)-controlled, parallel-group interventional trial with two equal arms. A standardised physiotherapy programme is delivered identically in both arms as a background co-intervention, so the comparison isolates the added effect of active HILT versus sham.
Randomisation uses permuted blocks of four with 1:1 allocation, concealed with sealed opaque envelopes. Participants, the physiotherapist, the outcome assessor and the statistician are all blinded to allocation.
Intervention parameters: pulsed HILT in the near-infrared spectrum, 7 W, 5 J/cm², applied over the lumbar region (L1-L5) with a scanning handpiece for approximately 150 seconds per session, three sessions per week for four weeks. The sham arm follows an identical procedure with a device that delivers no therapeutic laser energy.
The bone-formation marker P1NP is measured in peripheral blood by ELISA (ng/mL). To avoid the confounding effect of acute exercise on bone turnover markers, the post-treatment sample is collected 72 hours (minimum 48 hours) after the last physiotherapy session, before any further physical activity, and all samples are analysed in a single batch.
Analyses follow the intention-to-treat principle on all randomised participants, with a per-protocol analysis as a supportive check. For each measure, the change from baseline is compared between arms using parametric or non-parametric tests as appropriate, with results reported as effect sizes and 95% confidence intervals. Safety is monitored throughout the treatment sessions.
- Conditions
- Osteoporosis, Postmenopausal, Osteopenia
- Being tested
- High-Intensity Laser Therapy, Sham Laser, Standardised Physiotherapy Programme
- Keywords
- High-Intensity Laser Therapy, Laser Therapy, Exercise Therapy, Physical Therapy Modalities, Bone Remodeling, Bone Density, Procollagen Type I N-Terminal Propeptide, Menopause, Quality of Life
- Medical subject headings
- Osteoporosis, Postmenopausal, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Laser TherapyDevice
Also called HILT
Pulsed near-infrared laser, 7 W, 5 J/cm², applied over the lumbar spine (L1-L5) with a scanning handpiece for about 150 seconds per session, three sessions per week for four weeks (12 sessions total). Delivered in the experimental arm only.
Sham LaserDevice
Also called Placebo laser
A sham device identical in appearance and operation to the active laser but delivering no therapeutic energy. Applied on the same schedule: about 150 seconds per session over the lumbar spine (L1-L5), three sessions per week for four weeks. Delivered in the control arm only, to preserve blinding
Standardised Physiotherapy ProgrammeBehavioural
Also called Kinesiotherapy
A standardised physiotherapy (exercise) programme delivered identically in both arms as a background co-intervention. The programme is the same in content, frequency and duration for all participants, so the comparison isolates the added effect of the active laser versus sham.
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Laser Therapy + Physiotherapy | Experimental | Participants receive a standardised physiotherapy programme plus active high-intensity laser therapy (HILT). HILT is pulsed near-infrared laser, 7 W, 5 J/cm², applied over the lumbar spine (L1-L5) with a scanning handpiece for about 150 seconds per session, three sessions per week for four weeks (12 sessions total). Receives: Device: High-Intensity Laser Therapy; Behavioral: Standardised Physiotherapy Programme |
| Sham Laser + Physiotherapy | Sham comparator | Participants receive the same standardised physiotherapy programme plus a sham laser. The sham device looks and operates identically to the active laser but delivers no therapeutic energy. It follows the same schedule: about 150 seconds per session over the lumbar spine (L1-L5), three sessions per week for four weeks (12 sessions total). Receives: Device: Sham Laser; Behavioral: Standardised Physiotherapy Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in serum procollagen type I N-terminal propeptide (P1NP)
P1NP is a marker of bone formation, measured in peripheral blood by enzyme-linked immunosorbent assay (ELISA) and reported in ng/mL. The post-intervention sample is collected 72 hours (minimum 48 hours) after the last physiotherapy session, before any further physical activity, and all samples are analysed in a single batch.
Measured: Baseline and end of the 4-week intervention
Change from baseline in health-related quality of life (Short Form-36, SF-36)
SF-36 is a general health-related quality-of-life questionnaire. Scores range from 0 to 100, with higher scores indicating better quality of life.
Measured: Baseline and end of the 4-week intervention
Change from baseline in osteoporosis-specific quality of life (Qualeffo-41)
Qualeffo-41 is a quality-of-life questionnaire specific to osteoporosis. Total scores range from 0 to 100; higher scores indicate poorer quality of life.
Measured: Baseline and end of the 4-week intervention
Secondary outcomes (1)
Number of participants with adverse events
Adverse events are monitored throughout the treatment sessions and recorded by type, severity and relationship to the intervention.
Measured: Throughout the 4-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start27 Jul 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel arms with 1:1 allocation. A standardised physiotherapy programme is delivered identically in both arms as a background co-intervention; the experimental arm additionally receives active high-intensity laser therapy and the control arm a sham laser.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Viorela Mihaela Ciortea, Iuliu Hatieganu University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734922
- Sponsor's protocol ID
- NR. AVZ 4/13 IAN 2026
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coroleuca R, Filipoiu FM, Cherecheanu AP, Enyedi M, Bucsan R, Bostan M, Coroleuca CA, Ladea L, Vrinceanu D, Moraru OE, Iancu R. Laser Scanning Morphometric Measurements of the Main Orbital Communications in Dry Human Skulls. Diagnostics (Basel). 2024 Sep 29;14(19):2168. doi: 10.3390/diagnostics14192168.
PubMed 39410572Fallahnezhad S, Jajarmi V, Shahnavaz S, Amini A, Ghoreishi SK, Kazemi M, Chien S, Bayat M. Improvement in viability and mineralization of osteoporotic bone marrow mesenchymal stem cell through combined application of photobiomodulation therapy and oxytocin. Lasers Med Sci. 2020 Apr;35(3):557-566. doi: 10.1007/s10103-019-02848-8. Epub 2019 Aug 9.
PubMed 31399862Lee DO, Hong YH, Cho MK, Choi YS, Chun S, Chung YJ, Hong SH, Hwang KR, Kim J, Kim H, Lee DY, Lee SR, Park HT, Seo SK, Shin JH, Song JY, Yi KW, Paik H, Lee JY. The 2024 Guidelines for Osteoporosis - Korean Society of Menopause: Part I. J Menopausal Med. 2024 Apr;30(1):1-23. doi: 10.6118/jmm.24000. No abstract available.
PubMed 38714490Abo Elyazed TI, Al-Azab IM, Abd El-Hakim AAE, Elkady SM, Afifi RMM, Obaya HE. Effect of high-intensity laser therapy versus shockwave therapy on selected outcome measures in osteoporotic long-term hemiparetic patients: a randomized control trial. J Orthop Surg Res. 2023 Sep 2;18(1):653. doi: 10.1186/s13018-023-04141-5.
PubMed 37660042Alayat MSM, Abdel-Kafy EM, Thabet AAM, Abdel-Malek AS, Ali TH, Header EA. Long-Term Effect of Pulsed Nd-YAG Laser Combined with Exercise on Bone Mineral Density in Men with Osteopenia or Osteoporosis: 1 Year of Follow-Up. Photomed Laser Surg. 2018 Feb;36(2):105-111. doi: 10.1089/pho.2017.4328. Epub 2017 Oct 25.
PubMed 29068756Macedo P, Cavalcante A, Fernandes S, Salustiano M, Lima M, Jerez-Roig J, Camara S. Association between menopausal status and physical function: A systematic review protocol. PLoS One. 2023 Jan 24;18(1):e0280786. doi: 10.1371/journal.pone.0280786. eCollection 2023.
PubMed 36693069
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of High-Intensity Laser Therapy Combined With Physiotherapy on Bone Turnover and Bone Mineral Density in Postmenopausal Women With Osteopenia or Osteoporosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07734922
- Acronym / sponsor ID
- NR. AVZ 4/13 IAN 2026
- Conditions
- Osteoporosis, Postmenopausal, Osteopenia
- Keywords
- High-Intensity Laser Therapy, Laser Therapy, Exercise Therapy, Physical Therapy Modalities, Bone Remodeling, Bone Density, Procollagen Type I N-Terminal Propeptide, Menopause
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 27 Jul 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 29 Jul 2026 (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.
The goal of this clinical trial is to learn if adding high-intensity laser therapy (HILT) to a physiotherapy programme helps bone health in women after menopause who have low bone density (osteopenia or osteoporosis). It also looks at safety and quality of life.
The main questions it aims to answer are:
Does adding high-intensity laser therapy change a blood marker of bone formation called P1NP? Does adding high-intensity laser therapy improve participants' quality of life? Researchers will compare a group that gets physiotherapy plus real laser therapy with a group that gets physiotherapy plus a sham laser (a look-alike treatment that gives no real laser energy). This shows if the laser itself makes a difference.
Participants will:
Do the same physiotherapy programme, 3 times a week for 4 weeks Get either real or sham laser therapy at each session Give blood samples before and after treatment to measure the bone marker Fill in two quality-of-life questionnaires before and after treatment Have one bone density scan (DXA) at the start to check they can take part
Detailed description
Bone loss accelerates after menopause because of the decline in oestrogen, raising the risk of progression from osteopenia to osteoporosis and of fractures. Current medication options are largely preventive and have limitations. High-intensity laser therapy (HILT) combined with physiotherapy is a non-invasive physical treatment that may stimulate bone formation with a favourable safety profile, but robust evidence in postmenopausal bone health is limited.
This is a randomised, double-blind, placebo (sham)-controlled, parallel-group interventional trial with two equal arms. A standardised physiotherapy programme is delivered identically in both arms as a background co-intervention, so the comparison isolates the added effect of active HILT versus sham.
Randomisation uses permuted blocks of four with 1:1 allocation, concealed with sealed opaque envelopes. Participants, the physiotherapist, the outcome assessor and the statistician are all blinded to allocation.
Intervention parameters: pulsed HILT in the near-infrared spectrum, 7 W, 5 J/cm², applied over the lumbar region (L1-L5) with a scanning handpiece for approximately 150 seconds per session, three sessions per week for four weeks. The sham arm follows an identical procedure with a device that delivers no therapeutic laser energy.
The bone-formation marker P1NP is measured in peripheral blood by ELISA (ng/mL). To avoid the confounding effect of acute exercise on bone turnover markers, the post-treatment sample is collected 72 hours (minimum 48 hours) after the last physiotherapy session, before any further physical activity, and all samples are analysed in a single batch.
Analyses follow the intention-to-treat principle on all randomised participants, with a per-protocol analysis as a supportive check. For each measure, the change from baseline is compared between arms using parametric or non-parametric tests as appropriate, with results reported as effect sizes and 95% confidence intervals. Safety is monitored throughout the treatment sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel arms with 1:1 allocation. A standardised physiotherapy programme is delivered identically in both arms as a background co-intervention; the experimental arm additionally receives active high-intensity laser therapy and the control arm a sham laser.
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Laser Therapy + Physiotherapy | Experimental | Device: High-Intensity Laser Therapy, Behavioral: Standardised Physiotherapy ProgrammeParticipants receive a standardised physiotherapy programme plus active high-intensity laser therapy (HILT). HILT is pulsed near-infrared laser, 7 W, 5 J/cm², applied over the lumbar spine (L1-L5) with a scanning handpiece for about 150 seconds per session, three sessions per week for four weeks (12 sessions total). |
| Sham Laser + Physiotherapy | Sham comparator | Device: Sham Laser, Behavioral: Standardised Physiotherapy ProgrammeParticipants receive the same standardised physiotherapy programme plus a sham laser. The sham device looks and operates identically to the active laser but delivers no therapeutic energy. It follows the same schedule: about 150 seconds per session over the lumbar spine (L1-L5), three sessions per week for four weeks (12 sessions total). |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Postmenopausal women Osteopenia or osteoporosis diagnosed by DXA (T-score below -1.0) Age 50 to 70 years Body mass index (BMI) between 18.5 and 30 Provides written informed consent
Key exclusion criteria (1 listed)
- History of fractures Use of agents that may interfere with bone metabolism (e.g., bisphosphonates, glucocorticoids, hormone therapy) Severe comorbidities or decompensation of pre-existing conditions Recent physiotherapy (within the past 3 months) Rheumatologic diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus) High-dose calcium or vitamin D supplementation Contraindications to laser therapy (cancer, active bleeding or bleeding disorders, acute infections, photosensitivity, pregnancy, implanted electronic devices, or other conditions that could interfere with laser treatment)
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 |
|---|---|---|
| High-Intensity Laser TherapyAlso: HILTPulsed near-infrared laser, 7 W, 5 J/cm², applied over the lumbar spine (L1-L5) with a scanning handpiece for about 150 seconds per session, three sessions per week for four weeks (12 sessions total). Delivered in the experimental arm only. | Device | High-Intensity Laser Therapy + Physiotherapy |
| Sham LaserAlso: Placebo laserA sham device identical in appearance and operation to the active laser but delivering no therapeutic energy. Applied on the same schedule: about 150 seconds per session over the lumbar spine (L1-L5), three sessions per week for four weeks. Delivered in the control arm only, to preserve blinding | Device | Sham Laser + Physiotherapy |
| Standardised Physiotherapy ProgrammeAlso: KinesiotherapyA standardised physiotherapy (exercise) programme delivered identically in both arms as a background co-intervention. The programme is the same in content, frequency and duration for all participants, so the comparison isolates the added effect of the active laser versus sham. | Behavioural | High-Intensity Laser Therapy + Physiotherapy, Sham Laser + Physiotherapy |
Primary outcome
Change from baseline in serum procollagen type I N-terminal propeptide (P1NP)
Time frame: Baseline and end of the 4-week intervention
P1NP is a marker of bone formation, measured in peripheral blood by enzyme-linked immunosorbent assay (ELISA) and reported in ng/mL. The post-intervention sample is collected 72 hours (minimum 48 hours) after the last physiotherapy session, before any further physical activity, and all samples are analysed in a single batch.
Change from baseline in health-related quality of life (Short Form-36, SF-36)
Time frame: Baseline and end of the 4-week intervention
SF-36 is a general health-related quality-of-life questionnaire. Scores range from 0 to 100, with higher scores indicating better quality of life.
Change from baseline in osteoporosis-specific quality of life (Qualeffo-41)
Time frame: Baseline and end of the 4-week intervention
Qualeffo-41 is a quality-of-life questionnaire specific to osteoporosis. Total scores range from 0 to 100; higher scores indicate poorer quality of life.
1 secondary outcome
Number of participants with adverse events
Time frame: Throughout the 4-week treatment period
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 29 Jul 2026.
- Background: PubMed 39410572Coroleuca R, Filipoiu FM, Cherecheanu AP, Enyedi M, Bucsan R, Bostan M, Coroleuca CA, Ladea L, Vrinceanu D, Moraru OE, Iancu R. Laser Scanning Morphometric Measurements of the Main Orbital Communications in Dry Human Skulls. Diagnostics (Basel). 2024 Sep 29;14(19):2168. doi: 10.3390/diagnostics14192168.
- Background: PubMed 31399862Fallahnezhad S, Jajarmi V, Shahnavaz S, Amini A, Ghoreishi SK, Kazemi M, Chien S, Bayat M. Improvement in viability and mineralization of osteoporotic bone marrow mesenchymal stem cell through combined application of photobiomodulation therapy and oxytocin. Lasers Med Sci. 2020 Apr;35(3):557-566. doi: 10.1007/s10103-019-02848-8. Epub 2019 Aug 9.
- Background: PubMed 38714490Lee DO, Hong YH, Cho MK, Choi YS, Chun S, Chung YJ, Hong SH, Hwang KR, Kim J, Kim H, Lee DY, Lee SR, Park HT, Seo SK, Shin JH, Song JY, Yi KW, Paik H, Lee JY. The 2024 Guidelines for Osteoporosis - Korean Society of Menopause: Part I. J Menopausal Med. 2024 Apr;30(1):1-23. doi: 10.6118/jmm.24000. No abstract available.
- Background: PubMed 37660042Abo Elyazed TI, Al-Azab IM, Abd El-Hakim AAE, Elkady SM, Afifi RMM, Obaya HE. Effect of high-intensity laser therapy versus shockwave therapy on selected outcome measures in osteoporotic long-term hemiparetic patients: a randomized control trial. J Orthop Surg Res. 2023 Sep 2;18(1):653. doi: 10.1186/s13018-023-04141-5.
- Background: PubMed 29068756Alayat MSM, Abdel-Kafy EM, Thabet AAM, Abdel-Malek AS, Ali TH, Header EA. Long-Term Effect of Pulsed Nd-YAG Laser Combined with Exercise on Bone Mineral Density in Men with Osteopenia or Osteoporosis: 1 Year of Follow-Up. Photomed Laser Surg. 2018 Feb;36(2):105-111. doi: 10.1089/pho.2017.4328. Epub 2017 Oct 25.
- Background: PubMed 36693069Macedo P, Cavalcante A, Fernandes S, Salustiano M, Lima M, Jerez-Roig J, Camara S. Association between menopausal status and physical function: A systematic review protocol. PLoS One. 2023 Jan 24;18(1):e0280786. doi: 10.1371/journal.pone.0280786. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Laser Therapy and Standardised Physiotherapy Programme in people with Osteoporosis, Postmenopausal and Osteopenia, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
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 1 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: opening soon, as of the sponsor's last update on 29 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 1 site in Romania. 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. Some participants in this study may receive a placebo. 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 Titus Vari, MD (+40 743 081 588, titus.vari@elearn.umfcluj.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in serum procollagen type I N-terminal propeptide (P1NP) (time frame: Baseline and end of the 4-week intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07734922, which also lists 6 linked publications.
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 29 Jul 2026.