An interventional study of High-Intensity Laser Therapy and Sham Laser in Osteoporosis, Postmenopausal and Osteopenia, sponsored by Iuliu Hatieganu University of Medicine and Pharmacy. Not yet recruiting at 1 site in Romania. Open to female participants aged 50 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Iuliu Hatieganu University of Medicine and Pharmacy · Not applicable, Interventional, and Treatment
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
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.
334 studies on the registry are indexed under Osteoporosis, Postmenopausal; 28 are open to participants now.
This study's planned enrollment of 40 is below the median of 119 across 264 interventional studies indexed under Osteoporosis, Postmenopausal.
Browse Osteoporosis, Postmenopausal studies →Iuliu Hatieganu University of Medicine and Pharmacy is the lead sponsor of 56 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
women Osteopenia or osteoporosis diagnosed by DXA (T-score below -1.0) Age 50 to 70 years (BMI) between 18.5 and 30 Provides written
Exclusion Criteria:
History of fractures Use of agents that may interfere with bone metabolism (e.g., bisphosphonates, , 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 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)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Device: High-Intensity Laser Therapy · Behavioral: Standardised Physiotherapy Programme
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).
Device: Sham Laser · Behavioral: Standardised Physiotherapy Programme
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.
Also known as: HILT
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
Also known as: Placebo laser
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.
Also known as: Kinesiotherapy
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and end of the 4-week intervention
Number of participants with adverse events
Adverse events are monitored throughout the treatment sessions and recorded by type, severity and relationship to the intervention.
Time frame: Throughout the 4-week treatment period
Plan to share: No
Start is estimated for Jul 2026; primary completion for Jan 2027, 6 months later.
Of 47 non-industry interventional studies with no phase under Osteoporosis, Postmenopausal, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 34. This study's planned 6 months is below that.
Counting every sponsor, half of 50 studies reached it within 17 months; a quarter within 9 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Osteoporosis, Postmenopausal →
Iuliu Hatieganu University of Medicine and Pharmacy