An observational study in Bone Disease, Metabolic and Physical Activity, sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-11.
Sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Observational
Among 24 studies in Bone Diseases, Metabolic with a site in Italy — 7 open to participants now, 8 under way, none of them phase 3. Bone Diseases, Metabolic · Italy.
Among the 24 studies in Bone Diseases, Metabolic with a site in Italy, this one is the only one that started in 2016, is one of 5 observational ones, and was the 10th registered.
661 studies on the registry are indexed under Bone Diseases, Metabolic; 93 are open to participants now.
Browse Bone Diseases, Metabolic studies →7 of the 24 studies in Bone Diseases, Metabolic with a site in Italy are open now. Recruiting first, the newest first:
Meyer Children's Hospital IRCCS · Sites in Italy
Ages 5–18
Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo · Sites in Italy
Ages 18+ · Healthy volunteers
Istituto Ortopedico Rizzoli · Sites in Italy
Ages 18+
Istituto Ortopedico Rizzoli · Sites in Italy
Ages 40+
ANTIMO · Sites in Italy
Ages 65+
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 63 Bone Diseases, Metabolic studies recruiting now, 27 (43%) set no upper age limit and 28 (44%) stop at 75 or younger; 12 take children under 18; 22 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
24 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2016.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 200 is above the median of 80 across 138 observational studies indexed under Bone Diseases, Metabolic.
Median enrollment 99 across the 19 interventional studies, 120 across the 5 observational. Of the 15 that completed or were terminated, 5 (33%) have results posted.
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7 of 24 have an industry lead sponsor. The 10 most frequent:
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio is the lead sponsor of 160 studies on the registry; 59 are open to participants now.
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio has 1 study filed under Bone Diseases, Metabolic — fewer than ten, so there is no comparison to draw.
1 of the studies in Bone Diseases, Metabolic with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06551155Istituto Ortopedico RizzoliPeripheral Mononuclear Cells to Screen, Monitor and Stratify the Population at Risk of Osteoporosis and Fractures | 2026-12-21 |
Among the 24 studies in Bone Diseases, Metabolic with a site in Italy, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Physical activity is a key stimulus for bone metabolism through both direct mechanisms (e.g., as a result of the applied load and/or impact) and indirect mechanisms (e.g., the activation of several metabolic pathways and the production of several mediators and effectors that have systemic effects). However, different kinds of physical activity exert different effects on bone and endocrine system.
Aim of the study is to investigate the effects of different kinds of physical activity on bone metabolism and on the relationships existing between bone metabolism, energy metabolism, hormone profile, and organ functionality.
Genetics explain about 70% of the inter-individual variance of bone mineral density (BMD) but maintenance and acquisition of bone mass strikingly depend on environmental factors as diet, calcium intake (in both quantitative and qualitative terms), and physical activity (PA). Among these, the biomechanical load generated by different kinds of PA represents the most important physiological stimulus able to increase bone mass and density.
Bone is a metabolically active tissue that undergoes to continuous remodeling throughout the coupling of resorption (operated by osteoclasts) and formation (operated by osteoblasts). Osteocytes, the quiescent form of osteoblasts, regulate the activity of the other two cell types and directly respond to load. Under normal conditions, resorption and formation are strikingly coupled and this guarantees an equilibrium between old bone matrix removal and new matrix deposition. This equilibrium is dependent upon several hormones and local mediators (e.g., cytokines, myokines, adipokines). Physiological (e.g., growth, aging, PA) and pathological conditions (e.g., metabolic diseases, bed rest, drugs) inbalance this equilibrium towards one side and, hence, affect bone mass. Regarding PA, for example, it is known that weight-bearing aerobic activity has positive effects on BMD and, hence, it is considered a preventive strategy against post-menopausal bone loss.
Differently from radiological imaging, that gives information about established architectural changes happened at a specific site in bone, biochemical and molecular markers of bone turnover give an instantaneous picture of the metabolic status of bone cells and, possibly, their immediate response to a stimulus.
Other than the bony response, PA activates several endocrine responses and particularly, the whole set of responses needed for managing the energy stores and to save the most nobile functions (e.g., brain, hearth). Hence, bone is subjected to the endocrine regulation of energy usage but, as recently discovered, being it the primary mechanosensor of load, it acts itself as an endocrine organ able to signal to other tissues and organs the changing environmental conditions.
Although several molecular aspects about the effects of PA on bone metabolism and the bone-energy cross-talk, a number of unresolved questions still exists. The study of different physiological models (i.e., athletes belonging to different disciplines) might allow the identification of common mechanisms regulating the response to PA and, from another side, to understand the physiological response to different stresses applied onto the muscle-skeletal apparatus.
The general aim of this study is to investigate the effects of different kinds of professional physical activity on bone metabolism and the relationship between bone metabolism, energy metabolism, hormone profile, and organ functionality.
The primary aim is to deepen the knowledge of the molecular mechanisms by which PA modulates bone metabolism. Specifically, this study will evaluate the bony effects of specific kinds of PA, over the time (over an entire season, over consecutive seasons, during different phases of a season), as well as the direct comparison of the bony effects of different kinds of PA and training.
Secondary aims are:
This is a perspective monocentric pilot study with different components:
A total of 200 subjects will be recruited. They will be recruited among professional athletes and technical staff of the cooperating teams
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.
Exclusion Criteria:
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.
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.
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.
Professional athletes: Professional athletes belonging to different discipline
Other: blood and saliva tests
Blood and saliva will be tested for: bone turnover markers, cytokines, chemokines, adipokines, myokines and hormones regulating bone and energy metabolism
Bone turnover markers
different markers of bone turnover (osteocalcin, N-terminal type I pro-collagen, beta-crosslaps, osteopontin, bone-alkaline phosphatase, tartrate-resistant acid phosphatase 5b) will be tested depending on the group of subjects considered time-by-time
Time frame: 0-36 Months
myokines, adipokines, cytokines, chemokines, hormones regulating bone and energy metabolism
different markers will be assayed depending on the group of subjects
Time frame: 0-36 Months
Plan to share: No — Case Report Form (CRF) will be available
Started Feb 2016 (actual). Primary completion is estimated for Feb 2026, 120 months after the start.
Of 51 non-industry observational studies under Bone Diseases, Metabolic, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 19. This study's planned 120 months is above that.
Counting every sponsor, half of 52 studies reached it within 60 months; a quarter within 19.
How these figures are worked out, and which studies are left out of them.
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