OsteopeniaNCT04040010
The Effects of Bovine Colostrum in Bone Metabolism in Humans
A study testing Colostrum supplementation for bone loss in people with Osteopenia and Osteoporosis, run by Petros Dinas at 1 site in Greece.
Trial summary
Osteoporosis constitutes a major public health concern. For instance, in European Union 1 in 3 women and at least 1 in 6 men will suffer an osteoporotic fracture during their lifespan. The burden of osteoporosis is estimated to raise 25% by 2025. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Osteopenia, Osteoporosis
- What is being tested?
- Colostrum supplementation for bone loss
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 1 Sep 2019to 29 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Postmenopausal women (no menses for the last year at least);
- Osteoporosis patients (female): T-score<-2.5 at the femoral neck (or other anatomical site);
- Osteoporosis patients (male): T-score<-2.5 at the femoral neck (or other anatomical site)
- Osteopenia patients (female): T-score<-1.0 at the femoral neck (or other anatomical site);
- Osteopenia patients (male): T-score<-1.0 at the femoral neck (or other anatomical site)
- Patients taking drugs/ supplements for osteoporosis will be accepted in the study after going through a wash-up period
Who cannot join
- Women with irregular menses (i.e. with no established menopause)
- Patients taking medications for other diseases known to interfere with bone metabolism
- Patients with other chronic diseases (e.g. diabetes)
Trial locations and contacts
1 site in 1 country.
Greece1 site
FAME Lab, Department of Exercise Science, University of Thessaly
Trikala, Thessaly, 42100
About this study
Osteoporosis constitutes a major public health concern. For instance, in European Union 1 in 3 women and at least 1 in 6 men will suffer an osteoporotic fracture during their lifespan. The burden of osteoporosis is estimated to raise 25% by 2025. Worldwide, by 2050, the incidence of osteoporotic fractures is expected to increase 240% in women and 310% in men compared to 1990. The aforementioned estimates might indicate the existence of some gaps related to current products on the market for prevention and treatment of osteoporosis. Actually, the use of the approved pharmacological agents for osteoporosis have been decreasing in European Union and worldwide. Patients are becoming increasingly reluctant to take medicines; even those with severe osteoporosis are refusing treatment. Recent published reports on the matter revealed that patients fear the side effects of current pharmacological agents. Actually, therapy with bisphosphonates, the most prescribed medication for the treatment of postmenopausal, glucocorticoid-induced and male osteoporosis has been associated with severe side effects as osteonecrosis of the jaw and atypical femoral fractures.
Colostrum, a milky substance produced by mammals, known to be responsible for the development of the immune and skeleton systems of the offspring, has on its constituent's lactoferrin (LF). This multi-functional protein has been shown to affect both bone resorbing and bone formation pathways. The safety and tolerance on the use of bovine colostrum in humans (children and adults) have been well documented; it has a 'Generally Recognized As Safe' status from the United States Food and Drug Administration. Allergies and lactose intolerance, which are main shortcomings of milk consumption, have not been reported in relation to colostrum. Actually, human colostrum and bovine colostrum share the same bioactive components, but bovine sources are more potent than that of human. In accordance, bovine colostrum supplementation has been used in several therapeutic applications as gastrointestinal disorders, allergies and autoimmune diseases, viral and bacterial illnesses, and HIV-associated immunomodulation HIV. However, the effectiveness of bovine colostrum (as a whole and not only LF) to reduce bone losses has not been considered yet. Therefore, this study aims at analyzing the effects of bovine colostrum in diminishing bone mass losses in humans.
Read the detailed description
Postmenopausal women (without any bone condition), osteopenia and osteoporosis patients (female and male) will be invited to join the study. Participants enrolling the project will be first measured on the following parameters: 1) general characteristics (age, sex, medical history); 2) bone mass parameters through Dual-energy X-ray absorptiometry (DXA); 3) bone formation and resorption markers (alkaline phosphatase, osteocalcin, N-telopeptides and urine deoxypyridinoline). After measuring the aforementioned parameters, consenting participants will be randomized into the following groups: Group 1: postmenopausal women taking colostrum supplementation; Group 2: postmenopausal women taking placebo; Group 3: osteopenia patients taking colostrum supplementation; Group 4: osteopenia patients taking placebo; Group 5: osteoporosis patients taking colostrum supplementation; Group 6: osteoporosis patients taking placebo. Power calculations (90% power, 0.05%) were performed in order to calculate the sample size needed in each group (considering stratification according to group, a minimum of 7 participants in each group are needed). Following 5 months intervention, participants will be re-assessed on the following parameters: 1) general characteristics (age, sex, medical history); 2) bone mass parameters through Dual-energy X-ray absorptiometry (DXA); 3) bone formation and resorption markers (alkaline phosphatase, osteocalcin, N-telopeptides and urine deoxypyridinoline).
- Conditions
- Osteopenia, Osteoporosis
- Being tested
- Colostrum supplementation for bone loss
- Keywords
- bone metabolism, Postmenopausal women, bone markers, bovine colostrum, DXA
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colostrum supplementation for bone lossDietary supplement
Participants in the interventions groups (i.e. colostrum supplementation) will take a colostrum mixture for 5 months (5 times per week; a total of 250ml per day in liquid form). Participants in the placebo groups (i.e. controls) will be taking a placebo mixture (a total of 250ml per day in liquid form per dose) for the same period of time.
| Study group | Role | What they receive |
|---|---|---|
| Postmenopausal women colostrum supplement | Experimental | Not described Receives: Dietary Supplement: Colostrum supplementation for bone loss |
| Osteoporosis patients colostrum supplement | Experimental | Not described Receives: Dietary Supplement: Colostrum supplementation for bone loss |
| Osteopenia patients colostrum supplement | Experimental | Not described Receives: Dietary Supplement: Colostrum supplementation for bone loss |
| Postmenopausal women placebo | Placebo comparator | Not described Receives: Dietary Supplement: Colostrum supplementation for bone loss |
| Osteoporosis patients placebo | Placebo comparator | Not described Receives: Dietary Supplement: Colostrum supplementation for bone loss |
| Osteopenia patients placebo | Placebo comparator | Not described Receives: Dietary Supplement: Colostrum supplementation for bone loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of alkaline phosphatase (μg/L)
The alkaline phosphatase (μg/L) will be analyzed via human serum samples using an appropriate ELISA kit
Measured: Change from baseline of alkaline phosphatase at five months
Change of osteocalcin (μg/L)
The osteocalcin (μg/L) will be analyzed via human serum samples using an appropriate ELISA kit
Measured: Change from baseline of osteocalcin at five months
Change of deoxypyridinoline (mmol/L)
The deoxypyridinoline (mmol/L) will be analyzed via human serum samples using an appropriate ELISA kit
Measured: Change from baseline of deoxypyridinoline at five months
Change of C-terminal telopeptide (CTX) (pg/mL)
The C-terminal telopeptide (CTX) (pg/mL) will be analyzed via human serum samples using an appropriate ELISA kit
Measured: Change from baseline of C-terminal telopeptide at five months
Change of bone mineral density (g/cm2)
The bone mineral density (g/cm2) will be analyzed via Dual-energy X-ray absorptiometry scan
Measured: Change from baseline of bone mineral density at five months
Change of bone mineral content (gr)
The bone mineral content (gr) will be analyzed via Dual-energy X-ray absorptiometry scan
Measured: Change from baseline of bone mineral content at five months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start1 Sep 2019
- Primary completion29 Feb 2020
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopeniaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Petros Dinas
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Sponsor-investigator, Petros Dinas, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04040010
- Sponsor's protocol ID
- 3. Colostrum & bone
- Status last verified
- Nov 2020
- First submitted
- 26 Jul 2019
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Bovine Colostrum in Bone Metabolism in Humans
- ClinicalTrials.gov ID
- NCT04040010
- Acronym / sponsor ID
- 3. Colostrum & bone
- Conditions
- Osteopenia, Osteoporosis
- Keywords
- bone metabolism, Postmenopausal women, bone markers, bovine colostrum, DXA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Petros DinasUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 31 Jul 2019 (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.
Osteoporosis constitutes a major public health concern. For instance, in European Union 1 in 3 women and at least 1 in 6 men will suffer an osteoporotic fracture during their lifespan. The burden of osteoporosis is estimated to raise 25% by 2025. Worldwide, by 2050, the incidence of osteoporotic fractures is expected to increase 240% in women and 310% in men compared to 1990. The aforementioned estimates might indicate the existence of some gaps related to current products on the market for prevention and treatment of osteoporosis. Actually, the use of the approved pharmacological agents for osteoporosis have been decreasing in European Union and worldwide. Patients are becoming increasingly reluctant to take medicines; even those with severe osteoporosis are refusing treatment. Recent published reports on the matter revealed that patients fear the side effects of current pharmacological agents. Actually, therapy with bisphosphonates, the most prescribed medication for the treatment of postmenopausal, glucocorticoid-induced and male osteoporosis has been associated with severe side effects as osteonecrosis of the jaw and atypical femoral fractures.
Colostrum, a milky substance produced by mammals, known to be responsible for the development of the immune and skeleton systems of the offspring, has on its constituent's lactoferrin (LF). This multi-functional protein has been shown to affect both bone resorbing and bone formation pathways. The safety and tolerance on the use of bovine colostrum in humans (children and adults) have been well documented; it has a 'Generally Recognized As Safe' status from the United States Food and Drug Administration. Allergies and lactose intolerance, which are main shortcomings of milk consumption, have not been reported in relation to colostrum. Actually, human colostrum and bovine colostrum share the same bioactive components, but bovine sources are more potent than that of human. In accordance, bovine colostrum supplementation has been used in several therapeutic applications as gastrointestinal disorders, allergies and autoimmune diseases, viral and bacterial illnesses, and HIV-associated immunomodulation HIV. However, the effectiveness of bovine colostrum (as a whole and not only LF) to reduce bone losses has not been considered yet. Therefore, this study aims at analyzing the effects of bovine colostrum in diminishing bone mass losses in humans.
Detailed description
Postmenopausal women (without any bone condition), osteopenia and osteoporosis patients (female and male) will be invited to join the study. Participants enrolling the project will be first measured on the following parameters: 1) general characteristics (age, sex, medical history); 2) bone mass parameters through Dual-energy X-ray absorptiometry (DXA); 3) bone formation and resorption markers (alkaline phosphatase, osteocalcin, N-telopeptides and urine deoxypyridinoline). After measuring the aforementioned parameters, consenting participants will be randomized into the following groups: Group 1: postmenopausal women taking colostrum supplementation; Group 2: postmenopausal women taking placebo; Group 3: osteopenia patients taking colostrum supplementation; Group 4: osteopenia patients taking placebo; Group 5: osteoporosis patients taking colostrum supplementation; Group 6: osteoporosis patients taking placebo. Power calculations (90% power, 0.05%) were performed in order to calculate the sample size needed in each group (considering stratification according to group, a minimum of 7 participants in each group are needed). Following 5 months intervention, participants will be re-assessed on the following parameters: 1) general characteristics (age, sex, medical history); 2) bone mass parameters through Dual-energy X-ray absorptiometry (DXA); 3) bone formation and resorption markers (alkaline phosphatase, osteocalcin, N-telopeptides and urine deoxypyridinoline).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 6
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Postmenopausal women colostrum supplement | Experimental | Dietary Supplement: Colostrum supplementation for bone loss |
| Osteoporosis patients colostrum supplement | Experimental | Dietary Supplement: Colostrum supplementation for bone loss |
| Osteopenia patients colostrum supplement | Experimental | Dietary Supplement: Colostrum supplementation for bone loss |
| Postmenopausal women placebo | Placebo comparator | Dietary Supplement: Colostrum supplementation for bone loss |
| Osteoporosis patients placebo | Placebo comparator | Dietary Supplement: Colostrum supplementation for bone loss |
| Osteopenia patients placebo | Placebo comparator | Dietary Supplement: Colostrum supplementation for bone loss |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Postmenopausal women (no menses for the last year at least);
- Osteoporosis patients (female): T-score<-2.5 at the femoral neck (or other anatomical site);
- Osteoporosis patients (male): T-score<-2.5 at the femoral neck (or other anatomical site)
- Osteopenia patients (female): T-score<-1.0 at the femoral neck (or other anatomical site);
- Osteopenia patients (male): T-score<-1.0 at the femoral neck (or other anatomical site)
Key exclusion criteria (3 listed)
- Women with irregular menses (i.e. with no established menopause)
- Patients taking medications for other diseases known to interfere with bone metabolism
- Patients with other chronic diseases (e.g. diabetes)
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 |
|---|---|---|
| Colostrum supplementation for bone lossParticipants in the interventions groups (i.e. colostrum supplementation) will take a colostrum mixture for 5 months (5 times per week; a total of 250ml per day in liquid form). Participants in the placebo groups (i.e. controls) will be taking a placebo mixture (a total of 250ml per day in liquid form per dose) for the same period of time. | Dietary supplement | Osteopenia patients colostrum supplement, Osteopenia patients placebo, Osteoporosis patients colostrum supplement, Osteoporosis patients placebo, Postmenopausal women colostrum supplement, Postmenopausal women placebo |
Primary outcome
Change of alkaline phosphatase (μg/L)
Time frame: Change from baseline of alkaline phosphatase at five months
The alkaline phosphatase (μg/L) will be analyzed via human serum samples using an appropriate ELISA kit
Change of osteocalcin (μg/L)
Time frame: Change from baseline of osteocalcin at five months
The osteocalcin (μg/L) will be analyzed via human serum samples using an appropriate ELISA kit
Change of deoxypyridinoline (mmol/L)
Time frame: Change from baseline of deoxypyridinoline at five months
The deoxypyridinoline (mmol/L) will be analyzed via human serum samples using an appropriate ELISA kit
Change of C-terminal telopeptide (CTX) (pg/mL)
Time frame: Change from baseline of C-terminal telopeptide at five months
The C-terminal telopeptide (CTX) (pg/mL) will be analyzed via human serum samples using an appropriate ELISA kit
Change of bone mineral density (g/cm2)
Time frame: Change from baseline of bone mineral density at five months
The bone mineral density (g/cm2) will be analyzed via Dual-energy X-ray absorptiometry scan
Change of bone mineral content (gr)
Time frame: Change from baseline of bone mineral content at five months
The bone mineral content (gr) will be analyzed via Dual-energy X-ray absorptiometry scan
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colostrum supplementation for bone loss in people with Osteopenia and Osteoporosis, run by Petros Dinas at 1 site in Greece.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 6 Nov 2020. 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 Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of alkaline phosphatase (μg/L) (time frame: Change from baseline of alkaline phosphatase at five months). The study lists 6 primary outcomes in all. 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 6 Nov 2020.