OsteopeniaPhase 3NCT03260803
Oligopin Supplementation and Bone Turnover Markers and Antioxidant Changes in Postmenopausal Osteopenic Women
A Phase 3 study testing Oligopin in people with Osteopenia, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
Osteoporosis fractures impose a significant economic burden on the health system. There is evidence that osteoporosis has a high prevalence in Iran (4.8% for men and 7.7% for women), and the frequency of osteopenia is 36.8% for men and 39.3% for women in Iran Accordingly, the prevention of osteopenia progression… Read more about this study
- Who is it for?
- Ages 50 to 65 years, women only
- Conditions the study is for
- Osteopenia
- What is being tested?
- Oligopin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteIran
- Study dates
- 1 Feb 2018to 1 Mar 2019
- Phase
- Phase 3
- 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 50 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria: Postmenopausal women; Aged between 50-65; Diagnosis of osteopenia based on Tscore ( -2.5 SD ≤ Tscore ≤ -1 SD); To have equal physical, pediatric and complementary therapies for at least three months before entrance to study ;Absence of history of Bone Diseases; Absence of the history of chronic diseases including cancer, diabetes, kidney failure, liver disease, systemic inflammatory diseases, degenerative joint diseases and rheumatologic disorders, primary thalassemia, hyperparathyroidism, hyperthyroidism-Cushing's, Hypercalcaemia syndrome, Hyperglycemia ;Absence of gastrointestinal disease including Crohn's disease, ulcerative colitis, celiac disease, and chronic diarrhea and gastric or duodenal ulcers treated or with a history of gastrointestinal bleeding (according to the patient's history); Absence of history of the use of drugs that affect bone metabolism and have been regularly used for at least 6 months in the past two years: such as osteoporosis drugs (bisphosphonates, estrogen receptor selective agonists / selective antagonists, alternative HRTs, PTH), diuretics, thiazides, anticonvulsants (phenytoin, phenobarbital, sodium valproate), glucocorticoids, nonsteroidal anti-inflammatory drugs such as analgesics (nonsteroidal anti-inflammatory drugs such as naproxen, aspirin and ibuprofen), cigarettes; Absence of motor disabilities, skeletal disorders, untreated psychiatric illnesses such as psychosis, Alzheimer's disease, Parkinson's disease; To accept randomization; Absence of morbid Obesity: BMI is above 40
Who cannot join
- Fracture report during the study period; Unwillingness of participants to continue the project; The occurrence of any visible side effects of supplemental effects
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Valuating the Effects of Oligopin Supplementation on the Turnover of Bone Formation and Antioxidant Changes in Postmenopausal Osteopenic Women: A Randomized Double-blind Clinical Trial With Placebo-concurrent Controls
Osteoporosis fractures impose a significant economic burden on the health system. There is evidence that osteoporosis has a high prevalence in Iran (4.8% for men and 7.7% for women), and the frequency of osteopenia is 36.8% for men and 39.3% for women in Iran Accordingly, the prevention of osteopenia progression towards osteoporosis has been considered as an important issue in medicine. Bone is a dynamic tissue that is constantly being remodeled thus the equilibrium between bone formation and resorption done by simultaneously regulating osteoclasts and osteoblasts is important. Imbalance between bone deposition and resorption contributes to reducing bone mineral density and hence increasing the risk of osteoporosis
Recently, new therapies have been focused on use of medicinal herbs, especially phytochemicals. Among phytochemicals, phytonutrients, and especially polyphenols, can act both on osteoblast and on osteoclast.
Pine bark extract (oligopin) is a rich source of polyphenols that exerts strong antioxidant and anti-inflammatory activities. It has also beneficial effects on bone turnover based on in vitro studies and animal models. Investigators aimed to investigate the effects of oligopin on bone turnover markers and plasma and peripheral mononuclear cells oxidative stress in postmenopausal women with osteopenia in a double-blind randomized clinical trial. Participants are forty four women with osteopenia divided into two groups randomly (22, having oligopin, 150 mg, once daily, for 12 weeks). The 2nd group (22 women with osteopenia) receives the same amount of the placebo. At the first and the end of the study, blood sample are taken to measure in order to peripheral blood mononuclear cells isolation and plasma separation. The levels of bone alkaline phosphatase and carboxy terminal collagen type I in plasma oxidative stress markers such as total anti-oxidant capacity, malondialdehyde, and protein carbonyl were evaluated. Furthermore, oxidative stress will be evaluated in peripheral blood mononuclear cells by measurement of expression and activity of magnesium superoxide dismutase,catalase and Nuclear factor (erythroid-derived 2)-like 2.
- Conditions
- Osteopenia
- Being tested
- Oligopin, Placebo
- Keywords
- osteopenia, oligopin, postmenopause, antioxidant, bone
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OligopinDrug
Oligopin ,150 mg ,once daily, 12 week
PlaceboDrug
Placebo,150 mg ,once daily, 12 week
| Study group | Role | What they receive |
|---|---|---|
| postmenopausal osteopenic women receiveing Oligopin | Experimental | postmenopausal osteopenic women receiving Oligopin ,150 mg ,once daily, 12 week Receives: Drug: Oligopin |
| postmenopausal osteopenic women receiving placebo | Placebo comparator | postmenopausal osteopenic women receiving placebo, 150 mg,once daily,12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Osteocalcin Concentration
Osteocalcin levels in plasma
Measured: up to third month after intervention
Plasma Carboxyl terminal collagen type I Concentration
Carboxyl terminal collagen type I in plasma
Measured: up to third month after intervention
Osteocalcin/Carboxyl terminal collagen type I ratio
Osteocalcin/Carboxyl terminal collagen type I ratio
Measured: up to third month after intervention
Secondary outcomes (11)
MnSOD activity in peripheral blood mononuclear cells
MnSOD activity in peripheral blood mononuclear cells
Measured: Baseline and third month after intervention
Catalase activity in peripheral blood mononuclear cells
Catalase activity in peripheral blood mono nuclear cells
Measured: Baseline and third month after intervention
MnSOD mRNA expression peripheral blood mononuclear cells
MnSOD mRNA expression peripheral blood mononuclear cells
Measured: Baseline and third month after intervention
Catalase mRNA expression peripheral blood mononuclear cells
Catalase mRNA expression peripheral blood mononuclear cells
Measured: Baseline and third month after intervention
NrF2 mRNA expression peripheral blood mononuclear cells
NrF2 mRNA expression peripheral blood mononuclear cells
Measured: Baseline and third month after intervention
Plasma Malondialdehide Concentration
Malondialdehide levels in plasma
Measured: Baseline and third month after intervention
total antioxidant capacity
total antioxidant capacity in plasma
Measured: Baseline and third month after intervention
protein carbonyl content
protein carbonyl content in plasma
Measured: Baseline and third month after intervention
Plasma Total thiol concentration
Total thiol level in plasma
Measured: Baseline and third month after intervention
Catalase activity in Plasma
Catalase activity in plasma
Measured: Baseline and third month after intervention
MnSOD activity in Plasma
MnSOD activity in plasma
Measured: Baseline and third month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start1 Feb 2018
- Primary completion1 Dec 2018
- Study completion1 Mar 2019
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Iran University of Medical Sciences
- Responsible party
- Principal investigator, Solaleh EmamGholi, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260803
- Sponsor's protocol ID
- 34606
- Status last verified
- May 2020
- First submitted
- 22 Aug 2017
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valuating the Effects of Oligopin Supplementation on the Turnover of Bone Formation and Antioxidant Changes in Postmenopausal Osteopenic Women: A Randomized Double-blind Clinical Trial With Placebo-concurrent Controls
- ClinicalTrials.gov ID
- NCT03260803
- Acronym / sponsor ID
- 34606
- Conditions
- Osteopenia
- Keywords
- osteopenia, oligopin, postmenopause, antioxidant, bone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Collaborators
- Iran University of Medical Sciences
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 24 Aug 2017 (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 fractures impose a significant economic burden on the health system. There is evidence that osteoporosis has a high prevalence in Iran (4.8% for men and 7.7% for women), and the frequency of osteopenia is 36.8% for men and 39.3% for women in Iran Accordingly, the prevention of osteopenia progression towards osteoporosis has been considered as an important issue in medicine. Bone is a dynamic tissue that is constantly being remodeled thus the equilibrium between bone formation and resorption done by simultaneously regulating osteoclasts and osteoblasts is important. Imbalance between bone deposition and resorption contributes to reducing bone mineral density and hence increasing the risk of osteoporosis
Recently, new therapies have been focused on use of medicinal herbs, especially phytochemicals. Among phytochemicals, phytonutrients, and especially polyphenols, can act both on osteoblast and on osteoclast.
Pine bark extract (oligopin) is a rich source of polyphenols that exerts strong antioxidant and anti-inflammatory activities. It has also beneficial effects on bone turnover based on in vitro studies and animal models. Investigators aimed to investigate the effects of oligopin on bone turnover markers and plasma and peripheral mononuclear cells oxidative stress in postmenopausal women with osteopenia in a double-blind randomized clinical trial. Participants are forty four women with osteopenia divided into two groups randomly (22, having oligopin, 150 mg, once daily, for 12 weeks). The 2nd group (22 women with osteopenia) receives the same amount of the placebo. At the first and the end of the study, blood sample are taken to measure in order to peripheral blood mononuclear cells isolation and plasma separation. The levels of bone alkaline phosphatase and carboxy terminal collagen type I in plasma oxidative stress markers such as total anti-oxidant capacity, malondialdehyde, and protein carbonyl were evaluated. Furthermore, oxidative stress will be evaluated in peripheral blood mononuclear cells by measurement of expression and activity of magnesium superoxide dismutase,catalase and Nuclear factor (erythroid-derived 2)-like 2.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| postmenopausal osteopenic women receiveing Oligopin | Experimental | Drug: Oligopinpostmenopausal osteopenic women receiving Oligopin ,150 mg ,once daily, 12 week |
| postmenopausal osteopenic women receiving placebo | Placebo comparator | Drug: Placebopostmenopausal osteopenic women receiving placebo, 150 mg,once daily,12 weeks |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria: Postmenopausal women; Aged between 50-65; Diagnosis of osteopenia based on Tscore ( -2.5 SD ≤ Tscore ≤ -1 SD); To have equal physical, pediatric and complementary therapies for at least three months before entrance to study ;Absence of history of Bone Diseases; Absence of the history of chronic diseases including cancer, diabetes, kidney failure, liver disease, systemic inflammatory diseases, degenerative joint diseases and rheumatologic disorders, primary thalassemia, hyperparathyroidism, hyperthyroidism-Cushing's, Hypercalcaemia syndrome, Hyperglycemia ;Absence of gastrointestinal disease including Crohn's disease, ulcerative colitis, celiac disease, and chronic diarrhea and gastric or duodenal ulcers treated or with a history of gastrointestinal bleeding (according to the patient's history); Absence of history of the use of drugs that affect bone metabolism and have been regularly used for at least 6 months in the past two years: such as osteoporosis drugs (bisphosphonates, estrogen receptor selective agonists / selective antagonists, alternative HRTs, PTH), diuretics, thiazides, anticonvulsants (phenytoin, phenobarbital, sodium valproate), glucocorticoids, nonsteroidal anti-inflammatory drugs such as analgesics (nonsteroidal anti-inflammatory drugs such as naproxen, aspirin and ibuprofen), cigarettes; Absence of motor disabilities, skeletal disorders, untreated psychiatric illnesses such as psychosis, Alzheimer's disease, Parkinson's disease; To accept randomization; Absence of morbid Obesity: BMI is above 40
Key exclusion criteria (2 listed)
- Fracture report during the study period; Unwillingness of participants to continue the project; The occurrence of any visible side effects of supplemental effects
- -
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 |
|---|---|---|
| OligopinOligopin ,150 mg ,once daily, 12 week | Drug | postmenopausal osteopenic women receiveing Oligopin |
| PlaceboPlacebo,150 mg ,once daily, 12 week | Drug | postmenopausal osteopenic women receiving placebo |
Primary outcome
Plasma Osteocalcin Concentration
Time frame: up to third month after intervention
Osteocalcin levels in plasma
Plasma Carboxyl terminal collagen type I Concentration
Time frame: up to third month after intervention
Carboxyl terminal collagen type I in plasma
Osteocalcin/Carboxyl terminal collagen type I ratio
Time frame: up to third month after intervention
Osteocalcin/Carboxyl terminal collagen type I ratio
11 secondary outcomes
MnSOD activity in peripheral blood mononuclear cells
Time frame: Baseline and third month after intervention
Catalase activity in peripheral blood mononuclear cells
Time frame: Baseline and third month after intervention
MnSOD mRNA expression peripheral blood mononuclear cells
Time frame: Baseline and third month after intervention
Catalase mRNA expression peripheral blood mononuclear cells
Time frame: Baseline and third month after intervention
NrF2 mRNA expression peripheral blood mononuclear cells
Time frame: Baseline and third month after intervention
Plasma Malondialdehide Concentration
Time frame: Baseline and third month after intervention
total antioxidant capacity
Time frame: Baseline and third month after intervention
protein carbonyl content
Time frame: Baseline and third month after intervention
Plasma Total thiol concentration
Time frame: Baseline and third month after intervention
Catalase activity in Plasma
Time frame: Baseline and third month after intervention
MnSOD activity in Plasma
Time frame: Baseline and third month after intervention
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 20 May 2020.
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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 Phase 3 study testing Oligopin in people with Osteopenia, run by Tehran University of Medical Sciences at 1 site in Iran.
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 2 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 20 May 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 Iran. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Plasma Osteocalcin Concentration (time frame: up to third month after 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?
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 20 May 2020.